Neumedicines reports that BARDA has decided to provide an additional $4.9 million under an existing contract to develop the firm's lead therapeutic, HemaMax™, as a treatment for acute radiation exposure. BARDA signed on Neumedicines last September with $3.1 million. Neumedicines stands to earn another $5 million if future options are exercised by BARDA.
The most recent round of funding was triggered by Neumedicines achieving two milestones, explains Richard A. Leon, director of communications: successful completion and outcomes of murine efficacy studies and successful development, creation, and optimization of a HemaMax-producing cell line.
The money will be used to support GMP manufacturing and efficacy studies in nonhuman primates as part of the IND. Performance under the BARDA contract is expected to fund R&D, and a Phase I trial is expected to begin in 2011.
HemaMax is based on rHuIL-12 (recombinant human interleukin-12). Scientists from Neumedicines discovered the hematological properties of IL-12 by demonstrating the potent survival effects of single, low-dose IL-12 on hematopoietic recovery following lethal radiation.
Neumedicines is developing HemaMax as a low-dose therapy that can trigger potent radiomitigation effects. In mice, it has been shown to improve survivability by 90%.
HemaMax is also being developed as a supportive care therapy in cancer. While current drugs suppress and destroy the body's blood-production capabilities, HemaMax has the potential to deliver simultaneous, recovery support of all three blood components as well as an antitumor response, according to Leon.
To date only preclinical murine studies have been conducted. "However, the BARDA program should provide significant insight into the drug's safety/tox and efficacy profile," Leon notes. "The company remains flexible in its clinical strategy, as there is a range of potential indications, some very specific and some broad. In order to support this program, the company is currently seeking approximately $7-10 million in investment, partnership, or other support."