Department of Defense Medical Identification & Treatment Systems (U.S.): CSC Develops Treatment to Protect Armed Forces from Nerve Agent Attacks
The Client
U.S. Department of Defense Medical Identification & Treatment Systems (MITS)
The Challenge
Chemical nerve agents including sarin, soman and VX are a real threat to military personnel. To better protect U.S. armed forces, the Department of Defense enlisted CSC’s DVC to develop and test a treatment to counteract the effects of chemical nerve agent attacks.
The Solution
DVC teamed with Baxter Healthcare Corporation to take proof-of-concept studies conducted by the Department of Defense forward into advanced development. DVC will handle project management and phase 1 clinical testing, and Baxter will perform manufacturing, regulatory interactions with the U.S. Food and Drug Administration (FDA) and preclinical testing.
The Results
After process development and initial production, BioScavenger must go through pre-clinical testing to show that the treatment is safe before it can be tested in humans. With only two years to complete a phase 1 clinical trial, the CSC team faces an aggressive timeline to deliver results. The BioScavenger team is making rapid progress, and is working to ensure delivery of a safe therapeutic candidate.
Read more about CSC’s work on treatments to counteract the effects of certain chemical nerve agents.
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DVC LLC, a CSC company, has developed products to protect against biowarfare agents since 1997. DVC is now breaking new ground by developing a treatment for chemical agent attacks. The treatment, nicknamed "BioScavenger," uses human plasma-derived butyrylcholinesterase to counteract the effects of chemical nerve agents such as sarin, soman, and VX.
DVC, a biopharmaceutical company dedicated to the development and licensure of safe and efficacious biodefense vaccines for the U.S. Department of Defense and civilian populations, has comprehensive experience in the advanced development of biodefense biologics, including live attenuated vaccines, recombinant vaccines, therapeutics, therapeutic polyclonal antibodies and alternative vaccine delivery systems.
Based in Frederick, Maryland, DVC is organized under CSC’s Enforcement, Security and Intelligence division and has a team of 10 employees that works on this 2-year, $19.6 million contract.
MITS, Baxter and CSC: Teaming to Develop a Treatment
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The client for this contract is the Department of Defense (DOD) Medical Identification and Treatment Systems (MITS) Joint Product Management Office. MITS manages the development and fielding of products used to diagnose and treat chemical and biological agent warfare exposure in U.S. military personnel.
MITS products range from specific hardware devices that will enable medical personnel to diagnose specific biological warfare agent exposure, to drugs that will prevent or mitigate the actions of chemical or biological agents.
DVC teamed with Baxter Healthcare Corporation to take proof-of-concept studies conducted by the DOD forward into advanced development. The DVC team will handle project management and the Phase 1 clinical trial. Baxter will perform manufacturing, regulatory interactions with the U.S. Food and Drug Administration (FDA), and pre-clinical testing.
"Our project management experience and Baxter's previous work with butyrylcholinesterase played a large role in helping us to win this contract," said Dr. Barbara Solow, director of business development.
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Beating Chemical Agent Attacks
The treatment, called BioScavenger, works in a different manner than a vaccine. Vaccines trigger an immune response, while a chemical agent treatment must inhibit the chemical.
"The treatment is called BioScavenger because it is based on butyrylcholinesterase, which is an enzyme derived from human plasma, and because it floats through the bloodstream where it binds and inactivates the chemical agents, " said Dr. Solow. "Nerve agents work by binding to enzymes that are involved in transmission of messages between nerves, preventing those messages from being communicated correctly. When this happens, your nerves do not work and your critical functions, such as breathing, stop. Butyrylcholinesterase binds to the chemical agents and prevents them from counteracting the proper transmission of signals between nerves."
Providing a Treatment for the Department of Defense
While BioScavenger works differently from the vaccines that DVC develops, the FDA approval process is similar. After process development and initial production, BioScavenger must go through pre-clinical testing to show that the treatment is safe before it can be tested in humans. After pre-clinical testing, an Investigational New Drug application will be filed with the FDA, and the treatment will begin clinical trials.
The DVC team is on a very aggressive schedule to develop and test BioScavenger. A phase 1 clinical trial is scheduled to be completed by the end of the two-year contract. Following the phase 1 clinical trial, DVC hopes to obtain additional funding to advance the product to licensure. Once the treatment has gained licensure, it will be used to protect military personnel who may be exposed to nerve agents or who have suffered an attack.
In addition to DOD use, once approved by the FDA, BioScavenger could potentially be used as treatment in the civilian population in the case of a chemical terrorist attack or to help protect first responders.
For more information, visit www.csc.com/dvc.
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