BIO 300 improved survival equal to FDA-approved Neulasta® in a model of lethal Acute Radiation Syndrome.

MINNEAPOLIS, MN — A recently published paper in the International Journal of Radiation Biology details results from a series of studies conducted with Humanetics Corporation’s (Humanetics) new radioprotective drug, BIO 300. In collaboration with researchers at the Uniformed Services University of the Health Sciences, within the United States Department of Defense (DoD), Humanetics compared the efficacy of BIO 300 to that of Neulasta®, an FDA-approved drug manufactured by Amgen Corporation, which is being stockpiled for nuclear or radiological emergencies. This nonclinical research showed that giving BIO 300 prior to exposure to lethal levels of radiation improved survival equal to Neulasta®, which is given after exposure. This protective effect of BIO 300 is of special interest to DoD, as they search for prophylactic agents that would allow warfighters to safely enter and operate in areas of known or potential nuclear or radiological risk. A protective drug like BIO 300 would also be ideal for first responders to nuclear accidents, such as those in Chernobyl, Ukraine, and Fukushima, Japan.

Exposure to radiation can lead to acute radiation syndrome (ARS), which involves a multitude of injuries, including bone marrow failure. Neulasta® is one of the four FDA-approved medical countermeasures used to treat ARS. All four require subcutaneous administration within 24-48 hours after exposure, require special storage and handling, and may need to be administered by qualified medical personnel. Therefore, these drugs are not ideal for treatment in a chaotic and austere war or accident zone. Of particular interest to DoD is that BIO 300 is an oral drug that can be easily self-administered and requires no special storage or handling.

“We continue to collaborate with our colleagues at DoD on the development of BIO 300,” said Ronald Zenk, CEO of Humanetics. “Current world events speak to the need for drugs such as BIO 300 and we are working diligently to get this drug to a point where it can be available under an Emergency Use Authorization mechanism.”

BIO 300 is also in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics recently completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799).  In addition, a phase 2b trial is currently in progress evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).