MINNEAPOLIS--(BUSINESS WIRE)--Humanetics Corporation (Humanetics) announced the publication of two noteworthy manuscripts detailing the development of BIO 300 as a radioprotective agent against acute radiation syndrome (ARS). These studies, published in peer-reviewed journals, highlight the radioprotective mechanisms of BIO 300, which is suitable for use by multiple routes of administration. The findings have implications for the development of BIO 300 as a radiation medical countermeasure (MCM) under the U.S. Food and Drug Administration's (FDA) Animal Rule.
The first manuscript, published in the journal Military Medicine, shares exciting findings from a pilot study testing BIO 300 as a protective measure against total body irradiation. In this study, researchers administered BIO 300 prior to exposure to radiation. The results showed that BIO 300 mediated improved survival, led to fewer fevers, maintenance of body weight, and quicker recovery of red blood cell counts. Additionally, tissue analysis revealed that the BIO 300 group suffered less damage from radiation, highlighting its potential as a protective agent.
The second manuscript, published in the International Journal of Molecular Sciences, explores the development of biomarkers for human dose translation of BIO 300 under the FDA's Animal Rule. Researchers studied blood samples from mice treated with BIO 300 and found important differences in gene activity with or without radiation exposure. Pathway analysis revealed that BIO 300 modulated key inflammatory and immune response pathways, identifying potential biomarkers for future human dosing strategies.
Dr. Michael Kaytor, Vice President of Research and Development at Humanetics, stated, “These publications mark a significant milestone in our commitment to advancing BIO 300 as an MCM. Our research highlights the potential of BIO 300, and we are dedicated to transforming our findings into effective solutions that can safeguard lives in radiation exposure environments.”
Humanetics is focused on pioneering medical solutions that address critical health challenges in individuals exposed to radiation. Radiation exposure can lead to ARS, which consists of numerous serious and life-threatening injuries. There are no FDA-approved drugs that can prophylactically prevent individuals exposed to radiation from developing ARS. Humanetics is developing BIO 300 as an MCM for use by the military, first responders, and in civilian populations that have been exposed, or may become exposed, to radiation to prevent ARS.
BIO 300 is also in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics 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).
About Humanetics Corporation
Humanetics Corporation is a clinical-stage pharmaceutical company engaged in the accelerated discovery, development, and commercialization of proprietary drugs in markets with urgent and unmet needs with a focus on radiation modulators for oncology and medical countermeasures. For more information, visit www.humaneticscorp.com.
