Pasadena, California (PRWEB) April 18, 2014
Neumedicines Inc., a privately held biotechnology company, announced a publication presenting the clinical data from First in Human (FIH) and Phase Ib studies demonstrating the safety, tolerability, pharmacokinetics, pharmacodynamics, and hematopoietic and immune effects of HemaMax™ (recombinant human interleukin-12 or rHuIL-12). These results were published on April 11, 2014 in Experimental Hematology & Oncology in an article titled, “Single Low-dose rHuIL-12 Safely Triggers Multilineage Hematopoietic and Immune-mediated Effects.” Based on the hematopoietic and immunomodulatory activities, HemaMax™ is under development to address the unmet need for a medical countermeasure against the hematopoietic syndrome of the acute radiation syndrome (HSARS) that occurs in individuals exposed to lethal radiation, and also to serve as adjuvant therapy that could provide dual hematopoietic and immunotherapeutic benefits in cancer patients. Neumedicines studies in healthy subjects demonstrate the safety of rHuIL-12 at single, low doses that are appropriate for use as a medical countermeasure for humans exposed to lethal radiation and as an immunomodulatory anti-cancer agent.
The published FIH and phase Ib studies were conducted by Neumedicines and 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 syndrome (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 radiomitigation. The present study provides strong supportive evidence of the efficacy and safety of HemaMax™ for the treatment of HSARS.
"This study provides strong support for human safety and extensively characterizes the pharmacokinetics and pharmacodynamics of HemaMax™,” said Dr. Mamata Gokhale, Neumedicines Clinical and Regulatory Operations Director. “It takes us one step closer towards seeking approval as a radiation medical countermeasure for Emergency Use Authorization and FDA licensure under the Animal Rule. This study also sets the stage for expanding the development of HemaMax™ to support the hematopoietic system and provide immunotherapeutic benefits in cancer patients."
About HemaMax™ (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.