Pasadena, CA (PRWEB) April 15, 2014
Neumedicines Inc., a privately held biotechnology company, announced that in a randomized, blinded, placebo controlled GLP phase II-equivalent study under the FDA Animal Rule, HemaMax™ (recombinant human interleukin-12 or rHuIL-12) treatment led to statistically significant survival and reduction of radiation-induced hematopoietic toxicity and infections in non-human primates when administered as a single low dose 24-25 hours after exposure to total body lethal radiation. Survival benefit was 22%, 28%, 28%, and 39% for 50, 100, 250, and 500 ng/kg dose of HemaMax™, respectively (log rank p < 0.05 for each dose vs. control). HemaMax™ also significantly reduced the incidences of severe neutropenia, severe thrombocytopenia, and sepsis (positive hemoculture). Additionally, bone marrow regeneration following TBI was significantly greater in monkeys treated with HemaMax™ than in controls. These results were achieved in the absence of any supportive care, including antibiotics, fluids, or transfusions, and were published on April 6, 2014 in Journal of Hematology & Oncology in an article titled, “Randomized Comparison of Single Dose of Recombinant Human IL-12 versus Placebo for Restoration of Hematopoiesis and Improved Survival in Rhesus Monkeys Exposed to Lethal Radiation.”
HemaMax™ is being developed by Neumedicines as a prophylactic and frontline post-exposure therapeutic for the treatment of Acute Radiation Syndrome under FDA’s Animal Rule (21 CFR 601.90-95). The published phase II-equivalent study, conducted by Neumedicines, was funded by the Biomedical Advanced Research & Development Authority (BARDA) of the U.S. Department of Health and Human Services (DHHS) as part of its ongoing support of the development of HemaMax™ for the treatment of hematopoietic syndrome of acute radiation sickness (HSARS).
Phase III-equivalent development under FDA’s Animal Rule (21 CFR 601.90-95), including expanding current safety studies in humans and a pivotal efficacy study in non-human primates, is planned over the next 2 years (2014-2015) in order to provide sufficient data required to support applications for Emergency Use Authorization (21 U.S.C. 360bbb-3) and a Biologics License Application (BLA), which are anticipated in 2015 and 2016, respectively. Currently, there is no FDA-approved drug for HSARS mitigation. The present study provides strong supportive evidence of the efficacy and safety of HemaMax™ for the treatment of HSARS.
“The data from this randomized, blinded, placebo-controlled study demonstrate a significant effect of a single, subcutaneous injection of HemaMax™, over a 10-fold dose range (50-500ng/kg), on survival following lethal TBI in the rhesus monkey model of HSARS,” said Dr. Zoya Gluzman-Poltorak, Neumedicines Senior Nonclinical Director. “Notably, there was no statistically significant difference in the survival rate among various HemaMax-treated groups (e.g., 50 and 500 ng/kg). Translation of the efficacious and safe dose from an animal model to humans is a significant challenge for any drug development program under the FDA Animal Rule. Thus, our finding that statistically significant increases in survival can be achieved over a ten-fold effective dose range of HemaMax™ in the rhesus monkey model will provide a distinct advantage for optimal human dose selection.”
About HemaMax™ (recombinant human interleukin-12 or rHuIL-12)
HemaMax™ (rHuIL-12) holds considerable value and promise playing a central role in linking and regulating both innate (early nonspecific) and adaptive (late specific) immunity while also playing a critical role in hematopoietic cell-to-cell signaling. In addition to HSARS, HemaMax™ is also being developed for various indications in oncology, including cutaneous T cell lymphoma (CTCL), acute myeloid leukemia (AML), melanoma, solid tumors, various immunotherapy applications, and hematopoietic support.
About Neumedicines Inc.
Neumedicines Inc., a California corporation, is an emerging therapeutic biotechnology company focused on developing and commercializing innovative and proprietary products and approaches for the treatment of various clinical indications that address unmet clinical and societal needs in the fields of oncology, hematology, and immunology. The company operates from its headquarters and laboratories in Pasadena, California.
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
About Hematopoietic Syndrome of Acute Radiation Sickness (HSARS)
Acute Radiation Syndrome (ARS) (sometimes known as radiation toxicity or radiation sickness) is an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a very short period of time (usually a matter of minutes). The major cause of this syndrome is depletion of immature parenchymal stem cells in specific tissues. Examples of people who suffered from ARS are the survivors of the Hiroshima and Nagasaki atomic bombs, the firefighters that first responded after the Chernobyl Nuclear Power Plant event in 1986, and some unintentional exposures to sterilization irradiators.
There are three classic ARS sub-syndromes: 1) Hematopoietic, 2) Gastrointestinal (GI), and 3) Cardiovascular (CV) / Central Nervous System (CNS). The hematopoietic syndrome (sometimes referred to as bone marrow syndrome) will usually occur with a dose between 0.7 and 10 Gy (70 – 1000 rads), though mild symptoms may occur as low as 0.3 Gy or 30 rads. The survival rate of patients with this syndrome decreases with increasing dose. The primary cause of death is the destruction of the bone marrow, resulting in deficiencies of white blood cells (WBCs), lymphocytes, and platelets, with immunodeficiency, increased infectious complications, bleeding and hemorrhage, anemia, and impaired wound healing.
This press release contains certain forward-looking statements relating to our business. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs. There can be no assurance that any product in Neumedicines pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.