January 11, 2007
FDA Clears Humanetics’ IND Filing to Commence Clinical Studies on New Radiation Countermeasure
Drug Would Be Self-Administered, Likely Representing First Practical Protection for Millions of Americans
MINNEAPOLIS-January 11, 2007--Humanetics Corporation today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s request to begin Phase I human trials under an Investigational New Drug (IND) application for BIO 300, a radiation countermeasure. Humanetics is seeking approval to market BIO 300 as a new oral drug for the prevention and prophylactic treatment of Acute Radiation Syndrome (ARS).
ARS is a potentially lethal condition that may be caused by whole-body exposure to radiation resulting from a nuclear or radiological terrorist attack or from an accident at a nuclear facility. Exposure to radiation causes injury to bone marrow, resulting in decreased production of platelets and infection-fighting white blood cells. Currently, there are no drugs approved by the FDA for the prevention or treatment of ARS.
BIO 300 is a single molecular agent that can be self-administered. This oral drug, when taken prophylactically, has the potential to ameliorate the effects of ARS-related damage including damage to progenitors of platelets and infection-fighting white blood cells in bone marrow resulting in reduced morbidity and mortality. BIO 300 may achieve this effect through several mechanisms of action.
"FDA clearance to begin human trials under our IND is an important milestone in our commitment to develop BIO 300 as the first practical solution for the protection of mass civilian populations," stated Ronald Zenk, President and CEO of Humanetics. "We are delighted to have this opportunity to develop and commercialize a new drug discovered by federal researchers to help safeguard our nation.”
The ability of BIO 300 to protect against radiation-induced lethality was discovered by researchers at the Armed Forces Radiobiology Research Institute (AFRRI), a research institute within the Uniformed Services University of the Health Sciences (USU); and the National Institutes of Health (NIH). Humanetics obtained a worldwide exclusive license to commercialize BIO 300 from The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF), acting on behalf of USU and the NIH. The USU is a Congressionally-chartered, fully-accredited, graduate education university operated by the Department of Defense. HJF, in Rockville, Maryland, is a private, not-for-profit organization authorized by Congress to support medical education and research at USU and throughout the military medical community.
Humanetics has been working with researchers at AFRRI for several years to develop BIO 300 and other safe, effective agents to prevent and treat ARS. A primary focus of the Company’s work with AFRRI is the development of orally effective compounds that can be self-administered by mass military and civilian populations. AFRRI, located in Bethesda, Maryland, is recognized as the nation’s premier center for radiation injury countermeasure research.
In 2003, the White House Office of Science and Technology Policy and the Homeland Security Council, through an interagency working group called the Weapons of Mass Destruction Medical Countermeasures Subcommittee, established a priority list of radiological nuclear threat countermeasures. Each countermeasure on the list was assigned one of four priorities: “Top,” “High,” “Medium” and “Low.” Radioprotectants for use prior to exposure to radiation were assigned the Top priority. The Subcommittee further specified that ideally, such countermeasures would be easily administered, preferably orally, and would have low toxicity. BIO 300 is being developed by Humanetics as the preferred oral formulation for a radioprotectant and would qualify as a Top priority as defined by the Subcommittee.