Osiris Therapeutics announced that it has been awarded a $224.7 million contract, including purchase options, from the United States Department of Defense (DOD) to develop and stockpile Prochymal, an adult stem cell therapy, for the repair of gastrointestinal injury resulting from radiation exposure.
Under the terms of the contract, the DOD will provide funding to Osiris for the development of Prochymal for acute radiation syndrome (ARS) in two stages, with an initial amount of $4.2 million in 2008. Upon Food and Drug Administration approval for ARS, the contract provides for the purchase of up to 20,000 doses, at $10,000 per dose, of Prochymal in four 5,000-dose increments. Prochymal was selected by the DOD as part of an open and competitive solicitation with pre-specified criteria that included safety and efficacy data, manufacturing capacity, soundness of the development plan, and time to final product delivery.
"We are honored that the Department of Defense has selected Prochymal in this critical effort to better safeguard our armed forces against the potentially horrendous effects of battlefield exposure to a radiological weapon,” said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. “The contract also brings into focus a substantial new market opportunity for Prochymal. We are working diligently towards licensure of Prochymal for ARS and stand ready to assist other sectors of the United States government and allied nations in their emergency preparedness efforts.”
“Prochymal’s unique mechanism of action and strong clinical profile make it very well suited to address the complicated injuries associated with ARS,” said Major General John Parker, MD, (Ret.), former Commanding General responsible for countermeasure development and acquisition, and member of Osiris’ Medical Countermeasure Advisory Board. “Currently, every scenario contemplating a radiological emergency, both civilian and military, involves people suffering from the life-threatening effects of ARS without effective treatments. Today’s decision by DOD sets in motion a sound plan to change that, by expeditiously completing development of the first effective therapy for ARS.”
Osiris and Genzyme Corporation recently announced an agreement to jointly develop Prochymal for use by U.S. and allied nations for emergency preparedness. The Department of Defense decision to fund Prochymal marks the first award under this new partnership.
“We are pleased to partner with Osiris in developing this innovative cell therapy to treat the potentially lethal complications of ARS for the U.S. military,” said Henri A. Termeer, Chairman and Chief Executive Officer of Genzyme Corporation. “With our combined first-in-class technology and development expertise, Osiris and Genzyme have the necessary resources to complete this assignment for the Department of Defense and to work with other governmental organizations committed to safeguarding our nation and its allies.”
Prochymal is currently in Phase III clinical trials for the treatment of graft vs. host disease and Crohn's Disease and a Phase II trial for type 1 diabetes. Prochymal has also demonstrated preliminary efficacy in the treatment of patients experiencing heart attacks. Prochymal has demonstrated a strong safety profile in 7 previous Phase I and II trials and has shown the potential to reverse cellular damage and improve survival in disease states similar to ARS.
“Prochymal represents a breakthrough in countermeasure development for ARS,” said Thomas J. MacVittie, Ph.D., Professor of Radiation Oncology and Pathology at the University of Maryland and member of the NIAID Medical Countermeasures and CDC Strategic National Stockpile Radiation Working Groups. “Prochymal has demonstrated therapeutic utility in humans repairing many of the major organ systems affected by radiation injury. Where most approaches only target a single component of ARS, Prochymal has the potential to address the entire syndrome including both acute and delayed effects in multiple organ systems.” Dr. MacVittie also serves as a member of Osiris’ Medical Countermeasure Advisory Board.
About Acute Radiation Syndrome
Acute Radiation Syndrome (ARS) involves damage to DNA predominately affecting the rapidly dividing cells of the gastrointestinal (GI) tract, skin, and the bone marrow. The clinical manifestation of ARS can be divided into four distinct stages: prodrome, latency, manifest illness, and recovery or death. Typically, the prodromal phase consists of GI symptoms that include abdominal pain, nausea, vomiting, and diarrhea lasting 2 to 6 days. Depending on exposure, during the latent phase there is a brief abatement of symptoms as the patient appears to recover from the initial illness. However, within days to weeks, a hematopoietic (blood-forming) crisis ensues as a consequence of the depletion of both white blood cell and red blood cell progenitors within the bone marrow. The manifest illness is characterized by immunosuppression, fever, and diarrhea. Victims can die within days to several months following initial exposure.
Illustration: Osiris Therapeutics.
Osiris Therapeutics Press Release (01/03/08)
Business Wire (01/03/08)
Genetic Engineering & Biotechnology News (01/03/08)
United Press International (01/04/08)
Washington Post (01/07/08)