Thursday, July 29, 2010

HIV Components Drive Bone Breakdown, Even without Active Infection

Although individuals who are HIV positive can now expect to live longer because of the availability of anti-retroviral drugs, this advance brings on new health challenges. It is estimated that the majority of the HIV-infected population of the United States will be older than 50 by 2015.

The intersection of aging and HIV infection appears to have a destructive impact on bone health. Researchers at Emory University School of Medicine have shown in an animal model that the presence of HIV proteins, even without a replicating virus, leads to alterations in cells that break down bone.

The team's results were published this week online in the Early Edition of the Proceedings of the National Academy of Sciences.

"We found that HIV proteins, by themselves, can alter the output of hormones that affect the balance between bone formation and bone breakdown leading to bone loss," says senior author M. Neale Weitzmann, MD, assistant professor of endocrinology at Emory University School of Medicine. "This information could help doctors decide the best way to stave off osteoporosis and bone fractures, which are becoming increasingly common in individuals living with HIV infection."

Collaborating authors are David Guidot, MD, director of the Division of Pulmonary, Allergy and Critical Care Medicine at Emory and director of the Emory Alcohol and Lung Biology Center; and Igho Ofotokun, MD, assistant professor of medicine (infectious diseases).

The Emory team studied rats that have an HIV virus that cannot replicate incorporated into their DNA. The virus does not kill white blood cells directly as it does in human patients, but parts of the virus appear in the rats' blood, and appear to distort the function of immune cells.

Compared to normal rats, the HIV-transgenic rats' bone mineral density (determined by X-rays) in the femur was reduced by 36 percent, while the proportion of bone in the trabecular (spongy) areas of their femurs was reduced by 32 percent.

Some of the reduction in bone mass may be because the HIV-transgenic rats weigh 21 percent less, but they also have more osteoclasts-- cells that originate in the bone marrow that break down bone. The authors found that in the HIV-transgenic rats, B cells (a variety of immune cells) produce more of certain hormones that promote osteoclast differentiation. For instance, their B cells produce more RANKL, a key osteoclast promoting factor and the target of an anti-osteoporosis drug called denosumab, and less osteoprotegerin, an osteoclast inhibitor, Weitzmann says.

Previous studies have shown that viral infection drives changes in the balance of the types of B cells present in HIV-infected people. Weitzmann says the next step in the team's research will be to examine B cell subpopulations in HIV-infected people, and to measure their output of hormones involved in bone growth and breakdown.

The research was supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Allergy and Infectious Diseases and the Department of Veterans Affairs.

T. Vikulina et al. Alterations in the immuno-skeletal interface drive bone destruction in HIV-1 transgenic rats. PNAS Early Edition (2010).

Community News You Can Use
Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Wednesday, July 28, 2010

FDA Approves Drug for Chronic Drooling in Children

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow. Cuvposa reduces drooling by lowering the volume of saliva produced.

Glycopyrrolate was approved decades ago to treat peptic ulcers and reduce salivation in patients under anesthesia. Until now, glycopyrrolate has been used on an off-label basis to treat drooling in the developmentally disabled population, but in a different dosage form than the approved product. A drug is said to be used off-label when a physician prescribes its use in a different way than described in the FDA-approved drug label.

In 2001, the FDA held an advisory committee meeting to discuss how best to develop products for drooling with ethically and scientifically sound trials in children who have neurological disorders. Utilizing the advice provided, the FDA has been able to move forward in addressing the needs of this population.

"Cuvposa provides an important therapy for controlling salivation in patients with neurologic disease," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "FDA approval not only ensures that the product meets modern standards for safety, effectiveness, quality and labeling; but, also results in a more suitable dose form for this patient population."

The FDA drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product. For instance, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. FDA's review of the applicant's labeling ensures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.

When used off label, oral tablets of glycopyrrolate had to be crushed to treat drooling in children with neurological disorders. Cuvposa is a flavored oral solution that is easier to administer and provides the optimal dose for each patient.

In clinical trials of Cuvposa glycopyrrolate oral solution, 78 percent of the children on the drug reached clinical improvement in drooling compared with 19 percent of those given an inactive substance (placebo).

Common adverse reactions reported with glycopyrrolate are dry mouth, constipation, flushing, and urinary retention.

Cuvposa (glycopyrrolate) Oral Solution is marketed by Shionogi Pharma Inc. of Osaka, Japan.

Community News You Can Use
Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Tuesday, July 27, 2010

Dengue Fever and Insect-Borne Infections Emerging as Public Health Problem in Areas of the United States

/PRNewswire/ -- Several cases of dengue fever, a potentially fatal viral disease transmitted by the bite of urban dwelling Aedes aegypti and Aedes albopictus mosquitoes, have recently been reported in the continental United States. Prevalent in Central America and the Caribbean, dengue fever's most common symptoms include fever, chills, headache, and body aches lasting several days. The disease's more threatening form, dengue hemorrhagic fever, can cause internal bleeding, loss of blood pressure, and death. Over the past five years, outbreaks of both forms of the disease have been reported in Texas and Florida.

Despite the threat of further introduction of dengue into the mainland United States, as well as the risk of introduction of additional vector-borne diseases, President Obama's 2011 fiscal budget reduces to zero the funding to support the vector-borne infectious disease program at the Centers for Disease Control and Prevention (CDC), the only national program that focuses of detection and outbreak control of vector-borne diseases including dengue, plague, viral encephalitis and Lyme disease.

"At the American Society for Tropical Medicine and Hygiene, we are concerned that the currently proposed 2011 budget would not provide sufficient funding for this important government function. One in fifty people in the world dies of an illness acquired from an insect bite, and tens of thousands of Americans already fall ill each year from infections transmitted by mosquitoes and ticks. Insects do not respect state borders, and neither can our national response," said Edward T. Ryan, M.D., President, American Society of Tropical Medicine and Hygiene (ASTMH). "Although we recognize and applaud the need to constantly scan the Federal budget to identify outdated or unnecessary programs, eliminating the CDC's vector-borne infectious disease program is not one of these areas. The proposed cuts to this program would be shortsighted, and would harm the health of the American people."

Considering dengue as an example, beginning in the 1980s, dengue fever re-emerged as a widespread tropical infection throughout Central America and the Caribbean, pervasive in Cuba, the Dominican Republic, and Puerto Rico. Tens of thousands of cases of dengue and several thousand dengue hemorrhagic fever cases occur annually across Central America and the Caribbean. The disease's reach is not limited to these regions, however. In 2005, dengue fever emerged in Brownsville, TX and in 2009, the disease returned to the Florida Keys, after a 75-year hiatus. These recent outbreaks of dengue and dengue hemorrhagic fever suggest that the disease could spread and become a health threat in major Gulf Coast cities such as Corpus Christi, Houston, New Orleans, Biloxi, Mobile, Pensacola and Tampa, as well as in less populated areas.

The World Health Organization estimates that 2.5 billion people (two fifths the world's population), risk contracting dengue, and that there may be as many as 50 million cases of dengue fever every year. The disease disproportionately affects poor populations, whose low-quality living conditions and link to poor sanitation are conducive to the establishment of mosquito breeding sites, and increase this demographics' contact with Aedes mosquitoes. Currently, there is no vaccine approved to protect humans against dengue, and the most effective protective measures are those to avoid mosquito bites (wearing bug repellent, spraying pesticides, and dumping any standing water). If infected, the early recognition and prompt treatment can help lower the risk of developing severe disease complications.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

FDA Grants Orphan Drug Status for Personalized Cancer Vaccine, BiovaxID®, Targeting Mantle Cell Lymphoma

(BUSINESS WIRE)--Biovest International, Inc. (OTCQB: “BVTI”) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BiovaxID®, Biovest’s personalized cancer vaccine, for a second lymphoma indication: mantle cell lymphoma. Mantle cell lymphoma is an aggressive and lethal B-cell blood cancer for which there is no current consensus standard-of-care. Mantle cell lymphoma is the newest disease for which Biovest has announced its intent to pursue regulatory approval for and Orphan Drug Designation represents a significant development step in the Company’s regulatory strategy. The FDA previously granted Orphan Drug Designation for BiovaxID for the treatment of indolent follicular non-Hodgkin’s lymphoma. BiovaxID represents a new class of active immunotherapy and is one of the few select late-stage, patient-specific cancer vaccines vying to be among the first to reach market.

With FDA Orphan Drug Status granted for this second indication, Biovest gains seven-years of market exclusivity for BiovaxID upon approval for the treatment of mantle cell lymphoma and/or indolent follicular lymphoma, thereby offering competitive protection from similar drugs of the same class. Orphan Drug Status also provides Biovest with eligibility to receive potential tax credit benefits, potential grant funding for research and development and significantly reduces the requisite filing fees for marketing applications.

According to Biovest’s Vice President, Product Development & Regulatory Affairs, Dr. Carlos F. Santos, “Orphan Drug Designation is an important step in our regulatory strategy. With promising clinical trials now complete in both follicular lymphoma and mantle cell lymphoma, we are preparing to seek regulatory approvals for BiovaxID in two separate indications. In addition to our ongoing regulatory efforts with regard to follicular lymphoma, we look forward to formally presenting our mantle cell Phase II clinical trial results to the FDA, and potentially the EMEA, later this year, as we explore potential expedited market registration pathways to offer this therapeutic vaccine regimen as a new treatment option for mantle cell patients.”

In the BiovaxID mantle cell lymphoma Phase II study, tumor-specific immune responses were observed in 87% of the patients vaccinated with BiovaxID following rituximab-containing chemotherapy (EPOCH-R). Consistent with all other BiovaxID studies, the vaccine was very well tolerated and safe.

Biovest’s President, Samuel S. Duffey added, “As we prepare to exit reorganization as a fully restructured public company, we remain firmly committed to our goal to bring needed new therapies to patients suffering with lymphoma. I am pleased that we received Orphan Designation for mantle cell lymphoma, and I am excited about our opportunity to potentially advance the role of personalized cancer vaccines for the treatment of lymphoma.”

About Biovest International, Inc.

Biovest International, Inc. is an emerging leader in the field of active personalized immunotherapies targeting life-threatening cancers of the blood system. Developed in collaboration with the National Cancer Institute, BiovaxID® is a patient-specific, cancer vaccine, demonstrating statistically significant Phase III clinical benefit by prolonging disease-free survival in vaccinated patients suffering from indolent follicular non-Hodgkin’s lymphoma, confirming a previous positive Phase II study. BiovaxID has been granted “Fast-Track” status and Orphan Drug Designation for the treatment of follicular lymphoma by the FDA and Orphan Drug Designation by the European EMEA. A BiovaxID Phase II clinical trial treating patients suffering with mantle cell lymphoma, an incurable and aggressive type of non-Hodgkin’s lymphoma, also demonstrated promising results with the FDA granting Orphan Drug Designation for this second targeted indication.

Biovest is also developing and marketing a proprietary line of automated hollow fiber bioreactor systems, including the innovative AutovaxID™ which is a production platform for the scalable manufacture of difficult-to-produce biologics including personalized medicines, monoclonal antibodies, cell culture vaccines and therapeutics targeting highly infectious agents. Since 1981, Biovest has been offering its clients a wide range of instrumentation and cell culture contract manufacturing services. Headquartered in Tampa, Florida with its bio-manufacturing facility based in Minneapolis, Minnesota, Biovest is publicly-traded on the OTCQB™ Market with the stock-ticker symbol “BVTI”, and is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (Other OTC: “ABPIQ”).

For further information, please visit:

Forward-Looking Statements:

Statements in this release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to statements about BiovaxID®, AutovaxID™, events occurring after dates hereof, and any other statements relating to products, product candidates, product development programs, the FDA or clinical study process including the commencement, process, or completion of clinical trials or the regulatory process. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, expectations and intentions, and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results of Biovest to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for product candidates; competition from other pharmaceutical or biotechnology companies; and the additional risks discussed in filings with the Securities and Exchange Commission. All forward-looking statements are qualified in their entirety by this cautionary statement, and Biovest undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. The product names used in this statement are for identification purposes only. All trademarks and registered trademarks are the property of their respective owners.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

New Survey by Enzymedica Links Autism & Digestion, Suggests Successful Strategies

(BUSINESS WIRE)--Autism is the fastest growing developmental disorder in the world. With 1 child in 91 facing the disorder, the diagnosis is more common than pediatric cancer, diabetes, and AIDS combined.

“A product containing a full spectrum blend of all enzymes is considered an ideal digestive aid.”

Autism and Digestion: The Surprising Link

A new survey by Enzymedica and the Enzyme Research Group (ERG), links autism and digestive problems, and suggests diet modification and dietary supplements as successful tools for families facing the diagnosis.

While autism is generally considered a neurological disorder, the new survey reminds us that autistic children face additional health challenges, including 80% who report digestive difficulty, sensitivity, or intestinal inflammation.

Survey Participants Tout Special Diets for Autism

Food sensitivities and cravings are widespread in the autism community. The ERG survey found that 35% of children craved sugary treats, 30% dairy, 25% wheat and 32% junk foods; and cravings were not mutually exclusive.

Interestingly, the craved foods also caused the greatest digestive reaction. Lactose, gluten, casein, and phenol were the top reactive contenders in children on the spectrum.

* 70% currently follow, or have tried, a restrictive diet
* 52% gluten-free
* 55% casein-free
* 44% eliminate artificial flavors and additives
* 70% use digestive enzymes or probiotics

Since even healthy foods can cause problems, supplementation can be used to prevent nutritional deficiency. 80% of parents said they offer dietary supplements in some form, typically in combination with a special diet, to soothe and support healthy digestion, and reduce dietary sensitivities.

Healthy Digestion Requires Digestive Enzymes

Our body uses enzymes to enhance digestion and turn the food we eat into energy. Produced throughout the digestive tract, and available from raw foods and supplements, these enzymes include amylase for carbohydrates, lipase for fats, protease for proteins, and cellulase for fiber.

“Many of our children are enzyme deficient,” writes Elizabeth Lipski, Ph.D., C.C.N., a board-certified clinical nutritionist in her book, Digestive Wellness for Children. “These deficiencies can play a pivotal role in the development of childhood disease.” Lipski has over 20 years experience working in the field of holistic and complementary medicine and views enzymes as the body’s workhorses.

“In children, enzyme supplements have been used successfully to treat food allergies, gastroenteritis, asthma, and other illnesses, and research on enzymes for children is promising,” she continues.

Like healthy bones and muscle tissue, our enzyme producing organs rely on good nutrition to fuel production. Physical stressors and inflammation are also implicated as a component in compromised enzyme capacity, and these conditions are common with autism.

The ERG researchers found a statistically significant 80% of autistic children experience digestive disturbances related to certain types of food, with dairy topping the list. 57% said dairy is the culprit, and wheat was second in line with 43%.

Autism Breeds Picky Eaters

“Many children on the spectrum are unwilling to eat a sufficient quantity of raw, unprocessed foods,” declares Kristin Selby Gonzalez, Director of Autism Education for Enzymedica, herself the mother of a son with autism. “It’s unfortunate because these healthy foods naturally contain the enzymes and micronutrients needed to support a healthy intestine and aid digestion.”

Taking a daily enzyme supplement can create the foundation of a healthy digestive process,” says Ellen Cutler, D.C., whose Mill Valley, California practice caters to patients with allergies and digestive distress. “A product containing a full spectrum blend of all enzymes is considered an ideal digestive aid.”*

While typical parents may experience difficulty getting growing children to eat their fruits and veggies, consider the behavioral challenges present in some autism diagnoses. Families with autistic children often find mealtime a battleground.

The junk foods and processed snacks craved by many children on the spectrum contain common allergens which cause food sensitivities. These types of foods are hard to digest and are a frequent and familiar source of the constipation and diarrhea autistic children experience.

Science Investigates the Autism / Digestion Link

A 2009 study in Pediatics, described a gene called MET, involved in both brain development and the process of gastrointestinal system repair. The study indicated a genetic variation may contribute to increased risk for autism spectrum disorder that includes familial gastrointestinal dysfunction.

More than 58% of parents, aunts and uncles, 45% of grandparents, and 20% of siblings reported problems in the ERG survey. While still considered controversial, the new survey indicates the familial autism/digestion link may indeed be viable.

Diet and Enzymes Provide Hope

“Given the option, my son would survive on processed snacks and treats like cookies, crackers, chicken nuggets and French fries,” declares Gonzalez. “I’ve learned by keeping them out of his diet and adding enzymes Jaxson behaves better, his attention is more focused, and many of his digestive reactions evaporate.”*

To read the results of the entire survey, please visit To learn more about Enzymedica’s commitment to the autism community, visit

About the Survey:

Enzymedica sponsored the recent survey in association with The Enzyme Research Group. The survey evaluated 143 parents with children on the autism spectrum, surveying their experience with digestive health issues. The survey was conducted online and in anonymous interview and ran from May – June, 2010.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Friday, July 23, 2010

Length of Stay in ERs Reaches New High, Delays in Moving Admitted Patients Out of ERs Blamed

/PRNewswire/ -- Average length of stay in the nation's emergency departments increased to four hours and seven minutes, and the nation's emergency physicians are very concerned about patient safety being jeopardized by long wait times. Press Ganey's Pulse Report 2010, released yesterday, confirms what the American College of Emergency Physicians has reported previously: The recession, high unemployment and insurance losses are increasing pressure on emergency departments and their patients.

Dr. Angela Gardner, president of the American College of Emergency Physicians, assessed the report's findings:

"The report finds pockets of good news, such as shorter times overall in Nevada, but nobody can possibly call a national average of more than four hours in the emergency department something to cheer about. Last year the GAO reported that even patients who need to be seen in 1 to 14 minutes are waiting an average of 37 minutes for care. Emergency physicians have become masters of improvisation and troubleshooting under extreme conditions, but the fundamental problems in our emergency departments remain unsolved.

"Hospitals need to stop boarding admitted patients in the emergency department and get them to the appropriate inpatient floor quickly. That is what's best for the admitted patients but it's also what's best for the patients suffering in the waiting room. The full capacity protocol ( has been proven effective in numerous emergency departments, but many hospitals continue to resist implementing it. That's bad for patients.

"Policymakers and the public should also have no illusions that the recently passed health care legislation is going to decrease ER use. Massachusetts, which enacted health care reform in 2006, has seen an increase in emergency department visits, with no decrease in patient acuity. It proves that health care coverage is no guarantee of health care access.

"Hospital emergency departments continue to close, which reduces access to emergency care still further. More patients plus fewer ERs equals longer wait times. Nearly one-quarter of hospitals report periods of ambulance diversion because they are over capacity. A longer ride to the hospital is not good medicine.

"This report is yet another wake-up call that health care reform has yet to address the acute care needs of 123 million emergency patients a year. They may report being satisfied with the care they are receiving in the ER, but emergency physicians are dissatisfied with an average time in the emergency department that is nearly equal to a coast to coast airplane ride."

ACEP is a national medical specialty society representing emergency medicine. ACEP is committed to advancing emergency care through continuing education, research and public education. Headquartered in Dallas, Texas, ACEP has 53 chapters representing each state, as well as Puerto Rico and the District of Columbia. A Government Services Chapter represents emergency physicians employed by military branches and other government agencies.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Thursday, July 22, 2010

Federal Government Seizes Cyanide Antidote Kits from California Company

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California.
The seizure warrant was issued by the U.S. District Court for the Central District of California.

Marketed for use in cases of cyanide poisoning, Keystone distributes the kits primarily to hospitals in the United States and Canada. The products contain a Sodium Thiosulfate injection and a Sodium Nitrite injection in vials, along with components such as needles, tubing, and a syringe.

Most commonly, cyanide exposure occurs through inhaling smoke in residential fires, or through inhaling cyanide fumes during industrial accidents.

The cyanide antidote kits distributed by Keystone are unapproved new drugs under the Federal Food, Drug and Cosmetic Act and are therefore not permitted to be introduced into interstate commerce. The products have not been proven safe and effective for their intended use.

The kits also are misbranded because their labeling does not contain adequate directions for their use. Additionally, the seized products are adulterated because they were manufactured under conditions not in compliance with current Good Manufacturing Practice (cGMP) to assure that they meet the identity, quality, and purity standards they claim to possess.

“The FDA is taking this action because Keystone has refused to take these unapproved products off the market,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “This action is a significant step in protecting the public health.”

In October 2008, the FDA issued a warning letter to Keystone’s contract manufacturer, PrimaPharm of San Diego. That letter identified numerous cGMP violations and informed PrimaPharm that the Keystone Sodium Thiosulfate Injection and the Keystone Sodium Nitrite Injection were unapproved new drugs. The FDA also twice warned Keystone verbally that it should not distribute the unapproved drugs in the cyanide antidote kits.

After an FDA inspection of PrimaPharm between August and September 2009 found continuing cGMP violations, the contract manufacturer said it would no longer accept orders from Keystone to manufacture the injections or kits.

An FDA inspection of Keystone between September and October 2009 revealed that the firm had continued to distribute the unapproved drugs in the cyanide antidote kits still in inventory and did not intend to stop. Keystone was given numerous opportunities to come into compliance, but the company failed to cease distributing the unapproved new drugs.

The FDA advises hospitals or organizations that purchased these products to return the unapproved products to Keystone.

To date, the agency has not received reports of adverse reactions linked to the Keystone cyanide antidote products.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Vaccine-Delivery Patch with Dissolving Microneedles Boosts Protection

A new vaccine-delivery patch based on hundreds of microscopic needles that dissolve into the skin could allow persons without medical training to painlessly administer vaccines -- while providing improved immunization against diseases such as influenza.

Patches containing micron-scale needles that carry vaccine with them as they dissolve into the skin could simplify immunization programs by eliminating the use of hypodermic needles -- and their "sharps" disposal and re-use concerns. Applied easily to the skin, the microneedle patches could allow self-administration of vaccine during pandemics and simplify large-scale immunization programs in developing nations.

Details of the dissolving microneedle patches and immunization benefits observed in experimental mice were reported July 18th in the advance online publication of the journal Nature Medicine. Conducted by researchers from Emory University and the Georgia Institute of Technology, the study is believed to be the first to evaluate the immunization benefits of dissolving microneedles. The research was supported by the National Institutes of Health (NIH).

"In this study, we have shown that a dissolving microneedle patch can vaccinate against influenza at least as well, and probably better than, a traditional hypodermic needle," said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering.

Just 650 microns in length and assembled into an array of 100 needles for the mouse study, the dissolving microneedles penetrate the outer layers of skin. Beyond their other advantages, the dissolving microneedles appear to provide improved immunity to influenza when compared to vaccination with hypodermic needles.

"The skin is a particularly attractive site for immunization because it contains an abundance of the types of cells that are important in generating immune responses to vaccines," said Richard Compans, professor of microbiology and immunology at Emory University School of Medicine.

In the study, one group of mice received the influenza vaccine using traditional hypodermic needles injecting into muscle; another group received the vaccine through dissolving microneedles applied to the skin, while a control group had microneedle patches containing no vaccine applied to their skin. When infected with influenza virus 30 days later, both groups that had received the vaccine remained healthy while mice in the control group contracted the disease and died.

Three months after vaccination, the researchers also exposed a different group of immunized mice to flu virus and found that animals vaccinated with microneedles appeared to have a better "recall" response to the virus and thus were able to clear the virus from their lungs more effectively than those that received vaccine with hypodermic needles.

"Another advantage of these microneedles is that the vaccine is present as a dry formulation, which will enhance its stability during distribution and storage," said Ioanna Skountzou, an Emory University assistant professor.

Pressed into the skin, the microneedles quickly dissolve in bodily fluids, leaving only the water-soluble backing. The backing can be discarded because it no longer contains any sharps.

"We envision people getting the patch in the mail or at a pharmacy and then self administering it at home," said Sean Sullivan, the study’s lead author from Georgia Tech. "Because the microneedles on the patch dissolve away into the skin, there would be no dangerous sharp needles left over."

The microneedle arrays were made from a polymer material, poly-vinyl pyrrolidone, that has been shown to be safe for use in the body. Freeze-dried vaccine was mixed with the vinyl-pyrrolidone monomer before being placed into microneedle molds and polymerized at room temperature using ultraviolet light.

In many parts of the world, poor medical infrastructure leads to the re-use of hypodermic needles, contributing to the spread of diseases such as HIV and hepatitis B. Dissolving microneedle patches would eliminate re-use while allowing vaccination to be done by personnel with minimal training.

Though the study examined only the administration of flu vaccine with the dissolving microneedles, the technique should be useful for other immunizations. If mass-produced, the microneedle patches are expected to cost about the same as conventional needle-and-syringe techniques, and may lower the overall cost of immunization programs by reducing personnel costs and waste disposal requirements, Prausnitz said.

Before dissolving microneedles can be made widely available, however, clinical studies will have to be done to assure safety and effectiveness. Other vaccine formulation techniques may also be studied, and researchers will want to better understand why vaccine delivery with dissolving microneedles has been shown to provide better protection.

Beyond those already mentioned, the study involved Jeong-Woo Lee, Vladimir Zarnitsyn, Seong-O Choi and Niren Murthy from Georgia Tech, and Dimitrios Koutsonanos and Maria del Pilar Martin from Emory University.

"The dissolving microneedle patch could open up many new doors for immunization programs by eliminating the need for trained personnel to carry out the vaccination," Prausnitz said. "This approach could make a significant impact because it could enable self-administration as well as simplify vaccination programs in schools and assisted living facilities."

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Wednesday, July 21, 2010

CKW & Associates Manages Concept to Opening

Cobb County Specialty Pediatric Medical Practice Opens New Facility

Children’s Orthopaedics of Atlanta opened a new location in Marietta, Ga. Expanding to meet the needs of a growing pediatric community, this is their fifth location in Georgia. Construction management by CKW & Associates, LLC ensured the project was completed almost three weeks prior to move in and significantly under budget. Project Architect was Peacock Architect and General Contractor was Peacock Builders.

The new office totals almost 6,000 square feet of medical space including 15 exam rooms and x-ray facilities. Children Orthopaedics of Atlanta in Marietta is located at 175 White Street, Suite 200, Marietta, Ga.

"We have a long standing relationship with Children’s Orthopaedics of Atlanta. As their partner for build-outs and development projects, we are able to help them expand quickly to meet the needs of patients and families they serve," said Todd Cohen, principal with CKW & Associates.


About CKW & Associates
Located in Atlanta, Georgia, CKW & Associates specializes in the management of high quality design and construction from concept through completion, enabling clients to focus on their core business, saving them time and money. The company provides comprehensive management for all related design and construction activities to ensure the highest level of quality. For more information please call CKW & Associates at 404-537-5800 or visit our website at

About Children’s Orthopaedics of Atlanta 

With five locations throughout metro Atlanta, Children's Orthopaedics of Atlanta is recognized nationally as one of the most highly respected pediatric orthopaedic centers treating many thousand patients each year. Children ranging in age from infancy through adolescence seek specialized medical and surgical care for a variety of musculoskeletal diseases and injuries. For more information visit

Tuesday, July 20, 2010

Abzyme Research Foundation Announces Promising HIV Vaccine Candidate

/PRNewswire/ -- The Abzyme Research Foundation announces today that Dr. Sudhir Paul, a scientist at University of Texas Houston Medical School, has identified an important immunological deficiency in HIV-infected patients and has created a promising HIV vaccine candidate that rectifies the deficiency. The discoveries were presented on July 19th and 20th, 2010 at the XVII International AIDS Society Conference in Vienna, Austria.

The HIV vaccine candidate has been tested in mice and rabbits. It was effective in inducing the production of protective antibodies that stopped the HIV from infecting human blood cells in laboratory tests.

Dr. Paul and his colleagues discovered that HIV patients do not produce sufficient protective antibodies of a type called IgG that are capable of attacking the vulnerable CD4 binding site on the HIV. The virus binds to human host cells through this site to cause infection. The CD4 binding site is a small part of gp120, a protein found on the surface of HIV. Studies of mice injected with gp120 confirmed an insufficient IgG response to the CD4 binding site. Previous vaccine tests by other researchers used the gp120 protein itself without success in protecting against infection.

"Using an electron-seeking form of gp120, we triggered the production of the crucial IgG antibodies to the CD4 binding site in animals," said Dr. Paul. "We believe this method is the key to developing an HIV vaccine."

Dr. Paul's team has found that chemical stimulation of the immune system by electron-seeking (electrophilic) proteins is the central step for rectifying the defective antibody response to the CD4 binding site. Since the structure of the CD4 binding site is very similar in all HIV strains throughout the world, a globally effective HIV vaccine may be possible.

Lead E-VAC Candidate

The researchers have developed a synthetic electrophilic vaccine candidate, or E-VAC, which works by focusing the antibody response at the CD4 binding site. The E-VAC is a synthetic portion of gp120 that successfully mimics the shape of the CD4 binding site expressed by the HIV virus. Administration of E-VAC to animals induces antibodies with enzymatic activity, or abzymes. Unlike traditional antibodies that neutralize the target on a 1:1 basis, abzymes are significantly more efficacious because each abzyme molecule can neutralize thousands of target molecules.

E-VAC administered to mice and rabbits induced the production of blood-borne IgG antibodies that blocked the infection of human cells by genetically divergent HIV-1 strains from across the world.

"We are backing the research of Dr. Paul's team because his approach using abzymes shows enormous progress in creating an HIV vaccine," said Alan Kleiman, chairman of the board for the Abzyme Research Foundation. "Our foundation aims to drive discovery and innovation in the field of HIV research in hopes of one day eliminating the HIV/AIDS pandemic."

The lead E-VAC was developed from recent proof-of-concept studies that validated targeting of the CD4 binding site and chemical stimulation of the immune system as published recently by Dr. Paul's team in the journals AIDS and The Journal of Biological Chemistry. The work is being conducted at the University of Texas Houston Medical School and California Department of Public Health with support from the National Institutes of Health.

In addition to Dr. Paul, key contributors are Drs. Stephanie Planque, Yasuhiro Nishiyama and Carl Hanson. Dr. Planque is presenting the results at the Vienna AIDS Conference. Dr. Planque's paper was selected by International AIDS Society for the IAS/ANRS Young Scientist Award to be presented at the Conference.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Thursday, July 15, 2010

First Smallpox Vaccine for Special Populations Delivered Under Project BioShield

Delivery to the Strategic National Stockpile of the first 1 million doses of the nation's first smallpox vaccine for certain immune-compromised populations is now complete, the result of a Project
BioShield contract.

Under this contract the Danish company Bavarian Nordic is manufacturing and delivering 20 million doses of its next generation smallpox vaccine known as modified vaccinia Ankara (MVA) or Imvamune. Delivery of the first million doses began in May and deliveries will continue through
2013. The contract is administered by the Biomedical Advanced Research and Development Authority, BARDA, a part of the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.

In an emergency, such as the virus being obtained from a secure lab and used in an act of terrorism, the vaccine may be authorized for use to protect people who have weakened immune systems, specifically HIV persons who have not progressed to AIDS. Addressing the needs of such special populations is mandated under the Pandemic and All-Hazards Preparedness Act (PAHPA).

The Strategic National Stockpile (SNS), operated by the Centers for Disease Control and Prevention (CDC), has large quantities of medicine and medical supplies to protect the American public if there is a public health emergency, such as a terrorist attack or flu outbreak, severe enough to cause local supplies to run out. Once federal and local authorities agreed that the SNS supplies were needed medicines could be delivered to any state in the U.S. within 12 hours. Each state has plans to receive and distribute SNS medicine and medical supplies to local communities as quickly as possible.

Project BioShield gives BARDA the contracting authority to develop and procure medical countermeasures against chemical, biological, nuclear and radiological threat agents. In 2007, Bavarian Nordic was awarded a $505 million contract to develop and deliver the MVA smallpox vaccine to the SNS. This contract was the first to use advance and milestone payments under Project BioShield as modified by PAHPA.

"This product began with a basic research and development program initiated by the National Institute of Allergy and Infectious Disease at the National Institutes of Health in 2003, and progressed to the point that Project BioShield could be used for further development and procurement," said BARDA Director Dr. Robin Robinson. "It represents a concerted, coordinated effort among federal agencies and with the private sector throughout the R&D process. It's a model for us going forward."

As a next step, BARDA is supporting Bavarian Nordic's work to improve the product further by developing a freeze-dried version of Imvamune. The freeze-dried formulation may have an improved shelf-life, reduced storage costs, and simplified transportation logistics compared to the
current vaccine formulation.

U.S. government agencies including BARDA, CDC, the National Institutes of Health, the Food and Drug Administration, and the Department of Defense have collaborated to develop requirements and policies, provide guidance, and work with manufacturers to develop and procure smallpox
medications and vaccines - known as medical countermeasures - for the SNS.

BARDA, within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides a comprehensive integrated portfolio approach to the advanced research and development, stockpile acquisition, innovation, and manufacturing
infrastructure building of the necessary vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health medical emergencies including chemical, biological, radiological, and nuclear threats, and pandemic influenza, and emerging infectious diseases. For additional information, visit

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Wednesday, July 14, 2010

Four New Research Studies Describe Experimental Immunotherapies for Alzheimer's

/PRNewswire/ -- The primary therapeutic target in Alzheimer's disease has been the beta amyloid peptide, which clusters outside cells in the brain to form sticky clumps known as plaques. Recently, more attention has been given to the tau protein, which aggregates inside the brain cells of people with Alzheimer's, forming neurofibrillary tangles. Precisely how these proteins interact in causing the disease is unclear.

Four new research studies reported today at the Alzheimer's Association International Conference on Alzheimer's Disease 2010 (AAICAD 2010) in Honolulu, HI describe experimental immunotherapies for Alzheimer's two of which target tau directly and two of which may reduce tau even though their primary target was beta amyloid.

"It is very important that we have a variety of therapeutic targets in the fight against Alzheimer's disease," said William Thies, PhD, Chief Medical and Scientific Officer at the Alzheimer's Association. "The more opportunities that we investigate to intervene and change the relentless and progressive course of Alzheimer's, the better chance that we will find something that works."

"Importantly, these studies teach us more not only about tau-targeted therapies but also about the progression of Alzheimer's disease," Thies added. "It may be that amyloid changes in the brain happen early in the disease and tau-related changes happen 'downstream' where they have a more direct effect on cognitive function. However, this is still to be determined."

"We need more basic research about what causes Alzheimer's, as well as therapy-related studies, to fill the front end of the drug pipeline and get us the better treatments and prevention strategies that we so desperately need to head off the epidemic of Alzheimer's," Thies said.

Beta Amyloid Immunotherapy with Bapineuzumab in Alzheimer's May Also Reduce Tau

Bapineuzumab (Janssen Alzheimer Immunotherapy and Pfizer) is an antibody to the beta amyloid plaques that are associated with Alzheimer's disease, and is currently in Phase 3 testing as a treatment for mild to moderate Alzheimer's. An abnormal form of the tau protein known as phospho-tau (P-tau) forms into tangles which are the other established lesions in the brain of people with Alzheimer's. The amount of P-tau in cerebrospinal fluid (CSF) is believed to be a marker of active loss of brain cells in people with Alzheimer's; prior studies have shown increases in P-tau in people with mild cognitive impairment who later develop Alzheimer's. P-tau was studied as a therapeutic biomarker in the Phase 2 clinical trials of bapineuzumab.

The pooled exploratory analysis reported at AAICAD 2010 by Kaj Blennow, MD, PhD, of the University of Gothenburg, Sweden, and colleagues included a subgroup of participants from two randomized, multicenter, double-blind, placebo-controlled, multiple-ascending-dose studies conducted in the United States (Study 201) or in the United Kingdom and Finland (Study 202). Study 201 enrolled 35 patients (20 bapineuzumab, 15 placebo) in the CSF substudy, and Study 202 enrolled 11 patients (7 bapineuzumab, 4 placebo) in the CSF substudy. CSF was collected at baseline and 2 weeks after the week 52 infusion.

The researchers found that Study 201 showed a trend (p=0.0564) towards a decrease in CSF P-tau in bapineuzumab-treated compared with placebo-treated cases. In Study 202, no significant treatment effects were seen. When they combined data from both studies, they found a statistically significant decrease (p=0.0270) in P-tau in bapineuzumab-treated compared with placebo-treated patients.

"These observations suggest that immunotherapy treatment targeting amyloid may also alter neurodegenerative processes that occur later in the disease process and that are more directly associated with loss of function," Blennow said. "However, this was a small study and these findings need to be confirmed."

Another Immunization Therapy for Alzheimer's with Beta Amyloid Also Reduces Tau

AN1792 (Elan) showed early promise as a beta amyloid immunotherapy for Alzheimer's. In 2002, a Phase 2 trial reported that about 6 percent of participants developed serious brain inflammation symptoms resembling meningoencephalitis. The trial was stopped as was further clinical development. However, participants in the first AN1792 trial continue to be observed.

Delphine Boche, PhD, of the University of Southampton's School of Medicine, UK, and colleagues studied the levels of beta amyloid and phospho-tau in six regions of cerebral grey matter that are affected by Alzheimer's pathology in the brains of 10 people with Alzheimer's who were immunized with AN1792 and compared the findings with 28 unimmunized Alzheimer cases. They had previously shown a reduction of beta amyloid in people treated with AN1792 and now looked to see if it had any effect on tau.

The researchers found statistically significant reductions in tau and beta amyloid in the immunized patients compared with untreated Alzheimer's. The reduction in tau appeared to be specifically in the dendrites, which are the branched projections of a neuron that conduct the electrochemical stimulation received from other nerve cells to the cell body. In contrast, tau in the bodies of the nerve cells, where the tangles form, seemed unaffected.

"The findings show that treatment aimed at beta amyloid may also modify tau changes in Alzheimer's," Boche said. "The lack of change in tau in the bodies of nerve cells might explain why the people in the original AN1792 trial didn't experience an improvement in cognitive functioning even though we saw amyloid clearance."

"This study demonstrates a link between these two Alzheimer's-related proteins, which has been suspected but not clearly demonstrated in the human brain. The findings give us more basic information about the interaction between beta amyloid and tau in Alzheimer's and may clarify how the disease progresses in the brain," Boche said.

Tau Antibodies Reduce Brain Tangles in Alzheimer-Model Mice

Allal Boutajangout, PhD, of the New York University School of Medicine, and colleagues previously reported that active tau immunization clears tau tangles from the brain and reduces or prevents functional impairments in two different tangle-model mice. In a study reported at AAICAD 2010, they assessed the efficacy of passive immunization for 13 weeks with the PHF1 antibody to tau in a mouse model of Alzheimer's tangles.

The researchers found that weekly injections of PHF1 in the tangle mice reduced the amount of tau aggregates in the brain and decreased functional impairment. The treated mice performed better than controls on the traverse beam task (p<0.03), and had 58 percent less tau pathology in the hippocampus (p=0.02). Plasma levels of PHF1 were inversely related to levels of tau pathology in two brain sections - the brain stem (p<0.01) and motor cortex (p=0.06) - indicating that higher dose of antibodies may have a greater therapeutic effect.

"Targeting hyperphosphorylated tau by immunotherapy is emerging as a promising approach to treat tau-related diseases such as Alzheimer's disease and frontotemporal dementia," Boutajangout said. "Further studies are needed to determine the feasibility of this approach with other tau antibodies and in different tangle models that more closely resemble Alzheimer's."

Alzheimer's Tau Vaccine Shows Promise in a New Rat Model of the Disease

Scientists led by Prof. Michal Novak, MDV, PhD, DSc, of the Institute of Neuroimmunology, Slovak Academy of Sciences, Bratislava, Slovakia and Co-Founder and Chief Scientific Officer of the Axon Neuroscience GmbH, Vienna, Austria, have developed a new transgenic rat model of Alzheimer's that, according to Novak, for the first time expresses non-mutated tau and generates Alzheimer's neurofibrillary tangles. Axon is using the rat for early, preclinical development of an Alzheimer's tau vaccine.

In a study reported at AAICAD 2010, Axon transgenic rats were immunized with phospho-tau. The scientists measured changes in functions related to behavior and learning, levels of phosphorylated tau in cerebrospinal fluid, and level of tangle pathology in the rat brains. They found that tau immunization significantly reduced the amount of insoluble tau, prevented development of neurofibrillary tangles, and produced a statistically significant delay of progressive impairment in learning behaviors.

"The Axon Alzheimer Rat may offer new avenues in developing the next generation of therapies and diagnostics for Alzheimer's," Novak said.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Friday, July 9, 2010

Statement from Secretary Sebelius on Reallocating $25 million for AIDS Drug Assistance

The U.S. Department of Health and Human Services took an important step to improve access to critical HIV/AIDS prescription drugs. The $25 million reallocated for AIDS drug assistance provides resources to States that have AIDS Drug Assistance Program (ADAP) waiting lists or have implemented strategies to contain costs and delay or prevent a waiting list.

This week, we improved access to critical HIV/AIDS prescription drugs and are continuing to work towards preventing, and ultimately eliminating, the need for ADAP waiting lists. Governors will soon receive a letter detailing how to access these funds. The Administration has been steadily increasing funding and while this is a significant infusion of funds, on top of more than $800 million already specifically allocated to the ADAP Program this year, the Federal government cannot do this alone--States and Pharmaceutical companies also need to do their part.

Improving access to care and treatment for people living with HIV is a top priority for HHS. These funds are just one part of a broader effort we are making to improve the health status of people living with HIV. Created under the Affordable Care Act, the Pre-Existing Condition Insurance Plan will provide a new health coverage option for Americans who have been uninsured for at least six months and have been unable to get health coverage because of a health condition-including HIV. This option will be available until 2014, when insurers will be banned from discriminating against adults with pre-existing conditions.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Growing Scientific Evidence Supports New Solution for Menopausal Symptoms

/PRNewswire/ -- The findings of a scientific conference examining the growing body of research and potential health benefits of S-equol were published this month in the Journal of Nutrition. Manuscripts based on presentations made at the conference, which was organized by the Life Sciences Research Office (LSRO), reveal data that S-equol is a safe, natural and effective solution to providing relief of menopausal symptoms such as hot flashes and muscle discomfort.

S-equol is a compound that is produced by intestinal bacteria through metabolizing or converting daidzien, an isoflavone found in soy. S-equol is thought to bind to the estrogen beta receptors which studies suggest is not associated with breast cancer risk. Further study is underway to confirm this hypothesis. Interestingly, only 20 to 30 percent of women are equol producers--a determination based on the type of bacteria present in the intestines and the amount of soy consumed.

To establish the current state of the science regarding S-equol and to explore future research needs, LSRO brought together the leading experts in soy and menopause research for a summit in Washington, DC. Several studies exploring the possible therapeutic role of S-equol in treating menopausal symptoms were presented. These studies indicated that a daily dose of 10 mg of S-equol decreased menopausal symptoms. In a confirmation study, menopausal women who were not equol producers who consumed 10 mg daily of S-equol for 12 weeks had significantly reduced hot flashes as well as a significant reduction in the severity of their muscle discomfort. The equol-ingesting group also showed trends of improvement in sweating and irritability.(1)

The change in estrogen levels during menopause can also affect bone health. Clinical evidence demonstrates that S-equol can help preserve bone. In one study, women who could produce S-equol had a significantly lower percent change in bone loss at the total hip (a decrease of 0.46 percent) than that of the nonproducers (a decrease of 2.28 percent). (2) Furthermore, a two-year randomized placebo-controlled trial that characterized postmenopausal women by their S-equol-producing status, showed that those who were S-equol producers had a 2.4 percent increase in the lumbar spine bone mineral density (BMD) compared with just 0.6 percent increase in the S-equol non-producers. (3) These results suggest that using soy isoflavones to prevent bone loss in women in early post-menopause may depend on an individual's S-equol-producing capacity.

Experts at the summit also discussed future research needs to better understand the role of S-equol in relieving menopausal symptoms. They concluded that opportunities now exist to determine whether the effects of equol on menopausal symptoms, such as hot flashes, sleep disturbances, bone health, in S-equol producers can be extended to S-equol non-producers via supplements. For more information on the research on Natural S-equol, please visit

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Thursday, July 8, 2010

FDA Warns of Risks with Unapproved Use of Malaria Drug Qualaquin

The U.S. Food and Drug Administration today warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps has resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks.

Qualaquin is not FDA-approved to treat or prevent night time leg cramps.

A review of reports submitted to the FDA’s Adverse Event Reporting System (AERS) between April 2005 and Oct. 1, 2008, found 38 U.S. cases of serious side effects associated with the use of quinine, the active drug in Qualaquin.

Quinine use resulted in serious and life-threatening reactions in 24 cases, including low level of platelets in the blood (thrombocytopenia), and hemolytic uremic syndrome/thrombotic thrombocytopenic purpura, a blood disorder that results in clots in small blood vessels around the body that can be accompanied by kidney impairment.

In some patients, these side effects resulted in permanent kidney impairment and hospitalization. Two patients died. Most of those reporting serious side effects took the drug to prevent or treat leg cramps or restless leg syndrome.

The risk management plan, called a Risk Evaluation and Mitigation Strategy (REMS), requires that patients be given a Medication Guide explaining what Qualaquin is and is not approved for, as well as the potential side effects of the drug. The company is also required to issue a Dear Health Care Provider Letter warning of the potential risk of serious and life-threatening blood-related (hematologic) reactions.

“Health care professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of night time leg cramps,” said Edward Cox, M.D., M.P.H., director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “FDA has received reports that some patients have developed serious side effects when taking quinine for night time leg cramps.”

Qualaquin was approved by the FDA in August 2005 to treat uncomplicated malaria caused by the parasite Plasmodium falciparum, an infection that can be life-threatening if untreated. According to the U.S. Centers for Disease Control and Prevention, about 1,500 cases of malaria are diagnosed in the United States each year, primarily resulting from travel abroad.

Qualaquin is marketed by Philadelphia-based AR Scientific.

Health care professionals and patients may report serious adverse events (side effects) to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone.

* Online
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500. Mail to address on the pre-addressed form.
* Fax: 800-FDA-0178
* Phone: 800-332-1088

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Wednesday, July 7, 2010

FDA Approves First Implantable Miniature Telescope to Improve Sight of AMD patients

The U.S. Food and Drug Administration  announced July 6 it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD).

Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times.

AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television.

"This innovation has the potential to provide many people with an improved quality of life," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.

The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.

The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract.

Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program.

In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment.

Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively.

To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT.

As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

Sunday, July 4, 2010

FDA Approves First Generic Effexor Extended Release Capsules to Treat Major Depressive Disorder

On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.

Venlafaxine hydrochloride extended-release capsules in 37.5 milligram, 75 milligram and 150 milligram strengths have been approved to be manufactured by TEVA Pharmaceuticals, North Wales, Pa.

“The approval of this widely used antidepressant is another example of the FDA’s efforts to increase access to safe and effective generic drugs,” said Keith Webber, Ph.D., deputy director of the Office of Pharmaceutical Science in the FDA’s Center for Drug Evaluation and Research. “Access to treatments for depression is important because depression can interfere with a person’s daily life and routine, which can significantly affect relationships with family and friends.”

Symptoms of depression can include feelings of sadness, anxiety, emptiness, hopelessness, guilt, worthlessness or helplessness. Irritability and restlessness are also common symptoms of depression. Many people with depression lose interest in activities or hobbies and feel tired all the time.

The prescribing information (label) for the generic drug may differ from that of Effexor XR capsules because some uses of the drug and parts of the label are protected by patents and/or exclusivity held by the Effexor manufacturer, Wyeth Pharmaceuticals Inc.

Generic venlafaxine hydrochloride will have the same safety warnings as Effexor XR.

The drug has a boxed warning indicating that antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. The warning also notes that depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage

FDA Approves Rapid Test for Antibodies to Hepatitis C Virus

The U.S. Food and Drug Administration today (June 25) announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

“Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

Fayette Front Page
Georgia Front Page
Follow us on Twitter:  @GAFrontPage