Pasadena, CA (PRWEB) June 08, 2011
Neumedicines, a privately held drug discovery and development company focused on innovative protein therapies for the treatment of hematopoietic deficiencies, cancer and autoimmune diseases, announced today that the company began dosing healthy volunteers in a first-in-human (FIH) Phase I study to evaluate the safety, tolerability, and pharmacokinetics of HemaMax™, its novel therapeutic for the treatment of Acute Radiation Syndrome (ARS). The IND (#104091) was filed with the U.S. Food and Drug Administration (FDA) on April 14, 2011.
HemaMax™ is being developed by Neumedicines under the FDA’s Animal Efficacy Rule to treat ARS or radiation poisoning from any exposure to radiation such as a nuclear or radiological weapon or from a nuclear accident. This approval pathway requires demonstration of efficacy in representative animal models and safety, pharmacokinetic, pharmacodynamic and biomarker testing in healthy human volunteers.
This initial safety study will involve single injections of HemaMax™ in ascending dose groups of six healthy volunteers each. Participants in the study will be assessed for adverse side effects over a four-week period and blood samples will be obtained to evaluate the effects of HemaMax™ on various biomarkers. The study is currently projected to take approximately nine months to complete and would be followed by a second, larger safety study in healthy human volunteers, prior to submission of a Biologic License Application (BLA) to the FDA. The company expects to submit its HemaMax™ BLA to the FDA by 2014.
Neumedicines received a development contract of approximately $15 million from the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (DHHS) for the advanced development of HemaMax™ as a radiation countermeasure.
The therapeutic under development by Neumedicines Inc., HemaMax™ (NMIL12-1), 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. To date, Neumedicines Inc. has demonstrated that HemaMax™ can increase survival in mice and non-human primates who receive the therapeutic in single, low doses 24 hours after lethal radiation exposure.
About Neumedicines Inc.
Neumedicines Inc. is a privately held, early-stage company developing protein therapeutics that address unmet clinical and societal needs in the fields of oncology, hematology, and immunology. The company’s lead product candidate, NMIL12-1 (recombinant human interleukin-12; rHuIL-12), functions as to target multiple pathways of hematopoiesis and innate immunity and is being developed to address a range of clinical indications. At Neumedicines, we are committed to developing and maximizing the scientific, clinical, and commercial potential of our product pipeline. Neumedicines is developing NMIL12-1 under the trade name HemaMax™ as a biodefense radiation medical countermeasure. NMIL12-1 is also being developed for indications in hematology/oncology, such as chemotherapy-induced thrombocytopenia. The company operates from its headquarters and laboratories in Pasadena, California
For more information visit: http://www.neumedicines.com
Follow Neumedicines on Twitter @Neumedicines
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
Investor and partnership inquires please contact: Dr. Lena Basile at 626-844-3800 or basile(at)neumedicines(dot)com
Media members please contact: Jeff Richardson at 805-491-8313 or jeff(at)richardsonglobalpr(dot)com
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.