BARDA awards $14 million to Neumedicines to develop radiation countermeasure
HemaMax, also known as recombinant human interleukin-12 (rHuIL-12), is a medical countermeasure candidate for hematopoietic syndrome of acute radiation syndrome (HSARS). The BARDA award will support a Phase II clinical safety study of HemaMax, manufacturing of a drug product and other advanced development activities.
"We are grateful to have now received more than $64 million from BARDA to support the development of HemaMax for HSARS," Lena Basile, the president and CEO of Neumedicines, said. "Our efficacy studies have shown that a single, low-dose, subcutaneous injection of HemaMax at 24 hours after exposure to lethal radiation increases survival by an average of more than two-fold without any supportive care or antibiotics. To our knowledge, these results are unmatched by any intervention available to the (Center for Disease Control and Prevention's) Strategic National Stockpile or in development by industry or academia. In clinical studies, we have also shown that HemaMax is safe in healthy volunteers."
Neumedicines is advancing HemaMax for the treatment of HSARS toward the submission of applications for emergency use authorization (EAU) in 2015 under the Food and Drug Administration's Animal Rule. The company is also seeking FDA licensure in 2016.
"With BARDA's continued funding, we are advancing HemaMax toward consideration for EUA, which, if granted, would allow for its use in the event of a radiological/nuclear emergency," Basile said. "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."
Neumedicines develops products and approaches for the treatment of clinical indications that address unmet clinical and societal needs.