FORT DETRICK, Md. – A new injectable antidote for cyanide exposure invented at the U.S. Army Medical Research Institute of Chemical Defense has been exclusively licensed to a pharmaceutical company for further development, bringing it one step closer to eventually providing Service Members with a rapidly effective countermeasure in the event of a cyanide attack. This new capability addresses a critical DOD need for a deployable cyanide countermeasure for use during mass casualty events.
Though cyanide is used in a wide variety of manufacturing processes, it is also highly toxic and is considered to be a potential chemical warfare agent. A lethal dose can kill within seconds; non-lethal doses can leave survivors with a range of permanent physical and neurological effects. USAMRICD’s next-generation countermeasure promises to improve patient survivability by offering a longer shelf life and greater portability than the intravenous cyanide antidotes currently in use. Furthermore, the new antidote requires less time to prepare and administer – important considerations for Warfighters deployed in far forward areas facing contested logistics and degraded MEDEVAC capability.
“This would be the first non-intravenous cyanide countermeasure approved by the U.S. Food and Drug Administration, which is very exciting,” says Dr. Gary A. Rockwood, a research biologist in the institute’s Medical Toxicology Division who pioneered the development of the antidote. “We are envisioning the antidote being delivered by autoinjector, similar to an EpiPen, that could quickly and easily be administered into a muscle mass by a medic or even a battle buddy.”
Rockwood has been researching cyanide countermeasures for most of his career at USAMRICD, and co-authored a seminal scientific paper on the efficacy of dimethyl trisulfide as a cyanide antidote. DMTS – a naturally occurring volatile compound found in garlic, cabbage, and onions, among other foods – is the active ingredient in the new countermeasure.
After multiple studies demonstrated that intramuscular DMTS was more effective than similar doses of thiosulfate, the chemical used in one of the current intravenous cyanide countermeasures, Rockwood reached out to the Defense Health Agency Research and Development-Medical Research and Development Command’s Office of Medical Technology Transfer to identify a pharmaceutical company with the requisite experience and capability to develop the antidote for commercial production – a necessary step for making it available to the DOD. The tech transfer office works with inventors of new biomedical products to help them navigate the complex process of obtaining funding to develop their products, collaborate with labs and medical facilities to test them, and license them to manufacturers from which the DOD purchases them for use by Warfighters.
“We talked with several companies and venture capitalists, and tried to leave no stone unturned,” says Dr. David Humphrey, a licensing officer at MTT who worked with Rockwood on the process. “It was very much a joint effort; Dr. Rockwood was looking as hard as I was because he firmly believes the product needs to get out there. I’ve been in technology transfer for 20 years, and this agreement probably had the most moving parts of any that I've ever done.”
Humphrey negotiated an exclusive license with Defender Pharmaceuticals, a St. Louis-based life sciences company. The agreement enables Defender to use the antidote’s patents and USAMRICD’s extensive body of experimental research to prepare a submission to the FDA seeking its approval to undertake clinical studies that are required before the antidote can be brought to market. Defender will work with DHA R&D-MRDC’s Office of Regulated Activities to prepare the FDA submission.
In addition to USAMRICD researchers, the team involved in developing the injectable cyanide countermeasure included researchers from several universities and research laboratories. The research resulted in over 20 papers published in scientific journals. Rockwood says the innovative research and development process he and his colleagues followed could be a model for bringing future similar countermeasures to market.
“There definitely were challenges along the way that we've learned a lot from,” says Rockwood. “But I think that the approach we took provides a potential option for future research. It may take some creativity, may take some patience, but there are alternatives to the typical pathways to getting a product through the regulatory process and into the hands of people who need them.”
DISCLAIMER: References to non-federal entities do not constitute or imply U.S. government, Department of Defense, or U.S. Army endorsement of any company, product, or organization.
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