Neumedicines, Inc. announced today that it has been awarded approximately $2.5 million by the Department of Defense, Defense Medical Research and Development Program, for a clinical trial assessing the safety and efficacy of NM-IL-12 (aka HemaMax) (recombinant human interleukin-12 or rHuIL-12) as a prophylactic immunotherapy in surgical wounds, for the purpose of avoiding infection by way of a mechanism different from all antibiotics. The trial is a Phase IIa study involving approximately 30 subjects and is expected to be concluded in mid-2016.
“We’re pleased to undertake this effort for the U.S. military,” said Neumedicines’ President and CEO Lena A. Basile, Ph.D., J.D. “Our study will focus on combating multi-drug-resistant bacterial and fungal pathogens that are evolving threats to wounded service men and women. Moreover, these pathogenic threats prevent robust healing. Our studies of IL-12 in preclinical models demonstrated significantly accelerated wound healing. Our subjects will be drawn from patients who have undergone abdominal surgery and who also present with the finding of contamination at the surgical wound site.”
Prior to receiving this DOD award, Neumedicines has received more than $64 million from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to support the development of HemaMax for the treatment of hematopoietic syndrome of acute radiation sickness (HSARS). Sometimes known as radiation toxicity or sickness, HSARS results from exposure to a high dose of ionizing radiation as would happen in the case of a nuclear attack, and causes depletion of progenitor and stem cells in specific tissues of those exposed to the radiation. It is particularly harmful to blood cell-producing bone marrow, and can be fatal. BARDA has supported much of the pre-clinical, nonclinical and clinical studies resulting in Neumedicines’ pursuit of FDA approval for HemaMax for radiomitigation.
“Receiving this Department of Defense Military Infectious Diseases Clinic Trial Award is another important recognition of HemaMax’ potential range of applications,” said Basile. “The drug plays a critical role in hematopoietic cell-to-cell signaling, stimulating immunity and hematopoiesis, and therefore should be valuable for a variety of oncology indications, including cutaneous T-cell lymphoma, acute myeloid leukemia, melanoma, and solid tumors, which are often treated with radiation and/or chemotherapy that yield undesirable hematopoietic and immunological side effects. In other words, HemaMax may be a safe and effective way to treat many conditions that suppress the body’s ability to generate blood cells and stave off infections, and that is the reason for its appeal to the military.”
About Neumedicines Inc.:
Privately-held Neumedicines is an emerging therapeutic biotechnology company that is developing and commercializing innovative, proprietary products and approaches for the treatment of various clinical indications in the fields of oncology, hematology, and immunology. The company’s headquarters and laboratories are located in Pasadena, California. For more information, please visit www.neumedicines.com.
About the Department of Defense, Defense Medical Research and Development Program:
The program’s efforts help to fulfill the Defense Health Program priority to advance medical research and development for wounded warriors and expedite the delivery of products and solutions to service members and their families and advance the state of medical science in areas of the most pressing need. More information is available on website: http://cdmrp.army.mil/dmrdp/default.shtml.
About Biomedical Advanced Research & Development Authority (BARDA):
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.