Humanetics Awarded Contract with National Cancer Institute

<0> Humanetics Corporation to Study and Develop a New Drug Candidate for Adjunctive Treatment of Non-Small Cell Lung Cancer </0>

<0> Humanetics Awarded Contract with National Cancer Institute </0>

<0> Humanetics CorporationEllen Hunter Gans, 612-708-7950 </0>

On September 17, Humanetics Corporation (Humanetics) was awarded a Small Business Innovation Research (SBIR) Fast Track Contract from the National Cancer Institute (NCI) to work with Henry Ford Hospital in Detroit to study and develop BIO 300 as a radiation modulator for use during radiotherapy of lung cancer.

The SBIR Fast Track award includes two phases. The Phase I award is for nine months, totaling $197,224 and includes preclinical proof of concept experiments. Phase II, if approved by NCI, will advance the drug into a human efficacy trial in lung cancer patients. The Phase II award is $1,499,181. The preclinical and clinical trials will be conducted at Henry Ford Hospital. Benjamin Movsas, M.D., chair of Radiation Oncology at Henry Ford, says, “This research is timely and could have potential implications for patients with lung cancer.”

The goal of the research is to demonstrate the ability of BIO 300 to improve outcomes in lung cancer patients who receive traditional radiation treatment. BIO 300 will be evaluated for its ability to sensitize lung cancer cells, making radiation more effective at reducing tumor size, while also protecting normal tissues from the negative side effects of radiation.

No drug currently exists with these characteristics, and there is an urgent and unmet need for improved treatment options. More than 300,000 individuals in the United States are being treated for non-small cell lung cancers. Lung cancer is the most common cause of cancer-related deaths in the United States, and non-small cell lung cancer comprises approximately 85% of lung cancer cases.

BIO 300 has already undergone substantial research related to its role as a medical radiation countermeasure. Over the past five years, Humanetics has received $8 million dollars in funding from the U.S. Department of Defense (DoD) to develop BIO 300 as a new medical radiation countermeasure (MRC) for lethal exposure to radiation, also known as Acute Radiation Syndrome (ARS).

In May of 2011, Humanetics was awarded a $3.5 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop BIO 300 as an MRC for the post-irradiation prevention of pneumonitis and pulmonary fibrosis, an indication that aligns with the research that will be undertaken under the newly awarded NCI contract.

Ronald Zenk, President and CEO of Humanetics, says, “We are delighted that the US Government continues to recognize and explore the potential uses of BIO 300 – from the DoD to BARDA and now to NCI.” The project to be undertaken under this new contract will be fully funded using Federal funds from the National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN261201200078C.

Humanetics is a privately held specialty pharmaceutical company headquartered in Minneapolis, Minnesota. Humanetics has proprietary compounds in clinical and pre-clinical stages in the areas of medical radiation countermeasures, Alzheimer’s disease, PTSD and obesity. For more information, visit: .

The National Cancer Institute (NCI) is part of the National Institutes of Health (NIH), which is one of 11 agencies that compose the Department of Health and Human Services (HHS). The NCI, established under the National Cancer Institute Act of 1937, is the Federal Government's principal agency for cancer research and training.

Henry Ford Hospital, the flagship facility for Henry Ford Health System, is an 802-bed tertiary care hospital, education and research complex. The hospital is staffed by the Henry Ford Medical Group, one of the nation's largest and oldest group practices with 1,200 physicians in more than 40 specialties. The hospital, which opened in 1915, is a Level 1 trauma center, recognized for clinical excellence and innovations in the fields of cardiology, cardiovascular surgery, neurology and neurosurgery, sports medicine, organ transplants, and treatment for prostate, breast and lung cancers. The hospital annually trains more than 700 medical students, 500 residents and 125 fellows in 46 accredited programs. In 2011, the hospital opened the Innovation Institute, a project aimed at shaping the future of medicine. The hospital and campus are led by CEO John Popovich Jr., M.D. To learn more, visit HenryFord.com