Humanetics Granted FDA Clearance To Proceed With Cancer Treatment Study

Phase I/II clinical trial will evaluate safety and the ability of Humanetics' proprietary compound BIO 300 to protect normal tissues from chemoradiation during non-small cell lung cancer treatment

MINNEAPOLIS--(BUSINESS WIRE)--Minneapolis-based Humanetics Corporation (Humanetics) announced today that its Investigational New Drug application for the proprietary compound BIO 300 has cleared U.S. Food and Drug Administration (FDA) review. Humanetics, along with research partners at Henry Ford Hospital, will proceed with a phase I/II clinical trial to evaluate the safety of BIO 300 and its ability to lessen the damage to normal lung tissue resulting from chemoradiation lung cancer treatment.

“The clearance we’ve received from the FDA represents a critical step forward in our important research, and we look forward to continuing our efforts to improve outcomes for patients receiving chemoradiation treatment.”

Dr. Benjamin Movsas, Chairman of the Department of Radiation Oncology at Henry Ford Hospital, will lead the trial. Dr. Movsas and his team will assess safety, pharmacokinetics, and efficacy outcomes in an effort to protect healthy tissues during treatment of non-small cell lung cancer in patients receiving chemoradiation.

Dr. Movsas and his team are particularly interested in preserving quality of life for patients, and protecting healthy tissues is one way to do so. “An underlying approach of this clinical trial at Henry Ford Hospital is to study a novel agent with a goal to reduce the side effects from chemoradiation for patients with lung cancer, thereby enhancing the patients’ quality of life,” said Dr. Movsas.

Lung cancer is the most common cause of cancer-related deaths in the United States. This year, an estimated 221,000 new cases of lung cancer will be diagnosed, and lung cancer will be responsible for approximately 158,000 deaths. Non-small cell lung cancer is the most common type of lung cancer, comprising approximately 85% of all cases. There are currently no other drugs approved to protect normal lung tissue from the effects caused by chemoradiation treatment.

"Non-small cell lung cancer is a devastating disease, and the unintended damage to normal lung tissue resulting from radiation and chemotherapy treatments are often detrimental to quality of life,” said Ronald J. Zenk, CEO of Humanetics. “The clearance we’ve received from the FDA represents a critical step forward in our important research, and we look forward to continuing our efforts to improve outcomes for patients receiving chemoradiation treatment.”

Humanetics and Henry Ford Hospital expect to begin enrolling patients for the clinical trial this summer. This trial is partially funded under a Small Business Innovation Research (SBIR) Fast Track Contract from the National Cancer Institute.

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 877-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 CEO John Popovich Jr., M.D. To learn more, visit HenryFordHospital.com