Efficacy of BIO 300 was compared to PEGfilgrastim (Neulasta®).

MINNEAPOLIS, MN — A recently published paper in Radiation Research, the official journal of the Radiation Research Society, details the results from studies conducted with Humanetics Corporation’s (Humanetics) new radioprotective drug, BIO 300, finding that BIO 300 is uniquely effective at protecting against radiation-induced lung injury.

The studies, which were conducted by researchers at the Armed Forces Radiobiology Research Institute, a research laboratory within the Department of Defense, performed a comparative evaluation of the efficacy of BIO 300 to prevent delayed lung injury using both oral and intramuscular dosing prior to total-body irradiation. Specifically, these nonclinical studies compared the efficacy of BIO 300 to FDA-approved PEGfilgrastim (Neulasta®), and the combination treatment of BIO 300 plus PEGfilgrastim.

PEGfilgrastim is currently approved only to treat acute radiation injury, and is only efficacious when administered by injection after radiation exposure. The researchers concluded that both BIO 300 formulations, as well as the combination of BIO 300 with PEGfilgrastim, demonstrated significant efficacy in preventing radiation-induced lung inflammation and fibrosis, whereas PEGfilgrastim administered alone had minimal impact on such delayed lung injuries. These studies highlight the considerable advantages of BIO 300, which can prophylactically prevent both acute and delayed radiation injuries.

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 prophylactically 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.

"We're tremendously encouraged by what we see as very positive, promising results for BIO 300 based on these important new studies,” said Ronald J. Zenk, CEO at Humanetics. “Given the current geopolitical climate, the need for prophylactic prevention of acute and delayed radiation injury is more urgent than ever."

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).

The views expressed herein are those of Humanetics Corporation and may not reflect the official policy or position of the U.S. Department of the Army, U.S. Department of Defense, Armed Forces Radiobiology Research Institute, or the U.S. Government.