Studies compared multiple routes of administration with and without radiation exposure


MINNEAPOLIS, MN — A recently published paper in Radiation Research, the official journal of the Radiation Research Society, details the results from a series of pharmacokinetics (PK) studies conducted with Humanetics Corporation’s (Humanetics) new radioprotective drug, BIO 300. The studies, which were conducted by researchers at the University of Maryland Schools of Medicine and Pharmacy (UMB), compared the PK of BIO 300 using oral, subcutaneous, and intramuscular dosing. These nonclinical studies also examined the effect of radiation exposure on the PK of BIO 300. The researchers concluded that the effect of irradiation on the PK of BIO 300 is minimal, an important finding for use of the drug during radiation emergencies or during cancer radiotherapy treatments.

Exposure to radiation can lead to acute radiation syndrome (ARS), which consists of numerous serious and life-threatening injuries. Survivors of ARS are at risk of developing delayed effects of acute radiation exposure (DEARE), which include a multitude of chronic injuries, notably to the lungs. There are currently no FDA-approved drugs that prevent ARS or DEARE. Humanetics is developing BIO 300 as a medical countermeasure (MCM) for use by the military, first responders, and in civilian populations that have been exposed, or may become exposed, to radiation to prevent or mitigate both ARS and DEARE.

“Our ongoing collaboration with colleagues at UMB has been instrumental in the development of BIO 300 for use as a MCM,” said Ronald Zenk, CEO of Humanetics. “Current events in Ukraine and global threats of nuclear incidents point to the urgent need for drugs like BIO 300.”

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).