The first potential antidote to treat the life-threatening effects of chlorine inhalation, a potential terrorism threat, will advance in development under a contract between the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Radikal Therapeutics, Inc. of Beverly, Massachusetts.
Chlorine gas is a widely available industrial chemical with catastrophic consequences in industrial accidents. Derailment of a train carrying chlorine in Graniteville, South Carolina, in 2005 led to nine deaths and hundreds of injuries. In addition, chlorine gas has been used as a weapon, for the first time in World War I and repeatedly in the recent Syrian civil war.
Today’s two-year $15.9 million contract is part of efforts by ASPR’s Biomedical Advanced Research and Development Authority (BARDA) to develop medical products and procedures to protect health and save lives in a terrorist attack, including those using toxic industrial chemicals like chlorine. The contract could be extended up to a total of $84.9 million over seven years.
“The United States faces a wide variety of threats to health security – from new infectious diseases like Zika to bioterrorism and accidents involving deadly gases like chlorine,” said BARDA Acting Director Dr. Richard Hatchett. “Not being prepared for any of them could cost lives; we must be ready to protect health against the multitude of threats our country faces.”
Radikal’s development of the antidote known as R-107 began with more than $2.6 million in funding over four years from the National Institutes of Health CounterACT program. Under today’s agreement with ASPR, the company will develop a more efficient way to produce large quantities of R-107 and conduct non-clinical studies to establish the drug’s safety and effectiveness as a lifesaving treatment for acute lung injury resulting from inhaled chlorine.
If non-clinical studies are successful, R-107 could begin clinical studies to establish safety and efficacy in humans. This development work would not expose people to dangerous levels of chlorine gas and would support Radikal’s submission of an application to the U.S. Food and Drug Administration (FDA) for approval of R-107 as an antidote for chlorine exposure.
ASPR’s BARDA continues to seek proposals for the development of effective medical countermeasures and interventions for chemical threats, including new products and new indications for products already in clinical use. The products must be easy to use in a mass casualty situation and safe and effective for all segments of the population. Proposals are accepted through the Broad Agency Announcement BARDA-CBRN- BAA-16-100-SOL-00001 at the Federal Business Opportunities website, www.fbo.gov.
This new project is part of an integrated portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear (CBRN) agents, pandemic influenza, and emerging infectious diseases.