Pasadena, CA (PRWEB) August 16, 2010
Neumedicines Inc. today announced that the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) exercised the third milestone-based option on the Company's existing contract with BARDA to develop Neumedicines’ lead therapeutic, HemaMax™, as a treatment for acute radiation exposure. The third milestone-based option was exercised based on successful completion of a non-human primate proof-of-concept study and is valued at $2.46 million, bringing the total funding provided thus far by BARDA to $10.51 million. The total contract award including the base contract and all options, if exercised, is projected to yield approximately $13 million for the initial development phase of HemaMax™ as a radiomitigator.
Funds under this option will be used to support toxicology and safety studies in non-human primates as part of the Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). Performance under the BARDA contract is expected to fund research and development culminating in an IND submission in Q1-2011 to be followed by a subsequent option for first-in-human, Phase I clinical safety trial for HemaMax™.
"HemaMax has previously been shown to be a potent radiation countermeasure in mice. And now, the potent effects of HemaMax have been further demonstrated in non-human primates, allowing Neumedicines to achieve a key milestone in the development of HemaMax as a radiomitigator of the hematopoietic syndrome of acute radiation syndrome. We believe that HemaMax has unique properties that will render it to be a very significant therapeutic in many clinical areas related to hematology and oncology,” says Lena A. Basile, Ph.D., J.D., President & CEO of Neumedicines.
The therapeutic under development by Neumedicines Inc., HemaMax™, is based on rhuIL-12 (recombinant human Interleukin–12). Scientists from Neumedicines discovered the previously unexplored hematological properties of IL-12 by demonstrating the potent survival effects of single, low dose IL-12 on hematopoietic recovery following lethal radiation. HemaMax™ is a new therapeutic that can be administered in very low, nanogram doses to achieve potent radiomitigation effects. Neumedicines Inc. has to date demonstrated that HemaMax™ can increase survival in mice and non-human primates administered HemaMax™ in single, low doses 24 hours after lethal radiation exposure.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
BARDA manages Project BioShield, which includes the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases that fall outside the auspices of Project BioShield. In addition, BARDA manages the Public Health Emergency Countermeasures Enterprise (PHEMCE).
For more information visit: http://www.medicalcountermeasures.gov
About Neumedicines Inc.
Neumedicines, Inc. was founded in 2003 as a start-up company from the University of Southern California (USC) and is engaged in research and development of both prophylactics and therapeutics based on Interleukin-12 (IL-12) (HemaMax™) for the mitigation and reversal of radiological (myeloablative) and myelosuppressive effects on the human hematopoietic system. In animal tumor models, HemaMax™ has been shown to be effective in restoring hematopoiesis following either radiation or chemotherapy, while providing concomitant anti-tumor effects over and above the primary therapy. Thus, clinical applications for HemaMax™ are also being pursued in hematology and oncology. Another oncology therapeutic in preclinical development is HSS1, a novel secreted protein with anti-tumor effects in glioma.
For more information visit: http://www.neumedicines.com
Media Contact: Neumedicines Inc. Richard Leon, Director of Communications (281) 813-4631 leon(at)neumedicines(dot)com.