Thursday, May 27, 2010

FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli

The U.S. Food and Drug Administration today advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

The FDA has approved a revised label for the prescription drug Xenical. The agency is working with the manufacturer of Alli on label revisions to reflect this rare occurrence.

Both Xenical and Alli are medications contain the same active ingredient, orlistat. Xenical, available only by prescription, contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli.

The FDA’s safety information and labeling changes are based on a review of cases of severe liver injury reported in individuals taking orlistat. The agency has identified 13 cases of severe liver injury, 12 of which were reports from outside of the United States. The only U.S. report of severe liver injury involved Alli. At this time, a cause-and-effect relationship of severe liver injury with orlistat use has not been established.

People who take Xenical or Alli should be aware that liver injury with orlistat – while rare – has been reported. Those taking the drug also should be aware of the signs and symptoms of liver injury, which include itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.

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ARCA Launches First Therapeutic Trial with GeoVax Vaccine

PRNewswire-- GeoVax Labs, Inc. (OTC Bulletin Board: GOVX), a biotechnology company that creates, develops and tests innovative HIV/AIDS vaccines, announced today The AIDS Research Consortium of Atlanta (ARCA) has received approval to begin enrollment of the first therapeutic trial ever conducted using a promising HIV vaccine candidate from GeoVax, Inc. Although the GeoVax vaccines are currently being studied for HIV prevention, this is the first study using the same products for treatment of persons who already have HIV infection. ARCA is the only site for this trial.

"ARCA is pleased to be conducting this important clinical trial," said Dr. Melanie Thompson, Principal Investigator for ARCA. "New approaches to HIV treatment are critically needed, and an effective therapeutic vaccine would be an important tool in our ongoing efforts to treat people with HIV infection. A vaccine that enhanced the body's ability to control HIV and delayed or decreased the dependence on anti-HIV drugs would be a major breakthrough for HIV treatment."

To be eligible for the study, persons should have had a negative HIV test followed by a positive test up to 6 months later, and they should have started drugs to fight HIV within 6 months of being diagnosed. The study will last up to 77 weeks. All patients will be followed closely for safety and for the ability of the vaccine to elicit protective immune responses in vaccinated participants. Patients will be compensated for their participation in the study. Only 10 to 12 persons will be selected to participate. Persons who believe they may qualify for the study should contact ARCA at or 404-876-2317. ARCA is also interested in identifying possible candidates who fit the enrollment criteria but have not yet started anti-HIV drugs.

ARCA worked together with GeoVax to design the protocol for the Phase 1 clinical trial. The trial is based on the achievement of excellent post-vaccine viral control in animal studies conducted in recently infected non-human primates at the Yerkes National Primate Research Center, affiliated with Emory University.

About the AIDS Research Consortium of Atlanta

ARCA is a registered 501(c)(3) not-for-profit clinical research, testing, outreach and educational organization founded in 1988. ARCA works through a network of more than 50 physicians and 5 public health clinics to conduct clinical drug and vaccine trials and prevention research studies. 2 ARCA also provides patient and care-provider educational programs, free STD testing for men, and free, anonymous HIV testing when funds are available. More than 6000 Atlantans have learned their HIV status through ARCA's HIV testing program. ARCA has become one of the most respected and successful HIV/AIDS research facilities in the country over the past two decades by enrolling more than 2,000 metro Atlanta residents in more than 300 clinical drug trials that provide the latest investigational HIV/AIDS medications at no cost to them. ARCA has contributed key scientific information leading to the FDA approval of more than 27 individual and combination drugs now available for people with HIV/AIDS worldwide. ARCA was one of only three centers in the US that participated in a Centers for Disease Control and Prevention (CDC) study to test the safety of tenofovir, an existing HIV medicine, as a possible tool to prevent HIV infections. Over a 14 year period, ARCA enrolled more than 10.000 Atlantans with HIV infection in a CDC study to better understand HIV and AIDS. In all, more than 20,000 Atlantans have participated in ARCA studies and services. For more information, visit

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Tuesday, May 25, 2010

FDA Clears First 2009 H1N1 Influenza Virus Test Previously Available Under Emergency Use Authorization

The U.S. Food and Drug Administration  announced it has cleared the Simplexa Influenza A H1N1 (2009), a test for the 2009 H1N1 Influenza Virus in patients with signs and symptoms of respiratory infection.

Until this clearance, tests for 2009 H1N1 Influenza were only available through an Emergency Use Authorization (EUA), which allows the FDA, based on the evaluation of available data, to authorize the use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products, during the time a declaration of emergency is in effect.

On April 26, 2009, the U.S. Department of Health and Human Services declared a public health emergency due to the 2009 H1N1 Influenza Virus. EUAs for devices will cease to be effective when the public health emergency declaration expires.

“With this clearance, the availability of Simplexa H1N1 test will not be affected when the public health emergency expires,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

Using specimens from nasal swabs or nasal aspirates, the Simplexa Influenza A H1N1 (2009) test simultaneously amplifies and detects two regions of the influenza virus genome and an internal control. A positive result indicates that the patient is infected with the 2009 H1N1 influenza virus, but the test does not indicate the stage of infection. A negative result does not preclude influenza virus infection.

The United States experienced its first wave of 2009 H1N1 Influenza Virus in the spring of 2009, followed by a second wave in the fall. The U.S. Centers for Disease Control and Prevention estimates that between 43 million and 88 million cases of 2009 H1N1 occurred between April 2009 and March 13, 2010.

The Simplexa Influenza A H1N1 (2009) test is manufactured by Focus Diagnostics Inc. in Cypress, Calif.

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FDA Approves New Treatment for Late-Onset Pompe Disease

The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder.

Pompe disease occurs in an estimated 1 in every 40,000 to 300,000 births. Its primary symptom is heart and skeletal muscle weakness, progressing to respiratory weakness and death from respiratory failure.

In Pompe disease, a gene mutation prevents the body from making an enzyme, or making enough of the enzyme called acid alpha-glucosidase (GAA), necessary for proper muscle functioning. GAA is used by the heart and muscle cells to convert a form of sugar called glycogen into energy. Without the enzyme action, glycogen builds up in the cells and, ultimately, weakens the heart and muscles.

Lumizyme is believed to work by replacing the deficient GAA, thereby reducing the accumulated glycogen in heart and skeletal muscle cells.

“Pompe disease is a devastating condition without the appropriate treatment,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research. “The approval of Lumizyme will provide an important treatment for patients diagnosed later in life with Pompe disease.”

Lumizyme is being approved with a risk evaluation and mitigation strategy (REMS). It will only be available through a restricted distribution system called the Lumizyme ACE (Alglucosidase Alfa Control and Education) Program to ensure that it is used by the correct patient group.

Lumizyme will carry a Boxed Warning because of the risk of anaphylaxis, severe allergic reactions, and immune-mediated reactions.

Currently, the only other treatment for Pompe disease available in the United States is Myozyme, which is also manufactured by Genzyme at its manufacturing facilities in Framingham and Allston Landing, Mass. Myozyme has been in short supply due to limited manufacturing capacity. The manufacturer reserved Myozyme to treat infants and children with Pompe disease because younger patients generally have a much more aggressive form of the disease.

Some adult patients in the U.S. received Lumizyme under a temporary access program. The approval of Lumizyme will ensure that treatment is available for all U.S. adult Pompe patients in need of treatment. Lumizyme is manufactured at Genzyme facilities in Ireland and Belgium.

Lumizyme’s safety and effectiveness have not been evaluated in patients with infantile-onset Pompe disease or in patients ages 8 years and younger with late-onset disease. These patients should be treated with Myozyme, not Lumizyme.

The safety and efficacy of Lumizyme are based on a clinical study in 90 patients, ages 10 years to 70 years, with late-onset Pompe disease. The most commonly reported side effects for Lumizyme were infusion-related reactions and included severe allergic reactions, hives, diarrhea, vomiting, shortness of breath, itchy skin, skin rash, neck pain, partial hearing loss, flushing, pain in extremities, and chest discomfort.

Myozyme and Lumizyme are marketed by Cambridge, Mass.-based Genzyme.

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Friday, May 14, 2010

FDA Revises Recommendations for Rotavirus Vaccines

The U.S. Food and Drug Administration today revised its recommendations for rotavirus vaccines for the prevention of the disease in infants and has determined that it is appropriate for clinicians and health care professionals to resume the use of Rotarix and to continue the use of RotaTeq.

The agency reached its decision based on a careful evaluation of information from laboratory results from the manufacturers and the FDA’s own laboratories, a thorough review of the scientific literature, and input from scientific and public health experts, including members of the FDA’s Vaccines and Related Biological Products Advisory Committee that convened on May 7, 2010 to discuss these vaccines.

The FDA also considered the following in its decision:

* Both vaccines have strong safety records, including clinical trials involving tens of thousands of patients as well as clinical experience with millions of vaccine recipients.
* The FDA has no evidence that PCV1 or PCV2 pose a safety risk in humans, and neither is known to cause infection or illness in humans.
* The benefits of the vaccines are substantial, and include prevention of death in some parts of the world and hospitalization for severe rotavirus disease in the United States. These benefits outweigh the risk, which is theoretical.

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Thursday, May 13, 2010

Report: Up to 1 in 10 Americans May Suffer From Food Allergies

/PRNewswire/ -- A review published Wednesday in the Journal of the American Medical Association (JAMA) and reported in the New York Times underscores the need for additional research on the prevalence, diagnosis, and treatment of food allergy. One of the most important points suggested by the JAMA study as well as a New York Times article on the subject is that as many as 1 in 10 people may have food allergy.

A May 11 New York Times article regarding JAMA's review states that "true incidence of food allergies is only about 8 percent for children and less than 5 percent for adults."

Between 2 and less than 10 percent of the population has food allergy, according to the JAMA review, "Diagnosing and Managing Common Food Allergies." This figure clearly illustrates the need to increase government commitment to research, testing, and education of a growing problem.

"The systematic review of the food allergy literature published in JAMA is helpful in crystallizing the fact that food allergy is common, affecting millions of Americans, but also points out that we need much more research to better understand the exact prevalence, and how to prevent, more easily diagnose, and treat this life-changing medical problem," said Scott H. Sicherer, M.D., professor of pediatrics, clinician, and clinical researcher at Jaffe Food Allergy Institute, Mount Sinai School of Medicine in New York.

The Centers for Disease Control and Prevention has reported an 18 percent increase in food allergy among children from 1997-2007 and a 3.5-fold increase in hospital admissions related to food allergy among children between the period from 1998-2000 to 2004-2006. The CDC also estimates about 4 percent of U.S. children under the age of 18 have a food allergy.

However, despite these statistics, just $26 million was appropriated last year for research on food allergy, a potentially life-threatening medical condition. The National Institutes of Health last year allocated $175 million for autism funding, which is estimated to affect 1 in 100 children.

JAMA's review was conducted in conjunction with the National Institute of Allergy and Infectious Diseases, which is drafting national Guidelines to the Diagnosis and Management of Food Allergies. The Food Allergy & Anaphylaxis Network (FAAN) and The Food Allergy Initiative (FAI), which have long focused on the need for clinical studies dedicated to food allergy, applaud the government for undertaking these guidelines.

The New York Times article also states that many people who think they have a food allergy actually do not. There is no dispute that many individuals are misdiagnosed with food allergies. Better diagnostic tools are needed. The gold standard for food allergy diagnosis, a double-blinded, placebo-controlled food challenge, is not typically used by allergists because they are not being fully reimbursed for this time-consuming, expensive and potentially dangerous procedure. Funding of this procedure should be addressed by insurance companies.

While improved data on prevalence is necessary, the potential severity of a food allergy reaction is such that individuals should err on the side of caution and assume they have a food allergy and practice avoidance until they are properly diagnosed.

Researchers throughout the world are working diligently to find treatments and a cure for food allergy. FAAN and FAI call upon the federal government to help find a cure for food allergy by providing the necessary funding for quality research.


Founded in 1991 by Anne Munoz-Furlong, the Food Allergy & Anaphylaxis Network (FAAN) is the world leader in information about food allergy, a potentially life-threatening medical condition that afflicts approximately 12 million Americans, or one out of every 25. A nonprofit organization based in Fairfax, Va., FAAN has approximately 25,000 members in the U.S., Canada, and 58 other countries. It is dedicated to increasing public awareness of food allergy and its consequences, to educating people about the condition, and to advancing research on behalf of all those affected by it. FAAN provides information and educational resources about food allergy to patients, their families, schools, health professionals, pharmaceutical companies, the food industry, and government officials. For more information, please visit FAAN at


The Food Allergy Initiative (FAI) is a national 501(c)(3) nonprofit organization that funds research seeking a cure for food allergies. FAI was founded in 1998 by concerned parents and grandparents to support basic and clinical research worldwide; public policies to make the world safer for those afflicted; and educational programs to make the hospitality industry, schools, day care centers, and camps safer. The largest private source of funding for food allergy research in the United States, FAI has contributed more than $65 million toward the fulfillment of its mission. For more information, visit, call 212-207-1974, or e-mail

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Thursday, May 6, 2010

UGA discovery holds promise for treatment of diabetes and other debilitating diseases

Two University of Georgia animal science researchers introduced to the world 13 pigs that may hold the key to new therapies to treat human diseases, including diabetes. Announced this week, the discovery marks the first time pluripotent stem cells, or cells that can turn into any type of cell in the body, have been created from adult livestock.

We now for the first time have a method to make pigs that can be a source of cells and organs for regenerative medicine in a meaningful way said Steven L. Stice, a Georgia Research Alliance Eminent Scholar in Reproductive Physiology. A faculty member in the UGA College of Agricultural and Environmental Sciences, Stice also directs UGA's Regenerative Bioscience Center. The technique called induced pluripotent stem cells had only previously been shown to make live offspring in mice.

"These first-in-the-world, pig-induced pluripotent cells-generated animals can eventually be used to provide and search for better therapies and cures for human disease and regenerative conditions," Stice said.

The discovery is a new tool for researchers who need to determine which sources of cells, adult or earlier stages such as embryonic or induced pluripotent stem cells, will work best for each disease.

The induced pluripotent stem cells piglets were born Sept. 3, 2009. The process used avoids the more problematic and controversial cloning process while making it easier to make the genetic changes necessary to develop pigs as a better source of cells and organs for transplantation.

"Although induced pluripotent stem cell technology was first successful in mice, they aren't always a good model to study human disease and they are not a good source of tissue and organs for therapy,"  Stice said. "Pigs are often the best way to go."

Stice credits Franklin West, an assistant research scientist, with perfecting the method.

"I've worked on this for about 20 years," Stice said. "Franklin found the way to make it work."

The pluripotent stem cells incorporated naturally into the developing fetuses and contributed to the development of many cell types of the body, such as lungs, kidney, heart, skin or muscle, producing healthy piglets, West said. And 80 percent of the animals produced using this new method are a product of these stem cells, a very high percentage.

The new process will be valuable for a research project under way in partnership with Emory University to find better therapies for diabetes.

"Islets that produce insulin and other hormones related to regulating blood sugar are found in the pancreas," Stice said. "It is well known that porcine islet cells could be a major break through in the treatment of Type I (juvenile) diabetes if they were not rejected by the human immune system. This new method will allow researchers to make the necessary genetic changes to dampen or potentially eliminate the rejection of the new stem cells and then we can make animals from these stem cells."

Another goal, Stice said, is for the study results to lead the way to healthier, more environmentally friendly and disease-resistant livestock, and ones that could help reduce poverty or starvation in developing countries.

Once the new pigs reach sexual maturity and Stice and West determine if the pigs produce viable sperm and egg cells, they can begin naturally mating. The offspring of the current pigs will produce the cells needed to move into the therapy stage and clinical trials.

Details of the discovery will be published in the journal Stem Cells and Development next month.

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Wednesday, May 5, 2010

Stool DNA Testing Could Play Expanded Role in Colon Cancer Prevention

(BUSINESS WIRE)--Research teams led by Mayo Clinic have demonstrated for the first time that two types of colorectal pre-cancers can be detected through noninvasive stool DNA testing. The two studies being presented demonstrate that stool DNA testing may be useful for detection of premalignant dysplasia in patients with inflammatory bowel disease (IBD) and of an important type of colorectal pre-cancer called serrated polyps. The findings were presented at Digestive Disease Week 2010, the annual meeting of the American Gastroenterological Association.

“This was significantly higher than the 7 percent rate with conventional fecal blood tests.”

David Ahlquist, M.D., a gastroenterologist with Mayo Clinic and the senior investigator, said that sensitive stool DNA test methods developed at Mayo Clinic can detect common forerunners of colorectal cancer. “Detection of precursor lesions during screening is essential if cancer prevention is the goal,” Dr. Ahlquist says.

Compared to widely used fecal blood tests, stool DNA testing has higher detection rates for curable stage colorectal cancer and for common precancerous polyps (called adenomas).

Detection of Colorectal Precancerous Lesions in Inflammatory Bowel Disease

The first study, presented on May 3 at Digestive Disease Week, involves identifying both cancer and a precancerous lesion, called dysplasia, in people who suffer from IBD. In a blinded study with 10 cases and 10 controls done in conjunction with Mount Sinai Medical Center and the University of Chicago, researchers found that stool DNA testing was positive in nine out of 10 cases (five of five with cancer, and four of five with dysplasia).

“This study shows that cancer and pre-cancer in IBD can be detected noninvasively,” says Dr. Ahlquist. “The 90 percent detection rate by stool DNA testing is remarkable. It’s important for people with IBD because they are at much higher risk for colorectal cancer than the general population. Given the limitations of colonoscopies in detecting these lesions, stool DNA testing could play a complementary role to improve the effectiveness of cancer surveillance.”

Detection of Serrated Colorectal Polyps

The second study, presented on May 4, involves detecting serrated colorectal polyps. Unlike common adenomas, which usually protrude from the colon lining and are easy to see, serrated polyps are typically flat and the same color as the colon lining. Dr. Ahlquist says serrated polyps have been ignored or excluded from most screening studies to date because it wasn’t clear they were associated with cancer. “Now they are regarded as the forerunner in roughly 30 percent of colon cancers,” says Dr. Ahlquist. “Most of these are located on the right side of the colon, where screening has had less impact historically.”

For this study, researchers first took tissue and identified two genetic markers that were present in serrated polyps but not in normal colon. The team assayed the markers (mutant BRAF and methylated vimentin genes) in stool samples from 14 cases and 19 control patients who had undergone screening colonoscopies. In blinded fashion, they compared results to fecal blood tests on the same specimens.

“We observed a 71 percent detection rate with stool DNA testing,” says Dr. Ahlquist. “This was significantly higher than the 7 percent rate with conventional fecal blood tests.”

“Detection of these important types of precancer by stool DNA testing offers promise in our efforts to more effectively and affordably prevent colorectal cancer,” says Dr. Ahlquist. “However, findings from both pilot studies need to be corroborated in larger studies.”


The studies were funded by the National Institutes of Health and the Charles Oswald Foundation. Mayo Clinic co-authors for the colorectal neoplasia and inflammatory bowel disease study include John Kisiel, M.D.; Tracy Yab; Fareeda Hussain, William Taylor; Jonathan Harrington; Mary Devens; Julie Simonson; Megan Garrity-Park; William Sandborn, M.D.; Edward Loftus, M.D; and Hongzhi Zou, M.D., PhD. Co-authors for the serrated colorectal polyps study include Hussain, Yab, Harrington, Taylor, Thomas Smyrk, M.D.; Douglas Mahoney; and Dr. Zou.


Drs. D. Ahlquist and D. Zou, Mses. T. Yab and F. Hussain; and Messrs. Taylor and Harrington and Mayo Clinic have a financial interest related to technology used with this research. This technology has been licensed to Exact Sciences. Mayo Clinic stands to receive royalties from the licensing of this technology and holds an equity position in Exact Sciences.

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Monday, May 3, 2010

Older Women with Diabetes Face Higher Risk for Colon Cancer

(BUSINESS WIRE)--A research team led by Mayo Clinic physicians has found that older women with diabetes face a more than doubled risk for some types of colorectal cancer. The findings are being presented at Digestive Disease Week 2010, the annual meeting of the American Gastroenterological Association.

Colorectal cancer ( remains the third-leading cause of cancer deaths among women in the United States. Diabetes has been identified as a colon cancer risk factor, but the mechanisms aren’t completely understood. For this population-based cohort study, researchers examined data from 37,695 participants of the Iowa Women’s Health Study (IWHS), which enrolled women ages 55–69 in 1986 and remains ongoing. Of these women, 2,361 reported a diagnosis of Type 2 diabetes and 1,200 developed colorectal cancer.

To find the links between colorectal cancer and diabetes, the researchers worked with regional pathology laboratories to obtain tumor tissue samples from IWHS participants who were diagnosed with colorectal cancer. They linked the tissue samples with other IWHS data, looking for cancer pathways and risk factors, and whether those risk factors were associated with three different molecular markers: microsatellite instability (MSI), CpG island methylation (CIMP), and BRAF gene mutations.

“Diabetes was more strongly associated with the MSI-high, CIMP-positive and BRAF-mutation cancer subtypes in this group of older women,” says Mayo Clinic gastroenterologist Paul Limburg, M.D. ( Dr. Limburg explains that diabetes appeared to confer a greater than twofold increase in risk for these molecularly-defined tumors, compared to women without diabetes.

“Knowing that diabetic women have these findings should help to facilitate more appropriate colorectal cancer prevention and treatment options,” says Anthony Razzak, M.D., a Mayo Clinic research fellow and presenter at the conference. “Our findings may lead to new strategies for colon cancer screening, chemotherapy and chemoprevention in women with diabetes.”

“From a research perspective, this information allows us to clarify how environmental exposures and other risk factors might effect tumor formation at a molecular level,” says Dr. Razzak. For future projects, the researchers will work to understand more about the biology of colorectal cancer and how it is influenced by diabetes, as well as other chronic conditions and exposures. They hope to use that information to improve patient care.

“Unfortunately, diabetes and colon cancer are both very common in the United States, so making links between these disorders has substantial public health implications,” says Dr. Limburg.

Mayo Clinic’s Division of Gastroenterology and Hepatology ( has been ranked No. 1 in the U.S. News & World Report Honor Roll of Top Hospitals since the rankings began 20 years ago.


The study was funded by the National Cancer Institute. Additional Mayo Clinic co-authors are Amy Oxtenko, M.D.; Robert Vierkant; Lori Tillmans; Alice Wang; Susan Slager, Ph.D; Thomas Smyrk, M.D.; Stephen Thibodeau, Ph.D.; and James Cerhan, M.D., Ph.D. Co-authors from other institutions are Daniel Weisenberger, Ph.D., and Peter Laird, Ph.D., both of the University of Southern California Epigenome Center; Charles Lynch, M.D., Ph.D., University of Iowa College of Public Health, Iowa City; Kristin Anderson, Ph.D., and Lisa Harnack, Ph.D., both of the University of Minnesota Cancer Center, Minneapolis; Robert Haile, Ph.D., of the University of Southern California School of Medicine, Los Angeles; and John Potter, M.D., Fred Hutchinson Cancer Research Center, Seattle.

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