Pasadena, California (PRWEB) August 14, 2014
Neumedicines Inc., a privately held biotechnology company focused on developing and commercializing innovative products and approaches for the treatment of various clinical indications in the areas of oncology, hematology, and immunology, announces the award of $14 million from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of the Secretary, Department of Health and Human Services (DHHS), under Contract No. HHSO100201100037C.
The award is intended to support the advanced development of HemaMax™ (recombinant human interleukin-12 or rHuIL-12) for hematopoietic syndrome of acute radiation sickness (HSARS). Specifically, the award will support a phase 2 clinical safety study of HemaMax™ in 200 healthy human volunteers, GMP manufacturing of drug product, and various other advanced development activities related to chemistry, manufacturing, and controls (CMC).
Under the U.S. FDA’s Animal Rule (21 CFR 601.90-95), Neumedicines is advancing HemaMax™ for the treatment of HSARS toward submission of applications for Emergency Use Authorization or EUA (21 U.S.C. 360bbb-3) and FDA licensure in 2015 and 2016, respectively.
“We are grateful to have now received more than $64 million from BARDA to support the development of HemaMax™ for HSARS,” said Neumedicines President & CEO Lena A. Basile, Ph.D., J.D. “Our efficacy studies have shown that a single, low-dose, subcutaneous injection of HemaMax™ at 24 hours after exposure to lethal radiation (LD70-LD90) increases survival by an average of more than 2-fold without any supportive care or antibiotics (PMIDs: 24708888 and 18489769). To our knowledge, these results are unmatched by any intervention available to the CDC’s Strategic National Stockpile or in development by industry or academia. In clinical studies, we have also show
Copyright©2014 Vocus, Inc.
All rights reserved