January 14, 2014

Humanetics Corporation granted approval by the National Cancer Institute to proceed with cancer treatment study

Clinical trial will evaluate the ability of Humanetics' proprietary compound BIO 300 to protect normal tissues from radiation and chemotherapy during non-small cell lung cancer treatment

MINNEAPOLIS, MN — Following successful completion of Phase I of a Fast Track Contract, Minneapolis-based Humanetics Corporation (Humanetics), together with its research collaborators at Henry Ford Hospital in Detroit, has been granted approval from the National Cancer Institute (NCI) to move to Phase II of the contract. This phase will include an exploratory clinical trial to evaluate the ability of Humanetics' proprietary compound, BIO 300, to lessen the normal tissue side effects from chemotherapy and radiation associated with lung cancer treatment.

The trial will be led by Dr. Benjamin Movsas, Chairman of the Department of Radiation Oncology at Henry Ford Hospital. Dr. Movsas and his team are particularly interested in preserving the quality of life among non-small cell lung cancer patients undergoing chemotherapy and radiation treatment. A secondary endpoint for the clinical trial will evaluate local control of tumor response.

“This is an important clinical trial to explore a novel strategy to protect normal lung tissue and thereby enhance the quality of life for lung cancer patients receiving chemoradiation therapy,” says Dr. Movsas.

Dr. John Popovich Jr., President and CEO of Henry Ford Hospital adds: “We are very excited to be able to soon offer this very timely trial at Henry Ford Hospital.”

Humanetics will file an Investigational New Drug Application prior to starting the trial. There are currently no approved drugs to protect normal lung tissue from the damage caused by radiation and chemotherapy treatments.

Lung cancer is the most common cause of cancer-related deaths in the United States. This year, an estimated 228,000 new cases of lung cancer will be diagnosed, and lung cancer will be responsible for approximately 159,000 deaths. Non-small cell lung cancer is the most common type of lung cancer, comprising approximately 85% of all cases. In spite of ever-increasing attention, survival rates for lung cancer have not significantly improved over the past 40 years.

"We're looking forward to taking this significant next step toward improving outcomes for this devastating disease," said Ronald J. Zenk, CEO of Humanetics Corporation.

The clinical trial is expected to begin in mid-2014.

About Humanetics Corporation

Humanetics Corporation is a clinical-stage specialty pharmaceutical company engaged in the discovery, development and commercialization of proprietary drugs, medical foods and consumer products in markets with urgent and unmet needs. For more information, visit www.humaneticscorp.com.

About Henry Ford Hospital

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. In 2011, the hospital opened the Innovation Institute, a project aimed at shaping the future of medicine. The hospital and campus is led by President and CEO John Popovich Jr., M.D. To learn more, visit HenryFord.com.