Humanetics' BIO 300 medical radiation countermeasure drug candidate issued U.S. patent

In an announcement today, Humanetics Corporation reported that its BIO 300 medical radiation countermeasure drug candidate has been issued a U.S. patent. The patent is assigned to the United States of America with Humanetics as the designated licensee.

“We are pleased that BIO 300 has reached this critical milestone”

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 NIH, for patents covering the use of BIO 300 as a medical radiation countermeasure. Patents protecting BIO 300 have now been issued in the United States, Europe and Australia - with others pending in Japan and Canada.

BIO 300 is being developed as a medical countermeasure for ionizing radiation resulting from a nuclear or radiological attack, act of terrorism or accident. The initial application of BIO 300 is intended for military and civilian protection from events involving a nuclear device or weapon. However, the Company said today it also will focus on applications in medical diagnostics—particularly in the area of CT scans which have been linked recently to excessive levels of ionizing radiation.

“We are pleased that BIO 300 has reached this critical milestone,” said Ronald Zenk, President and CEO of Humanetics Corporation. “There is an urgent need for a safe and practical countermeasure to protect against the devastating effects of both lethal and non-lethal doses of ionizing radiation. We are also extremely concerned about patient exposure to high levels of ionizing radiation in common diagnostic CT scans. We anticipate that BIO 300 may become a standard of care for patients receiving CT scans,” he added.

Currently, there are 62 million CT scans conducted annually in the United States. Recent studies have found that patients may receive far more radiation from many common diagnostic CT procedures than previously believed. According to a recent report in USA Today, these scans may cause 29,000 new cancers a year as well as 14,500 deaths.

Department of Defense Support

BIO 300 has been developed in collaboration with the U.S. Department of Defense, primarily in response to the U.S. military and federal government’s urgent desire to identify and procure medical radiation countermeasures for Acute Radiation Syndrome (ARS), 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. ARS affects multiple organ systems with profound effects on the rapidly dividing cells of the bone marrow and intestinal tract with further later-stage effects to the lungs and other vital organs. The chance of survival for people with ARS decreases with increasing radiation exposure.

The Company is now expanding its BIO 300 program to include an array of disease states collectively known as the Delayed Effects of Acute Radiation Exposure. While not immediately lethal, these delayed effects can lead to pulmonary injury such as pneumonitis and pulmonary fibrosis months after exposure, often with a lethal outcome.

The primary objective in the development of BIO 300 is to provide a treatment for members of the military, first responders and the civilian population who may be the targets of a radiological or nuclear event. The urgency is underscored by the fact that there are no FDA-approved drugs to prevent or treat radiation injury.

Most of Humanetics’ research on BIO 300 has been supported by $7.75 million in appropriations funding from the U.S. Department of Defense. Since 2003, Humanetics has been working with researchers at AFRRI to develop BIO 300 as a safe and effective medical radiation countermeasure. A primary focus of their work is the development of effective compounds that can be self-administered by military and civilian populations in the event of radiation exposure. Humanetics is now expanding that technology to include use as a medical prophylactic for CT scans or cancer therapy. AFRRI, located in Bethesda, Maryland, is recognized as the nation’s premier center for radiation injury countermeasure research.

In 2007, BIO 300 was granted Orphan Drug Designation by the FDA. The U.S. Orphan Drug Act provides significant support, financial and marketing incentives and tax credits to companies that develop safe and effective therapies to treat rare diseases and conditions. To date, BIO 300 is the only drug granted this status as a medical countermeasure for the prevention of ARS.

BIO 300 is currently in Phase II clinical trials after showing strong evidence of safety in a Phase I human study.