Humanetics' lead focus is BIO 300 -- being developed as a radiation modulator for multiple indications, having been extensively studied as a potential cancer therapeutic and as a radioprotectant. BIO 300 was the subject of a research program conducted by the Armed Forces Radiobiology Research Institute where its radioprotective effects were confirmed. The active ingredient in BIO 300 is a small molecule with limited solubility and poor oral bioavailability, which prevents absorption of therapeutic doses without proper formulations. Humanetics has developed a patented, stable nano-particle formulation that greatly improves oral bioactivity (see Pharmacokinetic Data). BIO 300 having a variety of biological effects underlies to unique efficacy as a radiation modulator to include effects on cell cycle regulation, oxidative stress and inflammation. BIO 300's unique mechanism allows it to selectively protect normal tissues and to avoid protection of tumor cells. In Phase I/II clinical trial in patients undergoing radiochemotherapy for non-small cell lung cancer, BIO 300's unique mechanism allows it to selectively protect normal tissues and to avoid protection of tumor cells. Humanetics entered the field of radiation modulators in 2003, through a cooperative research program with the Armed Forces Radiobiology Research Institute (AFRRI). AFRRi's mission is the discovery and early development of drugs that can protect warfighters from the harmful effects of radiation. Humanetics began working with AFRRI to test an array of drug candidates using their highly developed capabilities. From this program, BIO 300 emerged as a lead candidate and the underlying technology was in-licensed from the DOD to Humanetics. In the ensuing years, the Company has progressed this program into clinical stage with a primary focus on improving the treatment outcomes for patients receiving radiation treatment of solid tumors. Humanetics has two open INDs for BIO 300 and is currently in a Phase 1b/2a clinical trial. Having strong partnerships with private and public research institutions having unique capabilities to test radiation modulators, in additon to SBIR awards, Humanetics has received over $26 million in non-dilutive funding from various parts of and from the Biomedical Advanced Research and Development Authority (BARDA), The National Space Biomedical Research Institute (NSBRI) and the Department of Defense (DoD).
