BIO 300 is intended as a broadly utilized radioprotectant therapy to mitigate the cellular and biological consequences of radiation exposure. In our Phase I/II clinical trial, 7 patients have taken BIO 300 daily for 8 weeks, while undergoing daily fractionated radiation doses of 2Gy, for a total cumulative dose of 60 Gy. Thus, we suggest that BIO 300 could be taken daily for the entire duration of a mission. Yet as chronic dosing for multiple astronauts may become weight limiting (with respect to amount of drug required to be put on a rocket) we also have data suggesting that BIO 300 can be taken acutely (in 1-3 doses) to mitigate larger radiation events, such as Solar Particle Events. As these events can constitute a large percentage of the total radiation dose over the mission, BIO 300 could be administered intermittently to mitigate these larger exposure radiological events.
Humanetics is aggressively pursuing multiple modes of radioprotection interests for Earth applications. Our interest in the protection of normal tissue during clinical radiotherapy has manifested itself into a clinical trial in lung cancer patients receiving fractionated radiotherapy. Secondly, in preclinical studies, BIO 300 has been shown to mitigate radiation-induced erectile dysfunction following prostate radiation. Hence, a clinical trial in prostate cancer patients is planned to evaluate BIO 300?s ability to prevent radiation-induced erectile dysfunction. Finally, BIO 300 is being developed as a low-dose radioprotectant. For example, there is significant evidence that medical imaging techniques (e.g. CT Scans) which rely on ionizing radiation can pose significant risks, especially in younger patients and those subjected to multiple scans. For example, some traumatic brain injury patients will receive 20 to 50 brain CTs in a single year. Other applications of BIO 300 development include Department of Defense interests in countermeasures for radiation exposure.