Medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, a naturally occurring emerging disease, or a natural disaster.
Before a medical product can be approved by FDA, it must be demonstrated as efficacious. In the case of developing MCMs for radiological and nuclear threats, exposing human subjects to radiation is not be ethical or feasible. As such, FDA will grant approval based on well-controlled nonclinical studies. There is also a requirement to demonstrate the drug’s safety in humans.
Medical Countermeasures are purchased and stockpiled by the Department of Health and Human Services, the Department of Defense and various foreign governments and militaries.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies.
Active Development Programs
Acute Radiation Syndrome (ARS)
The efficacy of BIO 300 as a MCM was discovered and initially developed by the Department of Defense (DoD) and the National Institutes of Health. This use of BIO 300 is protected by two issued US Patents (#7,655,694 and #8,349,888), and Humanetics has the exclusive worldwide rights to this intellectual property. Humanetics has successfully opened a new Investigational New Drug application (IND 74460) with FDA to develop BIO 300 for ARS. FDA has granted BIO 300 Fast Track Status, which allows for a more rapid regulatory process toward approval. In addition, BIO 300 has been granted an Orphan Drug Designation for the Prevention of Acute Radiation Syndrome.
We have found that BIO 300 given prophylactically dramatically increases survival in animal models exposed to an acute dose of lethal radiation. Humanetics has completed multi-species nonclinical studies and collected human safety data in support of the development of BIO 300 as MCM for ARS. A Phase 1 safety study in male and female healthy human volunteers has provided evidence that BIO 300, given orally, can be used safely at the intended dosage and achieves levels in the blood to activate its therapeutic target.
We envision that BIO 300 will be self-administered by war fighters going into harm's way. It also holds promise as a drug for use by first responders and civilians who face the threat of radiation exposure from a nuclear accident or terrorist threat.
Delayed Effects of Acute Radiation Exposure (DEARE)
Development of radiation-induced pneumonitis and fibrosis in the lung is a delayed effect of acute radiation exposure. Both types of lung injury also are observed today in patients who have undergone thoracic irradiation for the treatment of lung, breast, or hematologic malignancies. These lung maladies have also been observed in individuals accidentally exposed to radiation resulting from an environmental radiological event.
Radiation-induced pneumonitis in humans usually becomes apparent approximately two to four months after irradiation exposure, while radiation-induced fibrosis develops six months or more after exposure. These lung insults result from a combination of direct cytotoxicity and the triggering of radiation-induced cellular signal transduction pathways, reducing the functional capacity of the lung and can be fatal.
Humanetics is developing BIO 300 as a MCM to treat the effects of DEARE, focusing on radiation-induced pneumonitis and pulmonary fibrosis. We have recently completed a two-year BARDA contract for the continued development of BIO 300 as a pharmacological medical countermeasure (MCM) to ionizing radiation. Results in this program have been positive and indicate that further development efforts should continue.