Tread Carefully On This News Print E-mail
By Staff and Wire Reports   
Tuesday, 21 September 2010 07:08

At the beginning of September, we told you that Athersys Inc. (NASDAQ:ATHX) had been on the rise and that subscribers needed to be in the know about possible developments there.

Today, the  Company announced today that its multipotent adult progenitor stem cell therapy MultiStem®, has been granted orphan drug designation by the U. S. Food and Drug Administration for the prevention of graft vs. host disease (GvHD). GvHD is a common condition associated with a bone marrow transplant in which immune cells in the transplanted marrow recognize the transplant recipient as foreign and mount an immunologic attack.

"We are extremely pleased to have been granted the benefits of orphan drug designation as we continue to advance this program in our ongoing clinical studies," said Deborah Ladenheim, Ph.D., Vice President of Regulatory Affairs of Athersys. "Complications, such as GvHD, associated with current treatment approaches to leukemia and other blood born cancers represent a significant unmet medical need. Because of MultiStem's consistent safety profile, potential for off-the-shelf administration, and multiple mechanisms of action, we feel this program could help effectively address the needs of this patient community."

MultiStem is currently in a phase 1 clinical trial to evaluate the safety of administration in support of bone marrow transplantation for the treatment of certain cancers of the blood and immune system, where GvHD is a common complication. Orphan drug designation, which is intended to facilitate drug development, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, tax incentives and seven years of market exclusivity for the product upon regulatory approval.

While we pondered two weeks ago whether buying shares of the company could lead to a good trade, our Patrick Crutcher was of the opinion that given how early the clinical development of MultiStem is, it might be a better idea to wait. "Maybe after they have Phase 2 trials underway would I reconsider," wrote Crutcher. "Also keep in mind that ATHX still has 20M share shelf that hasn’t been used yet."

Be careful about jumping on too quickly on this news, as dillution could follow.

Read the original report here: http://biomedreports.com/articles/most-popular/52578-athersys-nasdaqathx-now-a-buy-or-not.html




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