April 27, 2018
HHS partners to develop new treatment for seizures caused by nerve agents
A new treatment for seizures that cannot be stopped with current medicines will be developed under an agreement between the U.S. Department of Health and Human Services (HHS)’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Proniras Corporation of Seattle, Washington. Uncontrollable seizures are a devastating result of exposure to nerve agents and can be deadly or lead to permanent brain damage.
“Nerve agents are the most toxic and rapidly acting of the known chemical warfare agents,” explained Rick Bright, Ph.D., director of the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR. “Although the Strategic National Stockpile includes anti-seizure medications, those medications may not be completely effective in stopping all seizures. To save more lives and improve long-term health for survivors, a second-line anti-seizure medication is needed.”
Under the 9-month, approximately $3 million agreement announced today, Proniras will develop Tezampanel as a treatment for seizures that have not been stopped by benzodiazepines, a class of drugs that includes the stockpiled medication diazepam (better known as valium). The contract can be extended up to a total of approximately $89.5 million over five years.
In clinical trials Tezampanel, which works by a different mechanism than diazepam, was shown to be safe. Recent studies also have shown Tezampanel to be an effective seizure treatment in rats with soman nerve agent poisoning, even when the drug was given after a significant delay. Soman is an extremely toxic man-made chemical warfare agent, originally developed as an insecticide in Germany in 1944.
Under the BARDA contract, Proniras will conduct studies to evaluate whether Tezampanel also stops seizures in rats even after benzodiazepine treatment has failed to do so. These studies may lead Proniras to apply for FDA approval of Tezampanel to treat seizures that do not respond to benzodiazepines, including seizures resulting from nerve agent exposure. Proniras also will explore other potential commercial uses for the drug.
Development of this new drug is part of ASPR’s efforts to develop medical products, procedures, and capabilities to protect health and save lives in terrorist attacks, including those using nerve agents. Nerve agents were used in an attack in the Tokyo subway in 1995 and in the Syrian civil war.
BARDA’s preparedness efforts include development of eight novel and repurposed therapeutics and PRISM, the first evidence-based decontamination procedures for use after 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 casualty situation and safe and effective for all segments of the population. Proposals are accepted through the Broad Agency Announcement BARDA- BAA-18-100-SOL-00003 at the Federal Business Opportunities website, www.fbo.gov.
The project announced today 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.
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies.