Public Health Emergency - Leading a Nation Prepared
A potential antidote to treat the life-threatening effects of inhaled chlorine gas, a national security threat, will receive drug development support under a contract between the Biomedical Advanced Research and Development Authority (BARDA), a component of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and GSK, one of the world’s leading research-based pharmaceutical and healthcare companies.
Exposure to high levels of chlorine gas can cause death from suffocation within 30 minutes. Currently, there is no specific antidote for lung injuries caused by chlorine exposure, and treatment has been limited to supportive care.
“Chlorine inhalation is one of the many national security threats the United States faces, and to save lives when every minute counts doctors must have treatment options at their fingertips before a crisis occurs,” said BARDA Director Rick Bright, Ph.D. “We’re taking an innovative approach with the goal of developing a treatment that has the potential to become readily available to counteract the horrific health effects of exposure to high concentrations of chlorine gas that could be used in terrorism or result from an industrial accident.”
This 2-year, $17 million cost-sharing contract is the first BARDA has funded to develop a treatment for inhaled chlorine injuries that also would have common uses in medicine. GSK is developing a class of drugs known as TRPV4 channel blockers to treat respiratory diseases.
If development of a drug in this class is successful and receives U.S. Food and Drug Administration approval, the drug could become a first-in-class drug for the targeted respiratory conditions and the first approved treatment for lung injury from chlorine.
In addition, if marketed for respiratory diseases, the drug could be readily available in hospitals as treatment for chlorine inhalation in an emergency. With this approach, the treatment may reach victims within minutes; with the traditional approach of stockpiling, drugs must be shipped which can take up to a day.
Today’s contract is part of BARDA’s efforts to support the development of medical products and procedures to protect health and save lives in terrorist attacks, including those using toxic industrial chemicals like chlorine.
Chlorine gas has been used as a weapon of war and terrorism for almost 100 years, the first time in World War I and repeatedly over the past few years in Syria. Chlorine gas is also a widely available industrial chemical and has 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.
Under the agreement, GSK will complete non-clinical studies that do not involve people to demonstrate efficacy against chlorine. In support of developing a widely available marketed product, the company will conduct clinical studies to demonstrate the safety and efficacy of the drug as a treatment for respiratory diseases.
In addition to this new project with GSK, BARDA is working with Radikal Therapeutics, Inc. of Beverly, Massachusetts, on a drug to address different lung-related injuries caused by chlorine inhalation. Development of that drug, R-107, began with funding from the National Institutes of Health CounterACT program and transitioned to BARDA for later stages of development. The drug is being developed solely as a chlorine injury treatment.
These treatments are among the post-exposure treatments and non-pharmaceutical interventions BARDA and its private partners are developing to counter the health effects of chemical exposure. Products include novel and repurposed therapeutics, and decontamination for treatment of exposure to any of four classes of chemical agents.
BARDA continues to seek proposals for the development of effective products to treat injuries caused by chemical agents, including new products and new indications for products already in clinical use. The products must be easy to use in a mass emergency situation and safe and effective for all segments of the population. Proposals are accepted through a Broad Agency Announcement available on the Federal Business Opportunities website, www.fbo.gov.
The contract with GSK is part of BARDA’s integrated portfolio for 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 agents, pandemic influenza, and emerging infectious diseases.
ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security. HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
To learn more about preparedness, response and recovery from the health impacts of disasters, visit the HHS public health and medical emergency website, www.phe.gov. For more information about advanced research and development of medical countermeasures, visit www.medicalcountermeasures.gov.
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