Novel enabling technology to enhance stem cell treatments for cancer patients
Orphan designation provides seven–year post approval marketing exclusivity, tax credits, and elimination of FDA prescription drug user fees
SAN ANTONIO, Mar. 29, 2011.
America Stem Cell, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ASC-101 to improve homing to bone marrow (treatment of myeloablation) in patients receiving hematopoietic stem cell transplantation.
“The orphan drug status confirms the importance of this new novel treatment approach to improve outcomes for patients with serious, life-threatening cancers and other disorders for which hematopoietic stem cell transplant is prescribed,” said Dr. Linda J. Paradiso, Chief Development Officer at America Stem Cell. ASC-101 will potentially transform hematopoietic stem cell transplantation by accelerating patients’ immune system and platelet recovery, reducing opportunistic infections and other co-morbidities, and possibly improving patient survival.
The FDA orphan drug designation will confer America Stem financial benefits and incentives, such as potential Orphan Drug grant funding to defray the cost of clinical testing, tax credits for the costs of clinical research, seven–year period of exclusive marketing after approval and Waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
“This recognition of orphan drug status for ASC-101 by the FDA together with a strong proprietary intellectual property portfolio, positive preclinical proof of principle data and our completion of GLP toxicology and cGMP clinical product manufacturing points to the strong potential for America Stem Cell to transform clinical outcomes for these advanced cancer patients,” said Lynnet Koh, Founder, CEO and Chairman of the Board of America Stem Cell.
America Stem Cell is poised to commence a Phase I/IIa clinical trial for the treatment of advanced hematological cancers at the University of Texas MD Anderson Cancer Center in Houston.