In its Phase II study, Athersys has involved 140 patients and is being conducted at several leading stroke centers across the U.S. In October of last year, the company announced the successful completion of the first two dosing cohorts for trial. Both dose levels were shown to be safe and well tolerated. Results from this final portion of this study are expected within the next 12 months.
The third area of clinical development for Athersys involves GvHD, an imbalance of immune system function caused by transplanted cells that attack various tissues and organs. In early 2012 Athersys announced successful completion of a Phase I clinical study involving administration of MultiStem to patients suffering from leukemia or certain other blood-born cancers that undergo radiation therapy and then receive a hematopoietic stem cell transplant. Such patients are at significant risk for serious complications, including GvHD. Phase I of Athersys's study was completed in early 2012 for patients suffering from leukemia and other blood-born cancers. In the highest single dose group "no cases of severe GVHD were observed and there was only one moderate grade (grade 2) that resolved with treatment."
Athersys believes there is strong rationale to support the accelerated development of MultiStem for the prevention of GvHD. In April 2012, it met with the FDA to discuss the clinical path. The company is currently defining the detailed clinical plan for an upcoming double blind, placebo controlled phase II/III study. With these preparations taking place now, the submission to the FDA for these trials should be imminent.
When the submission of this Phase II/III happens, it should put more of an emphasis on the potential success story Athersys is starting to develop into. In addition, this could lead to additional partnerships along with the one already established with Pfizer. This would lead to more up-front and developmental cash payments. If Athersys can prove its worth along the way to Pfizer and other high level pharmas, the potential would be very high for the company and related stock price.
Perhaps the biggest speculative value driver for Athersys is ATH-9I385, a 5HT2c receptor agonist the company is developing in its pipeline. This receptor is a key for assisting the brain in regulating appetite and food intake that is effective for the treatment of obesity and diabetes.
In 2012, for the first time in over 13 years, 2 companies had their anti-obesity drugs approved by the FDA.
Arena Pharmaceuticals, Inc had its drug Belviq approved in June of 2012, While VIVUS, Inc. had its drug Qsymia approved in July of the same year.
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