Fast Track designation allows for expedited review of new drugs by FDA

Humanetics Corporation (Humanetics) announced today that BIO 300, a drug under development to increase survival in persons exposed to high levels of radiation, has been granted Fast Track status by the U.S. Food and Drug Administration (FDA).

The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designation allows a company to file the components of a New Drug Application (NDA) on a rolling basis and permits the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs for Fast Track development programs are eligible for priority review, which may result in an abbreviated review time.

BIO 300 is under advanced development by Humanetics as a medical countermeasure to protect healthy human tissues and organs from harm caused by ionizing radiation. BIO 300 was initially discovered by researchers at the U.S. Department of Defense through their efforts to create radioprotective drugs for the military, and subsequently exclusively licensed to Humanetics. The drug is designed to be taken before radiation exposure and has shown an ability to protect the body’s bone marrow cells. It has applications for warfighters and emergency responders who need to operate in areas of potential or known radiation exposure, which may be caused by detonation of a nuclear weapon or a radiation dispersal device, also known as a dirty bomb.

“We are extremely pleased that BIO 300 has received Fast Track status for this indication,” said Ronald J. Zenk, President and CEO of Humanetics Corporation. “Radiation protection for warfighters and first responders is an unmet need and we look forward to working closely with FDA to bring this drug to market as quickly as possible.”

Due to its protective properties, BIO 300 is also being developed for use in cancer patients that receive radiation treatments to reduce tumors, and further studied in COVID-19 patients to prevent progressive lung injury. Humanetics recently completed a clinical trial of BIO 300 in lung cancer patients aimed at mitigating pulmonary injury related to their radiation treatments (ClinicalTrials.gov NCT02567799) and is currently enrolling a clinical trial of the drug in COVID-19 patients recently discharged from the hospital who are at risk of developing long-term pulmonary complications (ClinicalTrials.gov NCT04482595).

About Humanetics Corporation

Humanetics is a clinical-stage pharmaceutical company engaged in the discovery, development and commercialization of proprietary drugs to prevent severe tissue damage caused by exposure to radiation, viral infection and other inflammatory diseases. For more information, visit www.humaneticscorp.com.

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