Pharma Focus Europe

Humanetics Receives FDA Clearance to Begin Studies in Second Oncology Indication

Thursday, October 06, 2022

Humanetics Corporation (Humanetics) announced today that it has received FDA clearance of its Investigational New Drug (IND) application for BIO 300 to mitigate erectile dysfunction in men undergoing radiation treatment for prostate cancer. This is the second IND for BIO 300 in oncology patients, and the fourth IND overall for the Company.

Aside from non-melanoma skin cancer, prostate cancer is the most common cancer in men and is often treated with radiation. Unfortunately, greater than 50 percent of men treated with radiation will experience radiation-induced erectile dysfunction (RiED). RiED greatly affects patient quality of life and, in most cases, is permanent and unresponsive to drugs such as Viagra® and Cialis®. The chance of developing RiED, especially in younger men, can alter treatment decisions and can push patients toward less effective treatment options. Currently, there are no treatments available to mitigate RiED in these patients.

BIO 300 is an oral drug that is self-administered at home by the patient prior to their radiation treatments. It has shown potential to minimize radiation damage in normal tissues without impacting the effectiveness of the radiation therapy against the tumor. Previously, Humanetics published nonclinical studies demonstrating that BIO 300 can prevent RiED. Additionally, nonclinical research with BIO 300 has shown that it may help improve the effectiveness of radiation against multiple types of tumors. BIO 300 was the recent subject of an early-stage trial in non-small cell lung cancer patients undergoing chemoradiotherapy and was found to be safe, with results pointing to positive clinical outcomes.

Humanetics licensed BIO 300 from the United States Department of Defense (DOD), where it was discovered as a potent radioprotectant for warfighters on the battlefield. Humanetics is continuing the development of BIO 300 on behalf of DOD for use by military personnel, first responders, and civilian populations who may be threatened with radiation exposure. Its use in cancer patients is highly aligned with its military use, as it serves in both cases to protect normal tissues from radiation damage. The drug is also being evaluated in a phase 2 trial of long COVID patients to determine if it can mitigate pulmonary damage.

“Continuing to expand the use of BIO 300 with cancer radiation therapy is one of our major goals,” said Ronald J. Zenk, President and CEO of Humanetics. “We believe that BIO 300 may improve treatment outcomes across several types of solid tumors.”

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