Humanetics Completes Phase I Safety And Pharmacokinetic Trial For New Radiation Countermeasure

Main Category: Radiology / Nuclear Medicine
Also Included In: Clinical Trials / Drug Trials
Article Date: 14 Jan 2008 - 2:00 PDT

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Humanetics Corporation announced the successful completion of the Company's Phase I human trial for BIO 300, a medical radiation countermeasure. Humanetics is seeking approval to market BIO 300 as a new drug for the prevention and mitigation of Acute Radiation Syndrome (ARS), a potentially lethal condition for which there are currently no FDA-approved treatments.

The Company reports that the clinical trial successfully met all objectives and that BIO 300 was well tolerated at all dose levels which were studied. The completion of this trial is an important milestone in the further development of the drug, which will be conducted under the FDA's Animal Efficacy Rule, eliminating the need for costly Phase III human efficacy trials and potentially speeding the drug licensing process by several years.

"Safety is the most important aspect in the development of any new drug," explained Humanetics President and CEO, Ronald Zenk. "And since BIO 300 will likely be self-administered by civilians, we must be even more diligent in assuring the safety of this drug," he added.

Humanetics has received nearly $7 million to date from the United Stated Department of Defense to continue its research into medical radiation countermeasures. In November, Humanetics was awarded $3.8 million for 2008-the largest appropriation thus far. The Company received $1.8 million from the department's FY 2007 bill and in 2006 Humanetics received $1.25 million. These funds are being used to continue development, clinical testing, regulatory approval, manufacturing and commercialization of a number of general-purpose medical radiation countermeasures. The Company's lead candidate, however, is BIO 300.

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.

BIO 300 is a single molecular agent that can be self-administered. This drug 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.

BIO 300 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 from The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., acting on behalf of USU and the NIH, to develop BIO 300 and seek FDA approval for the prevention of Acute Radiation Syndrome (ARS). ARS is a potentially fatal disease that occurs when the body receives a high dose of ionizing radiation, usually over a short period of time. Exposure to radiation causes a cascading deterioration of health leading to destruction of platelets and infection-fighting white blood cells in bone marrow.

Sources of ionizing radiation include: (i) contamination of food or water with finely powdered radioactive material than can be readily inhaled or ingested, (ii) placement of radiation material in public locations, (iii) detonation of radiological dispersal devices ("dirty bombs"), (iv) attacks on nuclear power facilities or high-level nuclear waste storage facilities, or (v) the worst possible scenario - detonation of a nuclear explosive device which, in addition to causing enormous destruction from blast and heat, would produce an intense burst of gamma radiation and large quantities of radioactive "fallout" affecting hundreds of thousands of people in the path of prevailing winds.

Over the past decade, the growing threat of terrorism has become a primary security concern in the United States and abroad. The number of known terrorist organizations with a global reach and the increased rate of proliferation and transfer of technical information through the Internet raise the possibility that attacks with radiological and nuclear weapons will occur on U.S. soil in the years to come. The situation is even more urgent overseas as tensions are building between hostile nations, many of which already have or are actively seeking nuclear weapons for targeted attacks against their neighbors using short-range missiles.

About Humanetics Corporation

Humanetics is a privately-held clinical-stage pharmaceutical company headquartered near Minneapolis, Minnesota. The Company is focused on the rapid discovery, development and commercialization of drugs for the prevention and treatment of diseases in categories with urgent and unmet needs. The Company has several proprietary compounds in preclinical and/or clinical stages of development in the areas of bioterrorism, Alzheimer's disease and obesity. For more information, visit: http://www.humaneticscorp.com.

This Press Release contains discussion of certain expectations regarding Humanetics' future performance. These forward-looking statements are based on the Company's current views and assumptions. Actual results could differ materially from these current expectations and projections, and from historical performance.

Humanetics Corporation