Radiation risksNeumedicines receives $14m for acute radiation exposure countermeasures
Neumedicines receives $14 million from BARDA to support advanced development of HemaMax, including advanced GMP manufacturing activities and a Phase 2 clinical safety study in 200 healthy human volunteers. The company says its efficacy studies have shown that a single, low-dose, subcutaneous injection of HemaMax at twenty-four hours after exposure to lethal radiation increases survival by an average of more than 2-fold without any supportive care or antibiotics.
Neumedicines Inc. said it has received an 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).
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.
Neumedicines president & CEO Lena A. Basile said that Neumedicines has now received more than $64 million from BARDA to support the development of HemaMax for HSARS. She noted that the company’s efficacy studies have shown that a single, low-dose, subcutaneous injection of HemaMax at twenty-four 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 CDCs Strategic National Stockpile or in development by industry or academia,” the company said, adding that in clinical studies, HemaMax has proven safe in healthy volunteers.
Basile said that with BARDAs continued funding, the company is advancing HemaMax toward consideration for EUA, which, if granted, would allow for its use in the event of a radiological/nuclear emergency. “We believe HemaMax could have a significant impact in saving lives in such an event, and our team is committed to advancing HemaMax so that it may soon be a component of the United States arsenal in countering radiological/nuclear emergencies,” Basile added.
The company notes that research and development of HemaMax for HSARS has been funded entirely with federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, and the Department of Health and Human Services.
