Pasadena-based Neumedicines Inc. has reportedly received $8.3 million from the Biomedical Advanced Research & Development Authority (BARDA) of the U.S. Department of Health and Human Services to continue development of HemaMax™ (recombinant human interleukin 12 or rHuIL-12) for hematopoietic syndrome of acute radiation sickness (HSARS). Neumedicines evidently plans to submit HemaMax™ for a Biologic License Application (BLA) under the U.S. Food and Drug Administration’s Animal Rule (21 C.F.R. 601.90-95) for the treatment of HSARS and will use the funds to conduct animal studies comparing the effectiveness of HemaMax™ with granulocyte colony-stimulating factor (G-CSF) as well as assess the effectiveness of a combination of HemaMax™ and G-CSF as a treatment for HSARS.
“We have now received more than $50 million from BARDA to support the development of HemaMax™ for HSARS,” said Neumedicines President and CEO Lena Basile. “Our studies in non-human primates have shown that a single, low-dose, subcutaneous injection of HemaMax™ at 24 hours after exposure to lethal amounts of radiation (LD90) increased survival by up to 40%, without any supportive care or antibiotics. We also have shown in first-in-human and Phase 1b studies that HemaMax™ at a dose equivalent to the efficacious nonhuman primate dose is safe in healthy volunteers.”
Basile reported that Neumedicines also intends to use the funds to explore the use of HemaMax™ on a pre-emergency use authorization basis and to develop it as a hematological adjuvant therapy for cancer patients. “HemaMax™ provides concomitant anti-infectivity and anti-tumor responses that are additive to the primary cancer therapy. We don’t know of any other drug with these multifunctional properties,” said Basile. See BusinessWire.com, June 10, 2013.