HATFIELD, England, August 22, 2012 /PRNewswire/ -- Results of longer term safety and efficacy study also released Results from the final pivotal Phase III study and long term Phase III extension study Fycompa(R) (perampanel), were published online today in Epilepsia(R). Findings from Study 305, one of three pivotal global studies, and the extension study for perampanel add further weight to the growing body of clinical evidence supporting the efficacy and safety of the new treatment.[1,2] Perampanel is the only licensed anti-epileptic drug in Europe that selectively targets AMPA receptors, which are thought to play a central role in seizure generation and spread.[3] This first in class treatment selectively targets the transmission of seizures by blocking the effects of glutamate, which can trigger and maintain seizures. The 305 study demonstrated that once-daily, adjunctive perampanel improved seizure control and was acceptably-tolerated in subjects 12 years and older with refractory partial-onset seizures. Study 305 is one of three pivotal Phase III studies in the EXPLORE (EXamining PerampaneL Observations from Research Experience) clinical trial programme.[1] Showing consistency with other results from the Phase III clinical trial programmes, the 307 interim results showed that perampanel had an acceptable tolerability profile in patients with refractory partial-onset … Continue reading →

Colorado State University veterinarians are looking for cats with chronic kidney disease to participate in a clinical trial involving stem cell therapy. Felines with chronic kidney disease may benefit from the clinical trial. Kidney disease, or renal failure, is a highly common ailment particularly in older cats. Currently, other than kidney transplantation, only supportive care home treatments are available to try and slow the progression of the disease. Recent studies have shown that stem cell therapy has the potential to improve kidney function in rodents with kidney failure. In laboratories, stem cells improve renal function, decrease inflammation and scarring in the kidney and improve levels of excess protein in the urine. What the study involves: Stem cells that have been grown from the fat of young healthy specific-pathogen free cats (the cats are not harmed during the collection process) will be slowly injected intravenously every two weeks for three treatments. A small group of cats will receive a placebo treatment during the trial, but have the option to receive stem cell treatment after finishing the trial. The study involves a minimum of five visits to the Veterinary Teaching Hospital, so cats that are stressed or become agitated during veterinary visits, … Continue reading →

SACRAMENTO, Calif., Aug.21, 2012 /PRNewswire/ -- Sutter Neuroscience Institute, a recognized Center of Excellence, and CBR (Cord Blood Registry), the world's largest stem cell bank, are launching the first FDA-approved clinical trial to assess the use of a child's own cord blood stem cells to treat select patients with autism. This first-of-its-kind placebo controlled study will evaluate the ability of an infusion of cord blood stem cells to help improve language and behavior. The study is in conjunction with the Sutter Institute for Medical Research. To view the multimedia assets associated with this release, please visit: http://www.multivu.com/mnr/57707-cord-blood-registry-stem-cell-trials-child-autism (Photo:http://photos.prnewswire.com/prnh/20120821/MM59477) (Logo:http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO) According to the Centers for Disease Control and Prevention, autism spectrum disorders impact one in 88 children in the U.S., and one in 54 boys.1 The condition is thought to have multiple risk factors including genetic, environmental and immunological components. "This is the start of a new age of research in stem cell therapies for chronic diseases such as autism, and a natural step to determine whether patients receive some benefit from an infusion of their own cord blood stem cells," said Michael Chez, M.D., director of Pediatric Neurology with the Sutter Neuroscience and principal study investigator. "I will focus on … Continue reading →

ScienceDaily (Aug. 17, 2012) Stress urinary incontinence (SUI) can occur due to sneezing, coughing, exercising or even laughing and happens because the pelvic floor muscles are too weak causing leakage when the bladder is put under pressure. New research published in BioMed Central's open access journal BMC Medicine shows that a new technique, using stem cells isolated from amniotic fluid, can regenerate damaged urethral sphincter muscles and prevent pressure incontinence in mice. Although SUI is more common during and after pregnancy, and after the age of 40, one in three women will experience it at some point in their lives. Men can also be affected, especially after prostate surgery. SUI is treatable and in many cases losing weight, reducing caffeine intake, pelvic floor exercises, and bladder training can have very beneficial effects. If this does not work more invasive treatments are necessary, however there can be serious side effects associated with surgery. Using stem cells to regenerate the damaged or weak muscles has been proposed as an alternative to surgery. But most protocols for harvesting stem cells also require invasive procedures, and often produce very low numbers of viable cells. In contrast amniotic stem cells can be collected easily, and … Continue reading →

By Ryan Flinn - 2012-08-21T04:01:00Z Researchers are recruiting autistic children for a study that will test whether injecting stem cells banked from their umbilical cords can lessen symptoms and provide insights into the nature of the disorder. While stem cells have been promoted, and sold, as a treatment for autism, few clinical trials have been conducted to see whether theyre effective. The study, which begins enrolling patients today, is the first of its kind approved by the U.S. Food and Drug Administration to assess the use of stem cells as a potential autism therapy, said Michael Chez, director of pediatric neurology at Sutter Medical Center in Sacramento, California, and the principal investigator. About 1 in 88 children in the U.S. are diagnosed with an autism-related condition. The disorder hurts brain development and is linked to poor social interaction and communication skills, repeated body movements, and unusual attachments to objects. With this study well be able to answer in a firm way that this is truly an observed effect, or we didnt get an observed effect, Chez said in a phone interview. Thirty children with autism, ages 2 to 7, will be divided in two groups, with one getting the stem … Continue reading →

Researchers at Penn State College of Medicine are focusing on a technology that could deliver cancer treatments directly to tiny cells without affecting other cells. Currently, chemotherapy is a broad treatment that affects both benign and malignant cells. Current cancer fighting drugs are limited by the inability of the medicine to get efficiently into the cancer cells, without affecting other normal growing cells," lead researcher Mark Kester said in a statement. Kester, director of Penn State Center for NanoMedicine and Materials, has developed a Nanojacket technology that targets a gene mutation in women with advanced cases of breast cancer. Not only does the new technology target a smaller area, it can be adjusted to fit patients specific gene mutations. One aspect of personalized medicine is identifying genetic mutations in individual cancer patients, as opposed to a one size fits all approach, Kester said. Nanotechnology enables the therapeutic targeting of these mutations. Kester and his co-investigator, James Adair of Penn States Department of Material Sciences and Engineering, has received a $1 million grant that will be used to conduct trials preparatory to seeking approval from the federal Food and Drug Administration. Kester and Adair are co-founders and chief medical officer and … Continue reading →