Clinical Trials News

Hawaii Biotech Initiates Phase 1 Clinical Trial For Dengue Vaccine

2009-08-26T02:47:00.000-07:00

Hawaii Biotech, Inc. President and CEO Elliot Parks, Ph.D., announced that the company has initiated a Phase 1 clinical study with its monovalent dengue vaccine candidate. The double-blind, placebo controlled, dose escalation safety study in healthy subjects is being conducted at the St. Louis University Center for Vaccine Development. http://vaccine.slu.edu/ Vaccine recipients in this study will also be monitored for virus neutralizing antibodies.

"This dengue clinical study is an important milestone in Hawaii Biotech's maturation as a clinical stage company. In addition it confirms the versatility of our subunit vaccine technology platform," Parks notes. "This Phase 1 study will also prepare us for the initial clinical testing of Hawaii Biotech's tetravalent dengue vaccine."

Hawaii Biotech's dengue monovalent vaccine candidate is the first recombinant subunit vaccine for dengue to enter clinical studies. Previous dengue vaccine candidates tested in the clinic have been either live-attenuated or DNA-based vaccines. Hawaii Biotech intends to test a dengue tetravalent vaccine candidate, developed using the company's recombinant subunit vaccine technology, within a year.

The first phase of clinical development program is designed to assess safety, determine a dose range and identify potential side effects. Results from this clinical study are expected within a year.

Hawaii Biotech's dengue subunit vaccine candidate has been developed with financial assistance from the National Institutes of Health, the Department of Defense, and the Pediatric Dengue Vaccine Initiative.

About Dengue: Dengue, also known as "break-bone fever," is a prevalent infectious disease in tropical and subtropical countries throughout the world. Approximately 3.5 billion people live in endemic countries and about 100 million people are infected with dengue every year. Dengue infections result in an estimated 20,000 deaths. Dengue is caused by one of four closely related, but distinct, virus serotypes (DEN1, DEN2, DEN3, and DEN4), of the family Flaviviridae, which also includes yellow fever, West Nile, Japanese encephalitis, and tick-borne encephalitis viruses. Dengue is transmitted by the bite of a mosquito infected with any one of the four dengue viruses. Infection with dengue virus results in severe flu-like symptoms that can lead to a life-threatening hemorrhagic fever. During the last quarter century, many tropical regions of the world have seen an increase in dengue cases. The southern United States is potentially susceptible to dengue epidemics as the types of mosquitoes that transmit dengue virus are prevalent there.

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Start Of U.S. H1N1 Vaccine Clinical Trials

2009-08-26T02:45:00.000-07:00

CSL Biotherapies has announced the initiation of the company's first U.S. clinical trials of its candidate Influenza A/H1N1 2009 vaccine. Study investigators will administer vaccinations to the first U.S. study volunteers today, August 24. The studies will determine the safety of CSL's candidate vaccine and its ability to elicit an immune response (also referred to as immunogenicity) in adults and children. The pediatric study will evaluate CSL's candidate vaccine in a thimerosal-free (i.e., preservative-free) formulation.

The clinical studies are sponsored by CSL Biotherapies and are being funded in whole or in part with Federal funds from the U.S. Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority. They will take place at 24 study sites throughout the country. It is anticipated that findings from these trials will be used to determine the most appropriate dosing schedule of the Influenza A/H1N1 2009 vaccine for use in the general population. This clinical trial program is part of a larger, global effort by CSL Biotherapies, in partnership with government and regulatory bodies, to bring an Influenza A/H1N1 2009 vaccine to market in the United States, in Australia and in select regions of the southern hemisphere.

"The H1N1 pandemic has had a significant toll on the health and well-being of people worldwide, which makes the development of an effective vaccine against the virus an urgent public health need," said Kawsar Talaat, MD, principal investigator of the CSL vaccine adult trials and assistant scientist in the Johns Hopkins Bloomberg School's Department of International Health. "Through these trials, we hope to identify the most effective dose and dosing regimen to protect the public against this highly infectious new strain of influenza virus."

"Children are often at greater risk from influenza infection and its complications than adults, so it is extremely important to understand the efficacy of an H1N1 vaccine in this very vulnerable population," said Pedro Piedra, MD, principal investigator for the vaccine pediatric trials and professor in the department of molecular virology and microbiology, and pediatrics at Baylor College of Medicine. "The clinical trials of CSL's candidate vaccine will be the first to use a thimerosal-free formulation of the H1N1 vaccine antigen."

About CSL's H1N1 Clinical Trial Initiative

The goal of CSL's H1N1 clinical trial program is to evaluate the safety and efficacy of the Influenza A/H1N1 2009 vaccine in adults and children (http://www.clinicaltrials.gov). Approximately 1,300 adults (aged 18 years and older) and 450 children (aged ≥ 3 months to < 9 years) are expected to be enrolled in the randomized, placebo-controlled U.S. studies. In the adult trials, three doses of the vaccine - 7.5, 15 and 30 mcg - will be evaluated, administered as two vaccinations, three weeks apart.

In the pediatric trials, two doses - 7.5 and 15 mcg - will be evaluated, administered as two vaccinations, three weeks apart. The studies will also evaluate the incidence of adverse events up to six months after first injection. CSL's Influenza A/H1N1 2009 vaccine is manufactured by a process identical to the one used in manufacturing CSL's U.S. Food and Drug Administration-licensed trivalent seasonal influenza vaccine; only the single A/H1N1 flu strain differs between the two.

CSL Limited, the parent company of CSL Biotherapies, initiated Australian clinical trials of its Influenza A/H1N1 2009 vaccine candidate with a design and study objectives similar to its U.S. program. First administration in healthy adult volunteers began on July 22, 2009 and in healthy pediatric volunteers on August 3, 2009, making CSL the first vaccine manufacturer to initiate human studies of this vaccine. CSL expects to report interim post-dose 1 data from the adult trials in Australia by mid-September.

CSL Biotherapies recently signed an initial contract for $180 million to supply the U.S. Department of Health & Human Services with Novel influenza A (H1N1) antigen.

About Influenza and the Novel Influenza A/H1N1 Virus

Influenza (commonly referred to as the flu) is a serious illness that accounts for approximately 36,000 deaths annually in the U.S. While most healthy individuals recover from influenza within a few days to a week, some people, especially those with certain chronic illnesses, such as heart or lung disease, can develop complications. Seasonal influenza vaccination has been shown to reduce illness, hospitalization and death. The emergence of the novel H1N1 flu, which was first detected in humans in April 2009, has proven to be very contagious, spreading worldwide, and has led to the World Health Organization declaring a pandemic on June 11, 2009. The pandemic virus has caused more than a thousand deaths worldwide and created a significant burden on hospitals.

Vaccination against pandemic influenza is the most important step in bringing the pandemic under control and protecting those most at risk from infection. CSL Biotherapies is developing and producing candidate Influenza A/H1N1 2009 vaccine, drawing on four decades of experience with its proven vaccine production processes.

Brentuximab Vedotin (SGN-35) Pivotal Trial For Patients With Hodgkin Lymphoma

2009-08-26T02:38:00.000-07:00

Seattle Genetics, Inc. (Nasdaq:SGEN) announced that it has completed enrollment of its pivotal clinical trial of brentuximab vedotin (SGN-35) for relapsed and refractory Hodgkin lymphoma. Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30 utilizing the company's proprietary ADC technology.

"Strong interest in brentuximab vedotin from investigators and patients has allowed us to rapidly complete our target enrollment of 100 patients in the pivotal trial in six months, emphasizing the substantial unmet medical need in the relapsed and refractory Hodgkin lymphoma setting," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "The pivotal trial allows for patient treatment up to approximately one year, and we expect data to be available in the second half of 2010. Our goal is to submit both a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) under the accelerated approval regulations and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) for conditional marketing authorization in the first half of 2011. Assuming priority review of our NDA, we would then plan to commercially launch the drug in the United States in the second half of 2011, with potential European launch to follow."

The brentuximab vedotin pivotal trial is a single-agent, single-arm study evaluating 100 patients with relapsed or refractory Hodgkin lymphoma who previously received autologous stem cell transplant. Patients receive 1.8 milligrams per kilogram (mg/kg) of brentuximab vedotin every three weeks. The primary endpoint of the study is objective response rate assessed by independent review. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability. The pivotal trial is being conducted under a Special Protocol Assessment (SPA) from the FDA. The SPA is an agreement between the FDA and Seattle Genetics regarding the design of the pivotal trial, including size and clinical endpoints necessary to support an efficacy claim in an NDA. Brentuximab vedotin has also been granted fast track designation by the FDA for the treatment of Hodgkin lymphoma as well as orphan drug designation in the United States and Europe for both Hodgkin lymphoma and anaplastic large cell lymphoma (ALCL).

Brentuximab Vedotin Phase I Clinical Trials

In a phase I dose-escalation study, 45 patients received doses of brentuximab vedotin every three weeks, ranging from 0.1 milligrams per kilogram (mg/kg) to 3.6 mg/kg. Among 28 evaluable Hodgkin lymphoma and systemic ALCL patients treated at doses of 1.2 mg/kg and higher, the overall response rate was 54 percent based on investigator assessment, compared to 57 percent based on independent review. At the higher dose levels, 39 percent of patients achieved a complete response based on investigator assessment, compared to 32 percent based on independent review. The median duration of response was at least 7.3 months.

The company is also conducting an ongoing phase I dose-escalation trial of brentuximab vedotin administered weekly to patients with Hodgkin lymphoma or systemic ALCL. Interim data have shown that out of 20 evaluable patients treated at doses of 0.8 mg/kg and higher, 60 percent achieved an objective response, including 50 percent with complete responses. Across all dose levels, 81 percent of patients achieved tumor reductions.

In both phase I clinical trials, brentuximab vedotin has been generally well tolerated. The majority of adverse events were Grade 1 and 2, with the most common being fatigue, fever, peripheral neuropathy, diarrhea and nausea.

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in targeted cell-killing.

Seattle Genetics is also conducting a single-agent phase II study of brentuximab vedotin in relapsed and refractory systemic ALCL, as well as a phase II study evaluating the potential for retreatment with brentuximab vedotin in patients who have relapsed after discontinuing previous brentuximab vedotin therapy.

Resolvyx Announces Positive Data From Phase 2 Clinical Trial Of The Resolvin RX-10045 In Patients With Dry Eye Syndrome

2009-08-26T02:29:00.000-07:00

Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, announced positive data from a Phase 2 clinical study evaluating RX-10045, a resolvin administered as a topical eye drop for the treatment of patients with chronic dry eye syndrome. In this 28-day, randomized, placebo-controlled, 232-patient trial, RX-10045 produced dose-dependent, statistically significant improvement on the primary endpoints for both the signs and symptoms of dry eye, and was generally shown to be safe and well tolerated. These Phase 2 results represent the first demonstration of clinical efficacy for the novel class of resolvin compounds and suggest that resolvins have the potential to treat a broad range of inflammatory diseases.

"There is an urgent need for new treatment options in dry eye and the results of this Phase 2 study are as strong as any I have seen," said Stephen Pflugfelder, MD, an expert in dry eye at Baylor College of Medicine. "Based both on these clinical results and on its unique mode of action, I am confident that RX-10045 can be an important new treatment modality for these patients."

The 28-day, randomized, multi-center, placebo-controlled study in 232 patients with moderate dry eye patients was designed to evaluate the safety, tolerability and efficacy of RX-10045 administered twice daily. The Phase 2 study examined three doses of RX-10045 and utilized a controlled adverse environment (CAE) to measure corneal staining in a stressful drying environment, as well as daily patient diaries using a standard visual analog scale to assess symptom improvement over the course of the study.

RX-10045 produced a significant dose-dependent improvement from baseline in symptoms recorded in daily patient diaries. The improvement was observed across all symptoms evaluated in the study, including dryness, stinging, burning, grittiness, ocular discomfort and the composite of each patient's most severe symptom (Worst Symptom Score). RX-10045 was superior to placebo on the primary symptomatic endpoint of Worst Symptom Score (p < 0.02), as well as on several individual symptoms. The onset of symptom relief occurred within the first week of treatment, and symptoms continued to improve over the course of the 28-day study, suggesting the potential for even greater benefit with longer treatment durations.

"I am very encouraged by the symptom relief achieved with RX-10045," said Ira Udell, M.D., Chairman of the Department of Ophthalmology at the North Shore-Long Island Jewish Health System and Professor of Ophthalmology and Visual Sciences, Albert Einstein College of Medicine. "Symptomatic improvement is what really matters to patients."

RX-10045 also produced a 75% reduction from baseline in CAE-induced staining of the central cornea (p < 0.00001), the primary sign endpoint in the study. This improvement was greater than that observed for placebo, the difference approaching statistical significance (p = 0.11). RX-10045 also produced a significant improvement in CAE-induced staining in the inferior cornea and in the composite of central and inferior cornea, which also approached statistical significance over placebo (p = 0.09).

"We are very enthusiastic about the results of this Phase 2 study which, in only a 28-day study, achieved what we believe is unprecedented dose-dependent improvement in the symptoms of dry eye, as well as strong improvement in the signs of dry eye. The results of this study will help Resolvyx design the pivotal trials for RX-10045, which are currently targeted to begin in the first half of 2010," said Greg Weinhoff, Executive Chairman of Resolvyx. "In addition to demonstrating the potential of RX-10045 to treat dry eye patients, this study also shows the potential of the entire resolvin class to treat a range of inflammatory diseases."

Resolvyx is also currently conducting a Phase 1 study with a second resolvin, RX-10001, an orally-administered drug candidate for the treatment of systemic inflammatory diseases such as asthma, inflammatory bowel disease and other inflammatory diseases.

About RX-10045

RX-10045 is Resolvyx's lead resolvin therapeutic, and is a synthetic analog of RvE1, a naturally occurring resolvin. RX-10045 has been shown to have potent anti-inflammatory and cell-survival benefits in laboratory testing. In preclinical studies, RX-10045 was highly effective in preventing signs of dry eye, including decreasing corneal inflammation, reducing corneal epithelial damage, preventing loss of goblet cells (cells that play an important role in maintaining tear film integrity) and improving tear volume. In addition, those studies demonstrated that RX-10045 potently inhibited the release of several key pro-inflammatory mediators from corneal epithelial cells and accelerated corneal tissue repair with an effect level comparable to that seen with epidermal growth factor, the most potent previously-known mediator of corneal tissue repair. RX-10045 is formulated as a clear, aqueous, preservative-free solution for ocular administration.

About Dry Eye Syndrome

Dry eye syndrome is one of the most common problems treated by eye physicians; an estimated 25-30 million Americans suffer from dry eye and the worldwide prevalence closely parallels that of the United States. Dry eye is a chronic, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Dry eye can make it more difficult to perform some visual activities for an extended period of time, and it can decrease tolerance for dry environments.

CDC Drafting Recommendation Of Routine Circumcision For Male Infants To Prevent Spread Of HIV

2009-08-26T02:25:00.000-07:00

The Centers for Disease Control and Prevention is drafting a formal recommendation that all male infants born in the U.S. be circumcised as a way to reduce the spread of HIV/AIDS, the New York Times reports. Recent studies have shown that in African countries circumcision reduces a man's risk of infection by 50%; however, those studies focused on heterosexual men who are at a high risk of contracting HIV from female partners. The procedure does not seem to protect men who have sex with men -- the population at greatest risk of infection in the U.S. It is unclear whether male circumcision reduces the risk for women, experts say. "There's mixed data on that," according to Peter Kilmarx, chief of epidemiology for the division of HIV/AIDS prevention at CDC. He added, "If we have a partially successful intervention for men, it will ultimately lower the prevalence of HIV in the population, and ultimately lower the risk to women."

The recommendation is expected to be released by the end of the year, but the issue already has generated controversy. Critics contend that the procedure subjects male infants to medically unnecessary surgery without their consent, while proponents argue that any measure that can reduce HIV infection rates should be taken under consideration. About 79% of adult men in the U.S. are circumcised. The Times reports that rates have fallen in recent years in part because the American Academy of Pediatrics does not endorse routine circumcision. AAP's policy states that circumcision is "not essential to the child's current well-being." As a result, many state Medicaid programs do not cover the operation, the Times reports. However, AAP is revising its guidelines and is expected to replace the neutral tone with a policy stating that circumcision has health benefits even beyond HIV prevention, such as reducing urinary tract infections in infants, according to Michael Brady, an AAP consultant.

Kilmarx said, "We have a significant HIV epidemic in this country, and we really need to look carefully at any potential intervention that could be another tool in the toolbox we use to address the epidemic." He added, "What we've heard from our consultants is that there would be a benefit for infants from infant circumcision, and that the benefits outweigh the risks." Still, according to Kilmarx and other public health officials, the benefits of such preventive measures would be muted in the U.S. compared with

50 Percent Of Healthcare Workers In Hong Kong Refuse To Get The Swine Flu Vaccine

2009-08-26T02:18:00.000-07:00

Research just published on bmj.com reports that about half of healthcare workers surveyed in Hong Kong say they would not be vaccinated against swine flu because of fears of side effects and doubts about effectiveness.

Still, the authors underline that vaccination is one of the most effective ways to reduce illness and death linked with pandemic flu. They believe that the benefits highly compensate for any possible risks.

The results of the research are unexpected, according to the authors, given SARS had such a huge impact in Hong Kong. Also, the study was underway at the same time as the World Health Organization (WHO) escalated its alert for swine flu to phase 5.

The results are comparable to a recent UK poll of almost 1,500 Nursing Times readers. It revealed that 30 percent of nurses said they would not have the swine flu vaccine.

The study documents that practically all countries with a pandemic flu plan intend to vaccinate healthcare workers as a priority group in order to protect the essential health infrastructure of their countries. However, this policy will only be successful if there is a high uptake of the vaccine.

Given the results of this study, lead author Professor Paul Chan from the Chinese University of Hong Kong mentions that a campaign to promote vaccination among healthcare workers is required.

Over 8,500 doctors, nurses, and related health professionals were surveyed. All were working at 31 hospital departments of internal medicine, pediatrics, and emergency medicine in Hong Kong.

Participants were initially surveyed from January to March 2009. This was when the WHO influenza pandemic alert was at phase 3. Then they were surveyed again in May 2009. At that point, the WHO raised its pandemic alert to phase 5 and it was the first time participants were specifically asked if they were willing to be vaccinated against swine flu. There was a response rate of 46.6 percent for the first survey and 48 percent for the second.

About 28 percent of respondents in the initial survey said they would be willing to be vaccinated against avian flu (H5N1).Interestingly, the authors explain, "no significant changes in the level of intention to accept pre-pandemic H5N1 vaccine were observed, despite the escalation to phase 5 because of the wide spread of H1N1 virus (swine flu)."

When the WHO alert level was at phase 5, 47.9 percent of respondents said they would be willing to be vaccinated against swine flu (H1N1).

The most frequent reasons for an intention to accept were:
• "wish to be protected"
• "following health authority's advice"

The most common reasons for refusal were:
• "worry about side effects"
• "query on the efficacy of the vaccine"
• "simply did not want the vaccine"
People who said they would accept the swine flu vaccination tended to be younger. They usually had received the seasonal flu vaccine in 2008-9 and feared they were more likely to get swine flu.

The authors write in conclusion: "To our knowledge, this is the largest study conducted to assess the willingness of healthcare workers to accept pre-pandemic influenza vaccination, and it provides important information on barriers to vaccination. Campaigns to promote vaccination should consider addressing the knowledge gap of staff and the specific target groups for intervention."

In an associated editorial, Rachel Jordan from the University of Birmingham and Andrew Hayward from the UCL Centre for Infectious Disease Epidemiology, emphasize that vaccination for healthcare workers is vital for their own protection and the safety of their patients. It could be of assistance to keep the NHS functioning at full capacity during the swine flu pandemic.

They claim that education and promotional campaigns alone have not been sufficient to convince healthcare workers to get vaccinated, "but the additional use of convenient mobile systems, monitoring and feedback systems, and the use of "opt-out" systems (where healthcare workers need to indicate their reasons for not accepting the vaccine) show promise."

30% of nurses 'don't want' flu jab

2009 H1N1 Flu Outbreak Map

2009-07-09T16:26:00.001-07:00

2009 H1N1 Flu Outbreak Map

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Swine Flu: Top 20 Questions and Answers

2009-07-09T16:23:00.000-07:00

Rumors are rife as the swine flu theme evolves. Here are twenty questions answered by Charles Ericsson M.D., Prof. Internal Medicine, Director of Travel Medicine, University of Texas Medical School, and Robert Emery DrPH, VP Safety, Health, Environment & Risk Management, UT Health Science Center, and Associate Prof. at the UT School of Public Health.

1. Are swine flu symptoms different from normal human flu?

They are similar. Swine flu is more likely to include diarrhea and vomiting, as well as the respiratory symptoms that come with typical seasonal human flu. Symptoms include:

* Chills
* Cough
* Fatigue
* Fever (greater than 100°F or 37.8°C)
* Headache and body aches
* Sore throat
* Stuffy nose

For information on what swine flu is, please see our what is swine flu? article.

2. How would I know I had swine flu if I had some symptoms?

You wouldn't, neither would your doctor. A respiratory specimen would have to be taken within the first four to five days. The specimen would be sent to a lab, which in the USA would be a CDC lab.

Authorities and experts still do not know why symptoms have been worse in Mexico than in the USA, Canada and other countries.

The important point is to call your doctor if you think you have the flu. Prescription anti-viral drugs such as TamiFlu or Relenza can be called in by your doctor. Unless you are:

* exceptionally ill with flu-like symptoms
* chronically ill
* immune-suppressed
* quite elderly
* or have a very young child, under age 2

It is best not to report to a hospital, as you could risk spreading the disease. Call your doctor and do what he tells you.

3. How long are infected people contagious?

An adult is usually contagious as long as they have symptoms - usually up to seven days following the beginning of the illness. The "shedding stage" of the virus is during the first 4-5 days of illness. Children can be considered contagious longer, up to 10 days. The initial incubation period is 24-48 hours.

4. What medications are there?

There is Tamiflu or Relenza - both have shown to be effective against these recently reported strains of swine flu. There are four anti-viral drugs altogether that are commonly used to treat various strains of flu.

5. Do these medicines prevent me from catching swine flu?

That is not currently advised. Preventative medication might be advisable for very special circumstances where a person had to expose themselves to potentially ill people during an epidemic (which we do not yet have here). Such people might include ER workers. An outbreak in a nursing home, for instance, might lead to protecting all the other residents with a drug like TamiFlu.

As the coverage time is limited, the preventative use of anti-viral medications is not advised for the general public.

Do not confuse OTC (over-the-counter) cold and flu preparations for anti-flu medications that you can only get with a prescription.

6. Do children and adults have the same symptoms?

Symptoms are similar. However, the signs of potentially life-threatening complications are not. The CDC advises those with these symptoms to seek emergency care immediately:

* Being extremely irritable
* Bluish skin color
* Rapid breathing or trouble breathing
* Fever with a skin rash
* Not drinking enough liquids
* Not waking up or interacting

Emergency warning signs in adults are:

* Confusion
* Difficulty breathing or shortness of breath
* Pain or pressure in the chest or abdomen
* Severe or persistent vomiting
* Sudden dizziness

7. Are there any swine flu vaccines?

Not currently. Authorities, such as the CDC in the USA are considering adding the current swine flu strain to next year's vaccine.

8. If I took the swine flu vaccine in the swine flu scare during the 70s, would that protect me now? Will this year's flu shot offer me any additional protection?

Nobody knows whether protection may be full, partial, or not at all. The current swine flu strain also has avian flu components. The avian flu component is not from the deadly bird flu strain.

9. Can I catch it from pigs?

No, you can only catch this strain from other humans. It is a mutated pig virus.

10. Can I catch it from eating pork meat and pork products?

No. Swine flu is not transmitted by the food you consume - it is not a foodborne illness. All pork food products are safe to consume - as long as they are prepared properly. The virus dies at 160 degrees Fahrenheit.

Swine flu is transmitted in the same way normal flu is - through airborne droplets form a sick person's cough or sneeze

11. How does it cross from a pig to a human?

The swine virus mutates so that it can infect humans and be spread by humans.

12. Can it kill me?

Deaths have been reported from the Mexico City outbreak. So far the cases in the US have been mild and there have been no deaths as of this writing (Monday, April 27) We do not know all the factors geographically and demographically that may contribute to the mildness or severity of this flu. But, like seasonal flu, there is the potential for serious outcomes.

13. Why the big concern if the regular flu kills 35,000 people a year, which is why we are all encouraged to get a flu shot?

This is a new flu strain that our bodies have not been exposed to before. The flu strains that the CDC creates a vaccine for each year all have the potential to cause great harm, especially in elderly, pediatric and chronically ill patients. This particular flu strain has struck seemingly healthy, young adults, with some resulting in death in Mexico. It also appears to be quite contagious. We will know more about this strain in the coming days.

14. How is it different from avian (bird) flu?

Avian flu so far has had difficulty infecting humans unless they are exposed intensely to birds, because the virus has not mutated in a way that makes it transmissible by humans to other humans. This virus has origins genetically from both pigs and birds, and the big difference from the avian flu is that this swine virus can be transmitted readily from human to human.

15. Is this just another scare that will go away like bird flu?

Bird flu is a theoretical threat and will need a mutation to be able to be transmitted among humans to become a serious threat. The present "swine/avian" virus clearly has already caused a major outbreak in Mexico City and San Luis Potosi, Mexico and has spread to places in the US (California, New York, Texas, Kansas and Ohio). What is not clear yet is whether this virus will result in a so-called pandemic worldwide spread with major outbreaks--or whether it will fizzle out. But, even if it fizzles out, there is logical concern that it might re-emerge next flu season.

16. Should I cancel my vacation to Mexico?

At this writing, the situation is very fluid, changeable. I suggest checking frequently with the CDC Web site for possible Travel Alerts. I probably would not travel to Mexico City for a vacation that could easily be rescheduled, if for no other reason than the city has tried to limit access to crowded or public places where transmission might be facilitated. That does not sound like a very pleasant vacation to me!

Having said that, there are more than 4,000 flights to Mexico from the US and none have been cancelled as of this writing. However, some international airports in Europe and Asia are stepping up precautions and issuing alerts. Again, check the CDC's Travel Alerts page.

17. What if I'm on a plane? Should I wear a mask?

Not necessary. The air on a plane is filtered. Transmission might occur if someone sitting close to you coughs or sneezes on you. The newer designs of aircraft airflow keep the air in a top-down flow, not forced air from front to back. However, if you do have a respiratory illness, it might be best not to travel.

18. How long does the germ live on surfaces, like on my desk if someone sneezes in my office?

Influenza virus survives only minutes on inanimate objects or hands, so these are very inefficient ways to spread the illness. Influenza is most easily spread by droplets that come into contact with our mucus membranes such as when someone coughs or sneezes in our faces. If we shake hands with an infected person who has just wiped their nose and then we rather quickly rub our nose or eyes with our own hand, then we could get the flu. So, good hand washing does play a role in diminishing the spread of the disease.

19. Other than hand washing and covering my mouth if I sneeze or cough, what can I do to take care of myself and others?

If you are ill, stay home. Control your sneezes and coughs. If you cough into your hand, remember the virus could be live on your hand at least for a few minutes, so wash your hands before touching anyone else. If you get symptoms suggesting the flu, call your doctor, who can call in a prescription for medication to treat the flu. Resist going to the doctor's office or a hospital ER for influenza symptoms unless you are seriously ill. You do not want to spread the disease to others.

20. What else can I do?

Keep in touch with the most recent CDC messages through the following links:
http://www.cdc.gov/swineflu/investigation.htm
http://www.cdc.gov/swineflu/general_info.htm
http://www.cdc.gov/swineflu/whatsnew.htm

Go to the sources of verifiable information such as WHO (World Health Organization) or the CDC.

Most important, be alert, not panicked.

"There is a huge difference between preparedness and paranoia", says Dr. Robert Emery, occupational health expert at the UT School of Public Health at Houston. "Although we're dealing with a new strain of flu, a set of universally applicable preventive measures exist that can be employed right away by everyone to help stop the spread of this disease"
Proper hand hygiene:
There's a right way and useless way to wash hands and wash away micro-organisms. The object is to break down the protective membranes of germs, dislodge them from your hands and let them go down the drain. Plain soap in the right hands is strong stuff.

* Lather well with a bar of soap or squirt a coin size of liquid soap in the palm of your hand.

* Vigorously rub your hands together, soap up between your fingers, AND your wrists, front and back for 15 seconds. Sing the first chorus of any song you know and that'll take you through the 15 seconds.

* Rinse under warm, RUNNING water. Remember, the object is to dislodge germs. The force of water is key.

* Thoroughly dry your hands with a disposable towel or under the blower, again, rubbing your hands together.

* Discard the towel.

If you're using alcohol-based gels as hand cleansers:

Put a dime-sized amount in one hand:

* Vigorously rub your hands together and in between your fingers until the GEL IS DRY about 30 seconds.

* DO NOT touch your face!

Once your hands are clean, do not touch your face, nose, eyes or lips.

Rubbing your eyes and nose provides a freeway for micro-organisms and good breeding ground once they've arrived.

Cover your cough

If you must cough or sneeze, cover your mouth with a tissue, your sleeve or your hand. Throw the tissue away in a waste basket. Do not leave discarded tissues on your desk or other surfaces.

Then, wash you hands thoroughly.

The throw-it-away part is essential.

Micro-organisms live a life span from a few seconds to days on inanimate surfaces such as desks, table tops, faucets…tissues. If your tissues are scattered on your coffee table, they then are in contact with community surfaces. Both the tissues and the surface it sits on can spread germs to the person who touches the coffee table.

If you begin to feel ill: feverish, achy, have a dry, painful cough, sore throat, go home from school or work and call your health care provider for further instructions.

If you feel sick with flu-like symptoms and you care for the very young or the very elderly or the chronically ill, inform your health care provider when you call their office.

Total confirmed human cases of Swine Flu A(H1N1) infection, and total deaths, 3rd July, 2009 (Source CDC) by state

2009-07-09T16:21:00.000-07:00

# Alabama - 330 cases, 0 deaths
# Alaska - 60 cases - 0 deaths
# Arkansas - 42 cases - 0 deaths
# Arizona - 761 cases - 10 deaths
# California - 1985 cases - 21 deaths
# Colorado - 136 cases - 0 deaths
# Connecticut - 1247 cases - 6 deaths
# Delaware - 316 cases - 0 deaths
# Florida - 1302 cases - 5 deaths
# Georgia - 118 cases - 0 deaths
# Hawaii - 616 cases - 0 deaths
# Idaho - 92 cases - 0 deaths
# Illinois - 3166 cases - 13 deaths
# Indiana - 267 cases - 0 deaths
# Iowa - 92 cases - 0 deaths
# Kansas - 117 cases - 0 deaths

# Kentucky - 130 cases - 0 deaths
# Louisiana - 183 cases - 0 deaths
# Maine - 82 cases - 0 deaths
# Maryland - 591 cases - 1 death
# Massachusetts - 1308 cases - 3 deaths
# Michigan - 484 cases - 7 deaths
# Minnesota - 576 - 1 death
# Mississippi - 161 cases - 0 deaths
# Missouri - 65 cases - 1 death
# Montana - 67 cases - 0 deaths
# Nebraska - 111 cases - 0 deaths
# Nevada - 301 cases - 0 deaths
# New Hampshire - 224 cases - 0 deaths
# New Jersey - 1159 cases - 9 deaths
# New Mexico - 232 cases - 0 deaths
# New York - 2499 cases - 44 deaths
# North Carolina - 255 cases - 2 deaths
# North Dakota - 57 cases - 0 deaths
# Ohio - 120 cases - 1 death
# Oklahoma - 128 cases - 1 death
# Oregon - 366 cases - 4 deaths
# Pennsylvania - 1748 cases - 4 deaths
# Rhode Island - 158 cases - 1 death
# South Carolina - 160 cases - 0 deaths
# South Dakota - 29 cases - 0 deaths
# Tennessee - 174 cases - 0 deaths
# Texas - 3991 cases - 17 deaths
# Utah - 920 cases - 10 deaths
# Vermont - 49 cases - 0 deaths
# Virginia - 191 cases - 1 death
# Washington - 588 cases - 4 deaths
# Washington, D.C. - 33 cases - 0 deaths
# West Virginia - 154 cases - 0 deaths
# Wisconsin - 5861 cases - 4 death
# Wyoming - 81 cases - 0 deaths
Territories
# Puerto Rico - 18 cases - 0 deaths
# Virgin Islands - 1 case - 0 deaths

TOTAL - 33,902 cases - 170 deaths

33,902 Swine Flu A(H1N1) Cases Including 170 Deaths In USA

2009-07-09T16:18:00.000-07:00

The Centers for Disease Control and Prevention (CDC) informed in its weekly update on Friday evening, 3rd July, 2009, that the total number of confirmed human cases of swine flu A(H1N1) infection stands at 33,902, including 170 deaths

In a Swine Flu conference held today in Cancun, Mexico, the World Health Organization (WHO) warned that the virus' spread is now "unstoppable". The WHO added that swine flu infection cases are mostly mild, with the vast majority of people recovering unaided.

Health authorities in the UK predict that British infection numbers should exceed 100,000 by the end of this summer

Long term treatment with interferon (HALT-C) is huge disappointment

2009-03-28T04:56:00.000-07:00

Results of the Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis (HALT-C) trial—one of the most anticipated clinical trials in years— were highly disappointing. The multicenter study showed "without question that maintenance therapy with peginterferon does not prevent progression of liver disease among patients who have failed prior treatments," says James Everhart, MD, the National Institute of Health's HALT-C project scientist.1

HALT-C outcomes were death, liver cancer or liver failure, and/or cirrhosis. At the end of the study, 34.1% of the treated group and 33.8% of the control group had experienced at least one outcome. While patients in the treated group had significantly lower blood levels of the hepatitis C virus and improvement in liver inflammation, there was no major difference in rates of their primary outcomes.

Although the protocol did lower the "so-called necro-inflammatory score," it was not associated with any benefit, says John Lake, MD, director of the Liver Transplant Program, University of Minnesota, Minneapolis. "That was really surprising. They achieved what they wanted to achieve, but it didn't have the downstream effect they were looking for," he says.

Follicular Unit Extraction vs Older Methods of Hair Transplantation

2009-03-09T14:45:00.000-07:00

In the past, as the names of these earlier procedures indicate, undergoing a hair transplant was a painfully unpleasant process. Men with receding hairlines and balding scalps often resorted to the unnatural-looking, and often ridiculed, toupee to avoid the pain, slow healing, and scarring of a transplant.

Because of this, the hair transplant business was staggering in the late twentieth century. Surgeons knew that hair restoration techniques needed to evolve.

Thousands of bad comb-overs and strip incision scars later, the new technique that hair restoration surgeons were waiting for was finally perfected. The hair transplant community eventually embraced follicular unit extraction (FUE). Surgeons praised the method and potential patients were curious about it.

But what exactly is follicular unit extraction? And is it really more effective and beneficial than older methods of hair transplantation?

Follicular unit extraction involves the removal of small groups of hair follicles (usually between one and four) from the donor site and their reinsertion into the receptor site. These small grafts allow for equal distribution of hair in the balding area of the scalp and produce more natural-looking results. In fact, once the receptor site has completely healed, it is virtually impossible to detect that any sort of hair transplant procedure has taken place.

The differences between FUE and the older methods of transplantation are noteworthy.

Firstly, the FUE procedure is quicker and less painful than any other hair restoration technique. FUE is performed with a punch-like scalpel that cuts the skin around the follicle. This facilitates the removal of about one to four follicles from the donor area at the same time. Also, the advanced method of follicular perforation� allows the surgeon to make a shallow punch on the surrounding tissue, ensuring that the graft be released from the tissue with minimum traction and with better ease. The extracted follicles (called grafts) are then inserted into small slits that have been cut in the recipient area. These slits do not need suturing, heal quickly, and are completely undetectable once the new hair begins to grow in about seven to ten days.

Secondly, FUE is beneficial because the recovery process is much faster and less painful. In most patients, the grafts become fully secure in about eight days after surgery and the surgical wound in the donor area usually heals within one to two weeks. Some discomfort may be present, but usually analgesics like Tylenol or codeine will help. Generally, normal activity may be resumed one to two weeks after the procedure. In older methods of hair restoration, bleeding, suturing, and bandaging were parts of the long and painful recovery process.

Thirdly, 100% of hair loss sufferers are candidates for FUE. In the past, hair restoration was not as widely available to every hair loss sufferer as it is today. There were various criteria that each candidate had to meet to be eligible for a hair transplant. Such criteria included the patient's age, color and texture of hair, skin complexion, amount of donor hair available, and future hair loss projections. However, because the methods involved with follicular unit extraction are so advanced, such criteria are not much of a concern. For example, the amount of donor hair on the head is not an issue when determining candidacy because the procedure allows for the extraction of hair from other parts of the body.

Fourthly, the incidence of complication during the FUE procedure is lower than with other transplantation methods. In a study, published by Dr. Masumi Inaba, of over 150 patients treated with FUE, researchers found that patients suffered only from mild discomfort from sitting still for several hours at a time. Furthermore, only four out of the 150 patients experienced donor area shock, while two more patients experienced a more limited variety of patchy circular alopecia (hair loss). Nevertheless, all patients made full recoveries of hair transplant within five weeks.

Lastly, FUE patients recover without visible scars in the donor or recipient area. Unlike previous methods, like strip incision, where an unattractive linear scar was exposed in the donor area, FUE does not leave ugly, unbearable scars on the head. Instead, the tiny slits that are cut in the recipient area are conveniently hidden by new hair. The final result of FUE in all patients is that of a seamless, natural, healthy-looking head of hair.

For all those who are suffering from hair loss and are searching for the best method of restoring their youth, follicular unit extraction should be considered. It is a hair restoration method that discards the use of the painful linear donor incision and regards 100% of hair loss patients as proper candidates for the procedure. It is widely predicted that within the coming years, follicular unit extraction will make further advancements and become the method of choice for every hair restoration surgeon and patient.

The Impact Of Obesity On The Diagnosis Of Prostate Cancer Using A Modern Extended Biopsy Scheme

2009-02-02T05:05:00.000-08:00

UroToday.com - Studies associating obesity and prostate cancer (CaP) are varied. In the February 2009 edition of the Journal of Urology, Dr. Raj Pruthi and colleagues reported on the impact of obesity in the detection of CaP. The study is a single institution series of 500 men with an increased or increasing PSA or abnormal DRE who underwent transrectal ultrasound guided biopsy of the prostate. All men had an extended 10 to 12 core biopsy, which makes this report relevant to present day standards.

Clinical and pathologic parameters were evaluated. For the purpose of this study, body mass index (BMI) was categorized into non-obese (<30kg/m2) and obese (>30 kg/m2). This differs from many studies, in which the non-obese category would typically be further separated into normal (<25 kg/m2) and overweight (25-30 kg/m2).

The mean patient age was 63.4 years, mean BMI was 27.6 kg/m2, median PSA was 6.5ng/ml, and mean prostate volume was 50.4cc. Of the participants, 26% were considered obese. Forty-five percent had CaP on biopsy, but there was no difference in mean BMI between those with a positive vs. a negative biopsy. Obese men were younger, had larger prostates, were less likely to have an abnormality on DRE, and less likely to have a positive biopsy by chi square analysis. In multivariate analysis controlling for age, PSA and prostate volume, there was not a difference between non-obesity and obesity for detection of CaP. Also, modeling for high-grade Gleason score demonstrated no difference for BMI. In patients with negative biopsies, obese men had larger prostate volumes (p=0.033). The investigators did a subset analysis on 367 men with a PSA <10ng/ml and found no differences in the biopsy rates of obese vs. non-obese men.

While previous studies have demonstrated a higher CaP detection rate in obese patients by using an extended prostate biopsy scheme, this study did not find that obese men had a higher detection rate of CaP in multivariate analysis.

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Effect Of Male Circumcision On The Prevalence Of High-Risk Human Papillomavirus In Young Men

2009-02-02T05:04:00.000-08:00

UroToday.com - Human papillomavirus is the most commonly sexually transmitted infection in the United States. The American Cancer Society estimates that about 11,000 women in the United States will be diagnosed with invasive cervical cancer annually and almost 4,000 will die from this disease. This study done by Dr. Bertran Auvert et al. investigated the association between male circumcision and the prevalence of human papillomavirus among young men.

This study utilized data from a trial conducted in Orange Farm, South Africa among men between the ages of 18-24 years. Urethral swabs were collected from participants in the intervention who were circumcised and the controls who were uncircumcised and were coming in for scheduled follow-up visits. Polymerase chain reactions were performed for analysis of human papillomavirus.

The prevalence of human papillomavirus was 14.8% in those that were circumcised and 22.3% in those who were uncircumcised. Controlling for other confounding variables such as ethnic group, age, education, sexual behavior [including condom use], marital status, and HIV showed no effect on the results.

The group concluded that this was the first randomized controlled trial to show a reduction in the prevalence of urethral human papillomavirus infection after circumcision. It correlates with the finding that women with a circumcised partner are at a lower risk of cervical cancer than women with uncircumcised partners.

Since human papillomavirus is a virus, HPV vaccines are being investigated. Currently, Gardasil is currently being administered for helping HPV prevention. Currently, only women are being treated with the HPV vaccine, but since both men and women are carriers of human papillomavirus, the possible benefits and efficacy of vaccinating men are currently being studied.

Gold Spheres Seek And Destroy Melanoma Cells

2009-02-02T04:54:00.000-08:00

US researchers armed tiny hollow gold spheres with a highly targeted peptide so they could hunt down and get deep inside melanoma cells and then destroy them using heat converted from infra red light.

The research was the work of scientists from the University of Texas MD Anderson Cancer Center and is published in the 1 February issue of Clinical Cancer Research.

Senior author Dr Chun Li, a professor in MD Anderson's Department of Experimental Diagnostic Imaging said:

"Active targeting of nanoparticles to tumors is the holy grail of therapeutic nanotechnology for cancer."

Li said he and his team were getting closer to that goal.

Co-author, Dr Jim Zhang professor in the University of California-Santa Cruz Department of Chemistry developed the tiny gold spheres, 40 to 50 nanometres in diameter. Their hollowness allows them to penetrate cells, and they have a strong but narrow and tunable ability to absorb light at the visible and near-infrared end of the spectrum, something other metal nanoparticles don't have.

Li, Zhang and colleagues used the minimally invasive treatment on live lab mice. The method is called photothermal ablation, where target tissue is destroyed by irradatiating the target area in which the thermal material, in this case nanoparticles, but sometimes optical fibres are used, is irradiated with light which is turned into heat to destroy the surrounding tissue.

However, melanomas are not easy to treat in this way because it is hard to get the targetting metal particles to differentiate between healthy and cancerous tissue. Li and colleagues were able to do this by embedding a peptide, a small molecule made up of amino acids, in the gold nanospheres. The peptide was highly targeted, it would only bind to the melanocortin type 1 receptor, which is overly abundant in melanoma cells.

First in Cultured Cells

Li and colleagues first treated the melonoma cells in culture. When they switched on the infra-red light, the nanospheres absorbed the light and converted it to heat, which burned off the tumors (they literally got "cooked"). Infra-red light penetrates deeper into tissue than visible or ultraviolet light.

They found that the actively targeted gold nanospheres did more than eight times more damage to the melanoma tumors than the same nanospheres that were not actively targeted.

It is possible to treat cancer just using the targeted light on its own (via embedded optical fibres), but as already mentioned, melanomas are much harder because they are surrounded by healthy tissue. With the highly targeted gold nanospheres as a way to focus the light, Li and colleagues were able to use 12 per cent of the dose required, which is more likely to spare surrounding healthy tissue.

The injected nanospheres are small enough to get right inside the melanoma tumor and attach themselves to the cancer cells' blood supply. Using fluorescent tagging on the nanospheres that they tested on the cultured melanoma cells, Li and Zhang and colleagues were able to show that the targeted nanospheres were drawn right into the cells through the cell membrane while the untargeted ones were not.

When they irradiated the treated cultures, the researchers found that most cells containing the targeted nanospheres died, and nearly all those left where damaged beyond repair. But this did not happen with the untargeted nanospheres, only a very small fraction of cells treated with them died.

Also, irradiation with near-infrared light alone, or treatment with nanospheres alone without light, had no effect on the cells.

It was therefore the combination of highly targeted nanospheres and the irradiation that had the maximum effect of killing targeted cancer cells.

Then in Live Mice

In the live mice, fluorescent tagging showed that the untargeted nanospheres gathered near the tumor's blood vessels whereas the targeted ones penetrated into the tumor and were found spread around inside it.

A common problem with using nanoparticles is that the body sends foreign matter to the liver and spleen for destruction. Most of the targeted nanospheres stayed in the tumor, with some found in the liver and spleen. But most of the untargeted nanospheres gathered in the spleen, then the liver and then the tumor. The researchers said this showed the importance of targeting the nanospheres more selectively.

Li said:

"There are many biological barriers to effective use of nanoparticles, with the liver and spleen being the most important."

When they irradiated the mice with the near infrared light, those that had been injected with targeted nanospheres, had nearly 66 per cent of their tumors destroyed. This compared with only 7.9 per cent tumor destruction in the mice that had only been injected with untargeted nanospheres.

The researchers were able to measure the tumors by using tagged glucose (F-18-labelled). This shows up on a PET scan. Tumors treated with targeted nanospheres did not light up very much, showing there was little metabolized tagged glucose in them.

Clinical Implications

While the findings of this study show implications for the treatment of melanomas, Li said they were proof of principle for other cancers too.

"Receptors common to other cancers can also be targeted by a peptide-guided hollow gold nanosphere," said Li.

"We've also shown that non-invasive PET can monitor early response to treatment," he added, explaining that the hollow nanospheres are also made with pure gold, which has a long history of safe use in medicine with few side effects.

The National Cancer Institute Alliance for Nanotechnology in Cancer, the John S. Dunn Foundation, and the U.S. Department of Defense paid for the study.

Co-authors with Zhang, and Li were: Wei Lu (first author), Chiyi Xiong, Guodong Zhang, Qian Huang and Rui Zhang, all from MD Anderson's Department of Experimental Diagnostic Imaging.

Obama Set To Lift Restrictions On Stem Cell Research

2009-02-02T04:52:00.000-08:00

Researchers in Texas and throughout America are eagerly waiting to hear that President Barack Obama has lifted restrictions on using human embryonic stem cells in research, an event the US media is expecting to happen later this week.

According to a report in the Houston Chronicle, Baylor College of Medicine and the University of Texas Health Science Center at Houston are both centres of excellence in stem cell research, and while most of their work has been focusing on adult stem cells, they anticipate a huge expansion of activity when Obama overturns the policy of former President George W Bush.

Unlike adult stem cell research that uses cells harvested from tissue taken from people without harming them, embryonic stem cells are taken from 5- day old embryos that have to be destroyed in the process, putting the issue at the centre of a heated ethical and political debate.

Baylor Professor Bill Brinkley, a molecular and cellular biologist, told the Houston Chronicle that lifting the restriction will make embryonic stem cell research mainstream:

"Most every lab will take advantage of it," said Baylor.

Embryonic stem cells can become any of the 220 types of cell in the body. Scientists predict they will one day be used to make new tissue to replace old and diseased nerves, bones, muscles, heart tissue, and blood vessels. For example, animal studies have already shown it may be possible to create new brain cells, muscle tissue, and pancreatic cells, with potential for treating Parkinson's, muscular dsytrophy and diabetes, respectively.

In 2001, Bush put the brakes on embryonic stem cell research by restricting it to existing cell lines only (ie no more harvesting from embryos). There were only about 20 or so of these in existence at the time and their condition was said to be poor and not very useful for clinical work. Many scientists felt this severely hampered their ability to do serious research in the field.

During his election campaign, Obama promised to lift Bush's restriction to allow scientists to use stem cells harvested from embryos that would otherwise be discarded in fertility clinics. He is planning to do this after he has finished working on the plans to revive the economy, said the Chronicle. A legal bill would still be needed to ratify the policy.

Some say Bush wanted to slow down embryonic stem cell research to make scientists focus on adult stem cells.

Adult stem cells are not as versatile as embryonic stem cells: their potential tends to be restricted to the type of tissue they originated from, although some recent experiments have shown they may be more plastic than first thought and it might be possible to make them behave more like embryonic stem cells.

However, scientists are nervous about using the adult stem cell approach because it involves using genetically engineered viruses which can cause tumors.

Paul Simmons, an adult stem cell researcher and director of University of Texas Houston's Center for Stem Cell Research, told the Chronilce that the technique was far from perfect and doubts whether it will eventually be as good as using embryonic stem cells. Perhaps in the end, scientists will find that adult stem cells are good for some things and embryonic stem cells are better for others, he said.

Scientists at the University of California at Irvine have already developed a therapy using embryonic stem cells that made paralyzed rats walk again. Earlier this month they were given federal approval to go ahead and test their approach in humans, the first embryonic stem cell treatment to be tested in humans.

According to the Houston Chronicle, research centres in Texas are queueing up to put in grant applications to pursue research in using embryonic stem cells to treat Parkinson's, lung disease, and making cartilage to replace worn out joints. If the state legislature supports Obama's expected move, experts predict Texas will become a leader in the field of embryonic stem cell research, said the paper.

FDA Issues A Complete Response Letter For Lilly's Olanzapine LAI For Treatment Of Schizophrenia In Adults

2009-01-08T04:35:00.000-08:00

Eli Lilly and Company (NYSE: LLY) announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults. Lilly is continuing to work with the agency on the new drug application (NDA).

The FDA does not require any additional clinical trials for the continued review of the NDA. Per the agency's request, Lilly is preparing a proposed Risk Evaluation and Mitigation Strategy (REMS), which will be submitted in the near future.

"We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness," said Todd Durell, M.D., associate medical director for U.S. neuroscience for Lilly.

This treatment has been approved for use in the European Union and New Zealand under the trade name Zypadhera(TM). Independent regulatory reviews are ongoing in other countries.

About Long-acting Injectable Antipsychotic Medications

The World Federation of Societies of Biological Psychiatry (WFSBP) guidelines state that poor or partial treatment compliance is a major problem in the long-term treatment of schizophrenia. Depot formulations should be considered as a treatment option if it is determined that a depot formulation is necessary to help with compliance.(1)

By administering long-acting medications, healthcare professionals know when patients have received their medication and can immediately detect non- adherence when a patient fails to return for a scheduled injection.(2) Different from both oral and injected short-acting formulations, long-acting formulations of antipsychotics allow for stable concentrations of the active drug to remain at a therapeutic range for an extended period of time.(3)

About Schizophrenia

Schizophrenia is a severe and debilitating illness with such symptoms as delusions (false beliefs that cannot be corrected by reason), hallucinations (usually in the form of non-existent voices or visions), disorganized speech and severe disorganized or catatonic behavior. These signs and symptoms are associated with marked social or occupational dysfunction. Features of schizophrenia consist of characteristic signs and symptoms that have been present for a significant portion of time during a one-month period, with some signs of the disorder persisting for at least six months.(4) In addition to these symptoms, patients with schizophrenia are at greater risk for medical comorbidities than the general population.

More U.S. Residents Seeking To Participate In Paid Clinical Trials As Economy Weakens

2009-01-08T04:32:00.000-08:00

Research centers across the U.S. and those familiar with the prescription drug industry say that, as the U.S. economy weakens, more people are seeking to participate in paid clinical trials of new drugs, the AP/Boston Globe reports. Kenneth Kaitin, director of the Tufts Center for the Study of Drug Development, said over the past several years, declining interest among U.S. residents to participate in drug studies led some drug developers to conduct trials in other countries, such as India and China. Ken Getz, founder of the Center for Information & Study on Clinical Research Participation, said there already is evidence that the outsourcing trend is reversing, particularly for early-phase trials, and the recession and changes to the regulatory process have helped start the reversal.

According to the AP/Globe, clinical trials can pay participants "upward of thousands of dollars in exchange for a few weekends or more committed to testing new drugs." Steve Peck, director of operations at Nebraska-based Qualia Clinical Services, said the pool of potential participants also has become more diverse, and the company's database of participants has nearly doubled from 9,000 one year ago to about 16,000 currently.

The AP/Globe reports that as a result of the weakening economy, there also has been an increase in plasma donations. According to John Penrod, vice president of the Source division of the Plasma Protein Therapeutics Association, plasma donations topped 15 million in 2007, up from 10 million in 2005. Penrod said that reasons for the increase trend vary by region but noted the importance of compensation in generating enough of a plasma supply for worldwide use (Ortiz, AP/Boston Globe, 1/5).

Antioxidants Offer Pain Relief In Patients With Chronic Pancreatitis

2009-01-06T13:26:00.000-08:00

Antioxidant supplementation was found to be effective in relieving pain and reducing levels of oxidative stress in patients with chronic pancreatitis (CP), reports a new study in Gastroenterology. CP is a progressive inflammatory disease of the pancreas in which patients experience abdominal pain (in early stage) and diabetes and maldigestion (in late stage). Pain is the major problem in 90 percent of patients with CP and currently, there is no effective medical therapy for pain relief. Gastroenterology is the official journal of the American Gastroenterological Association (AGA) Institute.

In this placebo-controlled, double blind trial, 127 patients, ages 30.5+/-10.5, were assigned to placebo or antioxidant groups. After six months, the reduction in the number of painful days/month was significantly higher in the antioxidant group, compared with the placebo group (7.4±6.8 versus 3.2±4, respectively). The reduction in the number of analgesic tablets/month was also higher in the antioxidant group (10.5±11.8 versus 4.4±5.8, respectively). Furthermore, 32 percent and 13 percent of patients became pain free in the antioxidant and placebo groups, respectively; the beneficial effect of antioxidants on pain relief was noted early at three months.

"Abdominal pain, the predominant symptom in patients with CP, is difficult to treat. The main reason for a largely ineffective medical treatment is that the mechanism of pain in CP is not well understood," said Pramod Kumar Garg, MD, DM, of the All India Institute of Medical Sciences, New Delhi and lead author of the study. "We are encouraged by our findings, as significant improvement was noted with antioxidants in respect to all the parameters of pain in this study. In addition, reduction in pain resulted in fewer man-days lost, thus providing functional employment gain to the patients. The findings should spur further research in this exciting area."

There are two important implications of this study - the fact that measures of oxidative stress were increased initially and decreased subsequently after supplementation with antioxidants suggests that there is a state of heightened free radical mediated injury in CP, and that injury is reversible. Second, with regard to pain management, this trial showed that antioxidant therapy is effective for pain relief in patients with CP. This assumes significance since no effective medical therapy exists for pain relief for such patients.

Pancreatitis is inflammation of the pancreas that usually begins as a sudden attack and is often caused by gallstones, alcohol abuse or genetic mutations. Symptoms of pancreatitis start with a gradual or sudden severe pain in the center part of the upper abdomen going through to the back. Treatment often focuses on the nutritional and metabolic needs of the patient and on relieving pain. Most people with chronic pancreatitis have a good prognosis if they follow their treatment regimen. "Aside from medication, abstaining from alcohol and smoking are most important and key to halt the progression of CP," added Dr. Garg.

Immutep Announces Positive Interim Results In Phase I/II Chemoimmunotherapy Trial In Breast Cancer

2009-01-06T13:25:00.000-08:00

Immutep S.A. announced today interim results from its ongoing Phase I/II chemoimmunotherapy clinical trial in metastatic breast carcinoma. ImmuFact IMP321 was administered the day after weekly paclitaxel for six months. The interim results show a clinical response rate of 50 per cent compared to 25 per cent with paclitaxel alone. In addition, a robust immune response was observed in clinically-responding patients.

IMP321 is a first-in-class immunopotentiator that agonizes MHC class II molecules thereby stimulating antigen-presenting cells, such as dendritic cells and monocytes, leading to markedly improved cytotoxic CD8 T-cells responses against tumours.

Chemoimmunotherapy is a new approach to the treatment of cancer. Chemotherapy drugs induce tumour cell apoptosis and cause modulation of the immunological environment combined with a burst of tumour antigen release. The resulting T-cell immune response contributes to the regression of the tumour and, importantly, may seek out and destroy metastases. However, this initial immune response needs to be sustained and amplified by a T-cell booster that is non-toxic and can be given repeatedly, such as ImmuFact IMP321.

The design of the study is a multi-centre open-label fixed dose-escalation trial. One of the lead centre's main Principal Investigators, Maya Gutierrez, is coordinating the team carrying out the trial at the René Huguenin Cancer Centre, Saint Cloud, near Paris.

Patients receive 6 cycles of low-dose weekly paclitaxel at Day 1, Day 8 and Day 15 of a 4-week cycle as first line chemotherapy plus bi-weekly IMP321 administered the day after the paclitaxel to make a total of 12 injections of IMP321 over 24 weeks. Three dose levels of IMP321 are being studied in three cohorts of 8 patients each. The interim results are based on tumour regression under RECIST criteria in the first two cohorts of 16 patients out of the total of 24 compared to the historical control group which is the weekly paclitaxel arm of a recent randomised phase III study (N. Engl. J. Med. 2007; 357:2666-76). The improvement is statistically significant with a p-value of 0.03.

"Such sequential chemo- and then non-toxic immunotherapeutic combos may be a way to improve the response rate and/or consolidate or stabilize the partial tumour responses obtained with chemotherapy alone," said Dr Maya Gutierrez, Principal Investigator of this Phase I trial. "We are very pleased to be testing this innovative therapeutic approach at our Institute."

"Boosting the dendritic cell network when it is loaded with tumour antigens following chemotherapy with repeated injections of IMP321 is an effective way to amplify the cytotoxic CD8 T-cell responses observed in first-line chemotherapy," said Frédéric Triebel, Scientific & Medical Director of Immutep. "A similar approach will shortly be tested in the first trial of IMP321 in the USA in pancreatic cancer patients receiving first-line gemcitabine."

"These positive results have encouraged us to engage in discussions with potential partners over Immutep's plans for the advanced development stages of IMP321 as we continue to collect data from this study at the highest dose," added John Hawken, CEO.

For further information please visit the web-site http://www.immutep.com

Metastatic Breast Cancer and Chemoimmunotherapy

Metastatic breast cancer remains incurable. The failure of current approaches is generally attributed to the outgrowth of breast tumour cells that are inherently resistant to standard treatments. Manipulating the immune system to recognize and eradicate breast tumour cells is a highly attractive alternative approach to disease management. Active immunization offers multiple theoretical advantages over all other therapies, including low toxicity. The sustained antitumour effect due to immunological memory would obviate the requirement for prolonged, repetitive cycles of therapy.

The objective of chemo-immunotherapy is to amplify natural pre-existing T-cell responses specific for any known or unknown tumour antigen and to recruit and amplify new tumour-specific T-cell responses resulting from the use of cytotoxic drugs known to induce tumour cell apoptosis. The direct cytolytic effect of some cytotoxic drugs, such as paclitaxel, can enhance antigen presentation by inducing tumour cell apoptosis. This mechanism of therapeutic synergy has been shown with cyclophosphamide, doxorubicin, or paclitaxel when given with dendritic cell-based vaccines. Until 8 years ago, it was thought that the T-cell depletion caused by chemotherapy would make immunotherapy ineffective. However it has now been shown that, on the contrary, the vigorous T-cell repopulation following depletion can be directed against the tumour, the so-called "rebound" effect.

Soluble LAG-3 protein is a prognostic factor in breast cancer

ImmuFact IMP321 is closely related to the soluble form of the LAG-3 (Lymphocyte Activation Gene-3) protein which is a prognostic indicator for survival in breast cancers expressing oestrogen or progesterone receptors. This was shown is a study carried out by researchers at the René Huguenin Cancer Centre and Pr. Frédéric Triebel when he was at the Pharmacy Faculty of University Paris 11. These results paved the way for the current clinical trial.

International Copper Industry Defines Role In The Fight Against Hospital Infections

2009-01-06T13:24:00.000-08:00

The copper industry is working together to answer one very important question: Can copper and copper alloys (brass and bronze) help curb the spread of bacteria that cause hospital infection? Results of laboratory testing and clinical trials indicate that they can. Scientists from around the world shared their work at the first world congress, 'Copper and Public Health', on copper's role in fighting the bacteria that cause hospital-acquired infections. The conference was held in Athens, Greece in November.

Leading scientists from the U.K., U.S., Germany and Greece, representing the disciplines of infection control, pathology, microbiology, hospital design, metallurgy and engineering, presented the scientific evidence supporting the case for incorporating copper surfaces into healthcare environments to help reduce the risk of infection and to protect public health. The first results from a clinical trial in Birmingham, England, demonstrate that the use of copper on certain surfaces on a busy hospital ward resulted in 90-100 percent fewer micro-organisms than the amount found on the control ward.

In the U.S., hospital-acquired infections claim the lives of some 100,000 people each year. The U.S. Copper Development Association (CDA) is taking a lead role in this international effort through two main initiatives: EPA registration of copper and copper alloys as antimicrobial and the initiation of clinical trials in three U.S. hospitals.

The EPA registration was granted based on independent laboratory tests demonstrating that copper, brass and bronze are more than 99.9 percent effective in killing specific disease-causing bacteria, including Methicillin-resistant Staphylococcus aureus (MRSA), one of the most virulent strains of antibiotic-resistant bacteria and a common cause of hospital- and community-acquired infections.

The clinical trials are comparing the amount of bacteria found on stainless steel, plastic and aluminum objects in intensive care units with the amount found on the same objects made of antimicrobial copper alloys, such as brass and bronze, in order to determine if copper alloys can lessen cross contamination, and perhaps lower rates of infection. The trials are funded by the U.S. Department of Defense under the aegis of the Telemedicine and Advanced Technologies Research Center (TATRC), a section of the Army Medical Research and Materiel Command (USAMRMC).

Prolonged Nevirapine In Breast-Fed Babies Prevents HIV Infection But Leads To Drug-Resistant HIV

2009-01-06T13:21:00.000-08:00

Babies born to HIV-positive mothers and given the antiretroviral drug nevirapine through the first six weeks of life to prevent infection via breast-feeding are at high risk for developing drug-resistant HIV if they get infected anyway, a team of researchers report. But the investigators highlight the proven superiority of the six-week regimen in preventing mother-to-child HIV transmission in breast-fed infants

In a study led by researchers at Johns Hopkins Children's Center, risks of drug resistance in the first year of life were compared in Indian infants getting a standard single dose of nevirapine at birth and those on the six-week regimen.

"While extended nevirpaine prophylaxis dramatically reduces HIV transmission during the first six weeks of life, our data show that if infection does occur, it will most likely be with strains resistant to nevirapine, making HIV much harder to treat early with nevirapine," says senior investigator Deborah Persaud, M.D., a pediatric HIV expert at Hopkins Children's. "But until other interventions become available, the extended nevirapine regimen remains a reasonable way to prevent infections through breast-feeding."

Published in the Jan.1 issue of Public Library of Science One (PLoSOne), the research report emphasized that in the developing world especially, where bottle feeding is not safe, too expensive or simply unavailable, the extended nevirapine therapy remains one of the best ways to reduce mother-to-child transmission of HIV through breast milk.

Given the high risk of death from HIV in infancy, the benefits of fewer infections still outweigh the risk of increased resistance, the researchers conclude.

The findings also suggest that because of their higher risk for acquiring resistant HIV strains, infants given extended courses of nevirapine should they get infected should receive treatment with protease inhibitors (PIs), which are effective against nevirapine-resistant strains.

"In the developing world testing for resistance is not available or too expensive," Persaud says, "so if extended nevirapine regimens become widespread, PIs should be made available as a first line of treatment early on for all infants who get infected despite prophylaxis."

The new report comes on the heels of two separate multi-center studies from Johns Hopkins and other institutions, published in 2008, showing that a six-week regimen with nevirapine or a 14-week regimen with nevirapine slashed the risk of HIV infection from breast-feeding by 46 percent and 66 percent, respectively.

For the current study, investigators analyzed samples from 74 Indian babies infected with HIV before, during or after birth. Of the 74 infants, 22 were infected before birth, 19 were infected during birth or during early breastfeeding (three to six weeks after birth) and 33 were infected during late breast-feeding (around six months after birth). Of the 19 infants infected through breastfeeding in the first six weeks of life, four were given daily nevirapine for six weeks, and 15 received a single dose at birth. All four babies on extended nevirapine developed resistant strains of the virus, while only four of the 15 given a single dose tested positive for resistant strains after infection.

It is important to keep in mind that while the risk of resistance is higher with extended nevirapine regimens once infection occurs, the risk of acquiring HIV with extended regimens is dramatically reduced, the investigators say. Thus, in the long run, extended nevirapine regimens do not lead to more resistant cases than the single-dose regimens because single-dose regimens also carry some risk of resistance and are also less effective in preventing new infections.

Indeed, when researchers compared resistance among infants infected during late breast-feeding, the gap in resistance risk virtually disappeared. Fifteen percent of the 13 infants given extended nevirapine developed resistance, and so did 15 percent of the 20 infants who received a single dose of the drug.

When investigators used more sensitive assays to detect nevirapine-resistant mutations that are normally not detected by standard tests, the proportion of infants with resistant strains who had received single-dose nevirapine went up from 38 percent to 59 percent among the 29 infants who got the single dose, but remained unchanged in the group receiving the six-week regimen, 92 percent of 12. Likewise, the proportion of infants testing positive for resistance went up in the group infected after six weeks of age. In that group, 31 percent of 13 infants on the extended regimen tested positive for resistant strains, and 40 percent of 20 infants who got the single dose had resistant strains. However, researchers say, the clinical significance of mutations that are not detected by standard testing remains unclear.

The infants in this trial were infected with HIV subtype C, but previous studies have shown that the six-week regimen increases resistance in infants who get infected with other HIV subtypes as well.

Despite the risk of HIV transmission, breast-feeding for at least six months is widely encouraged by the World Health Organization (WHO) and other organizations as a proven factor in better infant survival. In 2007 alone, 420,000 infants acquired HIV in utero, during birth or during breast-feeding, according to WHO estimates. HIV infection is estimated to occur in 1 out of 10 breast-fed infants, with many of the infections occurring in the first six to 14 weeks of life.

The research was funded by the Elizabeth Glaser Pediatric AIDS Foundation and by the National Institutes of Health.

Anita Moorthy of Johns Hopkins is the first author on the study. Other Johns Hopkins investigators in the study: Robert Bollinger, Amita Gupta and Carrie Ziemniak. Investigators from the Indian arm of the trial include: Ramesh Bhosale, Renu Bharadwaj, Anju Kagal, Arvind Bhore and Varadharajan Venkataramani of Byramjee Jeejeebhoy Medical College; Skrikanth Tripathy, Smita Kulkarni and Madhuri Thakar of the National AIDS Research Institute; and Jayagowri Sastry, Sandesh Patil, Vandana Kulkarni, Usha Balasubramaniam, Nishi Suryavanshi, and Nikhil Gupte of the India SWEN Study Team.

Mesothelioma Medical Information

2008-11-23T10:39:00.000-08:00

Malignant mesothelioma is an aggressive but rare malignancy that principally affects the pleura and peritoneum. The pleura and peritoneum are lining that cover the lung (pleura) and the abdominal cavity (peritoneum). In recent years, a steady proportional increase in pleural tumors has been matched by a proportional decrease in peritoneal tumors. Roughly 80% of cases are believed to derive from occupational or paraoccupational exposure to primary asbestos fiber types (thus the high mesothelioma asbestos claim numbers); namely, crocidolite, amosite, and chrysotile in a ratio of 500:100:1, respectively, and, less commonly, by exposure to tremolite (which has little commercial value and is therefore mined in limited quantities). These are the cases most associated with mesothelioma lawsuits and claims across the country requiring the assistance of a mesothelioma lawyer. According to recent mesothelioma statistics from Great Britain's Health and Safety Executive's Epidemiology and Medical Statistics Unit, risk appears to be highest among workers associated with the following broad areas of asbestos use: shipbuilding, railway carriage and locomotive building, and installation/maintenance of insulation materials in buildings or industrial plants.

Epidemiologic Trends
Malignant mesothelioma develops after a long latency period that averages a mean of 32 years. Proportionally greater numbers of males vs females are affected (ratio approximately 3:1), and incidence follows a pattern that is defined by age and date of birth; this pattern parallels trends in asbestos exposure and associated changes in industrial consumption/use of asbestos fibers throughout the 20th century. Between 1973 and 1999, a total of 5266 mesothelioma cases were reported in the United States, at an average incidence rate of 0.97 per 100,000 people, and a higher overall incidence for men vs women (1.8/100,000 vs 0.4/100,000, respectively). Analogous to age-adjusted patterns, rates were nearly 50% higher in the 1980-1984 period compared with the 1975-1979 period, with the cohort effect peaking for males born between 1905 and 1909. Given exposure associations, the overall rate in females is unsurprisingly flat, and the estimated lifetime risk for women is 2.5 per 10,000 people. Because the use of asbestos has been banned in the United States since the 1970s, the number of male cases is expected to drop significantly during the next 50 years.
By contrast, during the same time period when asbestos was banned in the United States, asbestos imports were peaking in the United Kingdom. This accounts for the currently increasing incidence rate, from a current total of 1300 cases annually to a projected total of more than 3000 cases annually by the year 2021. In Western Europe -- specifically, Britain, France, Germany, Italy, The Netherlands, and Switzerland, which account for 75% of the entire Western European population -- asbestos use remained high until 1980, and substantial quantities are still used in several countries.

Summary and Conclusions
Although malignant mesothelioma has long been considered one of the more uncommon cancers in the Western hemisphere, a steady increase in case numbers, particularly in the United Kingdom, has created an urgency to find new treatments that offer fewer toxicities, better symptom control, increased antitumor activity, improved survival, and better overall QOL. Until recently, these goals remained elusive, and the strength of the evidence supporting any single treatment modality was weak.
Fortunately, the tide appears to be turning and the sense of nihilism surrounding mesothelioma treatment is dissipating. Greatly encouraging results from clinical trials suggest that combination chemotherapy utilizing at least one novel agent has an important, definitive role in disease management. At present, phase 3 data demonstrating significant improvements in survival, favorable tolerability, good antitumor activity, and increased QOL support the use of pemetrexed plus cisplatin as first-line therapy for malignant pleural mesothelioma. Other combinations, including gemcitabine plus cisplatin or carboplatin, and raltitrexed plus oxaliplatin, may, likewise, become standard therapy in the near future.
As mesothelioma information continues to mount that more firmly establishes the role of combination chemotherapy, researchers are beginning to make inroads into greater understanding of the biology of mesothelioma. Ultimately, new insights may provide novel therapeutic targets and a means to further improve outcomes.

Is It Ethical To Include Pregnant Women In Research?

2008-09-29T14:53:00.000-07:00

Why aren't pregnant women included in most clinical trials?

That's the question posed by leading bioethicists at Duke University Medical Center, Johns Hopkins and Georgetown Universities, who say it's time to confront the challenges that have led to the exclusion of pregnant women from important research that could positively impact maternal and fetal health.

"Only in the last two decades did people recognize that women were being excluded not just from the risks, but from the benefits of research -- primarily because of their potential to become pregnant or because of concerns that female physiology - such as menstrual cycles - might complicate study results," says Anne Drapkin Lyerly, MD, an obstetrician/gynecologist and medical ethicist at Duke.

She is the lead author of a paper appearing online and then in print in the November 2008 edition of the International Journal of Feminist Approaches to Bioethics detailing the justifications for responsibly including pregnant women in research. "While we've made significant progress in correcting the gender imbalance, we have a long way to go in protecting the health and safety of pregnant women and the fetuses they carry."

The Institute of Medicine has recommended that pregnant women be "presumed eligible" for participation in research since 1994. However, the authors say the "delicate condition" continues to be grounds for near-automatic exclusion from research, despite the need for more effective treatment for women during pregnancy

More than four million women give birth in the U.S. each year, and many face medical conditions during their pregnancies that require clinical treatment. In fact, Lyerly says chronic diseases occurring during pregnancy are common: chronic hypertension and diabetes complicate nearly four percent of pregnancies each year; and an estimated 500,000 pregnant women experience psychiatric illness, cancers, autoimmune diseases and other conditions that require treatment. But in the absence of research on how medications work in pregnant women, doctors are often left guessing about how to safely and effectively treat patients through pregnancy.

"Our best predictions when it comes to dosing medications can be disastrously wrong," says Lyerly. "This conservative stance doesn't help anybody. Without adequate research on how drugs are metabolized during pregnancy, how they are absorbed, distributed in and excreted by the body, whether they cross the placenta or affect the fetus, we have little to no evidence on how to optimize the health of pregnant women or the fetuses they carry."

Lyerly and her colleagues at Johns Hopkins University's Berman Institute of Bioethics and Georgetown University clearly recognize the many challenges that need to be addressed in order to safely include pregnant women in clinical research. In fact, they are convening a meeting with officials from the FDA, NIH and leading experts in obstetrics, gynecology and maternal/fetal medicine next year to address these issues and come up with practical, public policy and moral solutions.

"It's not simply a matter of including pregnant women in studies," Lyerly explains. "We need to address what we need to do to ensure maternal and fetal safety, which diseases we should study first, and what we should do when pharmaceutical companies or institutions say no."

Promising New TB Drug Receives Phase 2 SBIR

2008-09-29T14:51:00.000-07:00

Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat infectious diseases of epidemic potential, has announced that it received a $2.3 million, three-year Small Business Innovative Research (SBIR) grant from the National Institutes of Health (NIH),

National Institute of Allergy and Infectious Diseases (NIAID) for the development of SQ641, a promising new tuberculosis (TB) drug with potential to provide early and prolonged bacterial clearance during the intensive phase of TB treatment.

The Phase 2 SBIR grant will fund the conduct of several IND-related critical path studies, including delivery optimization in vivo.

Dr. Carol Nacy, CEO of Sequella said, "The NIH is a model example of how strong public/private partnerships help advance new infectious disease therapies into the drug pipeline and we thank them for this grant support. SQ641 is a potentially powerful antitubercular compound with a unique target of action. The SBIR grant award is scientific validation of our research and development efforts to identify important new drugs for diseases of concern to the global health community."

Results of the completed Phase 1 SBIR grant demonstrated that SQ641 has superior in vitro activity against Mycobacterium tuberculosis compared to all other TB drugs. It has a unique mechanism of action and a unique target, the translocase 1 (TL-1) enzyme, which is not the target of any existing antitubercular. In addition, SQ641 possesses exceptional activity against all members of the Mycobacteria family of bacteria, including M. tuberculosis, M. avium complex, and other pathogenic nontubercular Mycobacteria.

About SQ641

SQ641 is the lead drug candidate from a 7000-compound library of semi-synthetic TL-1 inhibitors developed as potential treatments for TB or bacterial pneumonia (Streptococcus pneumoniae). The compound inhibits TL-1, an enzyme required for cell wall synthesis in all bacteria, including Mycobacteria. Sequella licensed the compound library from Daiichi-Sankyo (November 2004). Daiichi-Sankyo identified the compound class and performed extensive research and preliminary preclinical development on several drug leads. Sequella has exclusive rights to the series of TL-1 inhibitors for the treatment of TB and all other indications for nearly every worldwide market.