July 20, 2007
Humanetics Receives Orphan Drug Designation for Its BIO 300 Radiation Countermeasure
BIO 300 is first radiation protection drug granted orphan designation by FDA
MINNEAPOLIS, MN, July 20, 2007--Humanetics Corporation, a privately held pharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to its BIO 300 investigational drug for the prevention of Acute Radiation Syndrome (ARS). BIO 300 is being developed as a medical countermeasure for ionizing radiation resulting from a nuclear or radiological attack, act of terrorism or accident. It is the first and, to date, only drug to receive orphan designation for the prevention of ARS.
The U.S. Orphan Drug Act is intended to encourage companies to develop safe and effective therapies for the treatment of rare diseases and conditions. Orphan drug designation provides significant benefits such as seven-years of market exclusivity upon approval for the specific compound and indication, tax credits for product development, reduced fees for market applications and assistance from the Division of Orphan Products within FDA to help move the drug through the approval process.
Humanetics’ development of BIO 300 is in response to the United States Military and Government’s urgent desire to identify and procure medical countermeasures for ARS to protect and treat members of the military, first responders and the civilian public which may be the targets of a radiological or nuclear event. This urgency is highlighted by the fact that there are no drugs approved in the United States to prevent or treat radiation injury.
According to Ronald J. Zenk, President and CEO of Humanetics, “Based on our preclinical work on BIO 300 with the Department of Defense (DOD), we are confident it will be a safe and practical countermeasure for ARS. Our research shows multiple benefits of BIO 300 over other potential therapies including oral administration, enhanced safety with lower risk of side effects, stability and ease of storage and distribution: making it an ideal product to protect large populations in the event of an accidental or terrorist nuclear incident,” he explained.
Collaboration with Department of Defense (DOD)
Studies on BIO 300 have been conducted under a Cooperative Research and Development Agreement (CRADA) with the Armed Forces Radiobiology Research Institute (AFRRI), a research institute within the Uniformed Services University of the Health Sciences (USU), a fully accredited graduate education university within the DOD, and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF). HFJ 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 an exclusive worldwide license from the United States of America for patents covering the use of BIO 300 as a radiation countermeasure.
About BIO 300
BIO 300 is a small, single molecular agent for the treatment of ARS and is in a class of drugs known as medical radiation countermeasures. Medical radiation countermeasures are used in the event of, or threat of, a radiation or nuclear event caused by terrorism or accident. BIO 300 has shown efficacy in multiple animal species and has a significant body of safety data in both animals and humans. The mechanism of action through which it achieves this effect involves multiple factors such as stimulation of hematopoietic cell growth and differentiation, inhibition of protein tyrosine kinase-triggered apoptosis, anti-inflammatory effects and potent antioxidant activity. BIO 300 is being developed under an Investigation New Drug Application granted in December of 2006. Human and animal trials are on-going.
About Acute Radiation Syndrome
RS is a serious illness that occurs when the body receives a high dose of partial or full body ionizing radiation, usually over a short period of time. Many survivors of the Hiroshima and Nagasaki atomic bombs in the 1940s and many of the firefighters who first responded after the Chernobyl Nuclear Power Plant accident in 1986 became ill with ARS. It is a syndrome that affects multiple organ systems, with profound effects on the rapidly dividing cells of the bone marrow and intestinal tract with further late effects to the lungs and other vital organs. The primary cause of death during the early phase of ARS involving full body exposure to radiation is sepsis resulting from opportunistic infection due to a decline in infection fighting cells known as neutrophils, which are normally made by the bone marrow. The principal cause of death resulting from partial body exposure to radiation is damage to vital organs, including severe inflammation of lung tissue. The chance of survival for people with ARS decreases with increasing radiation dose. Most people who do not recover from ARS will die within several months of exposure. For the survivors, the recovery process may last from several weeks up to two years.