After eight years of focusing on vaccines to counter biowarfare agents, DVC LLC has won a $19.6 million government contract to develop its first therapeutic to treat exposure to a different terrorist threat - chemical warfare.
The Department of Defense Medical Identification and Treatment Systems (MITS) Joint Product Management Office awarded the two-year contract to Frederick, Md.-based DVC to develop plasma-derived human butyrylcholinesterase. The enzyme is found in human blood plasma and has inhibited organophosphorous chemical nerve agents such as sarin, soman and VX.
"This has already been tested by various research laboratories," said Barbara Solow, DVC's director of business development. "It is shown to be effective in nonclinical studies in inhibiting the toxic effects of nerve gas after exposure."
DVC will work with manufacturer Baxter Healthcare Corp., of Deerfield, Ill., to develop a candidate to be used in a Phase I trial. Baxter has experience using its plasma and cell culture technology platforms to provide therapeutics for biodefense initiatives. The candidate for development has been nicknamed "BioScavenger." It will be designed to provide protection from the toxic effects of certain chemical warfare agents.
"Patients get paralyzed and they end up not being able to breathe," said Terry Irgens, DVC's president.
Butyrylcholinesterase normally is found in human serum, and a concentrated form of the enzyme has been shown to be effective. The company plans to complete a Phase I study of the candidate by the end of the two-year contract.
"We're on a very tight timeline to stay within this schedule," Irgens said, "and because of the sense of urgency for these types of products."
DVC (formerly DynPort Vaccine Co.) has developed products to protect against biowarfare since 1997. El Segundo, Calif.-based Computer Sciences Corp. acquired the company last year. MITS manages the development of products used to prevent, treat and diagnose chemical and biological warfare agent exposure in U.S. military personnel.
News of the contract comes about two months after DVC received FDA approval of its vaccinia immune globulin (VIGIV) to address serious side effects of the smallpox vaccine. (See BioWorld Today, Feb. 24, 2005.)
The biologics license application for VIGIV consisted of data that showed no serious adverse events among healthy volunteers who received up to 500 mg per kilogram of body weight.
Due to the nature of many DVC products, it is not possible to test their efficacy in late-stage clinical trials. Approval of a BioScavenger-type product would require Phase I, II and III safety studies, as well as efficacy studies that are not conducted in humans.
"You have to have the same amount of safety data from these products as any other product," Solow told BioWorld Today. "But you cannot test for efficacy in humans, of course, so you have to develop alternative models to measure whether it works or not in terms of nerve gas exposure."
DVC will test BioScavenger in animals to collect its efficacy data.
Separately, on Tuesday, DVC signed a contract with Sydney, Australia-based Life Therapeutics to provide the vaccinia hyperimmune plasma used to make vaccinia immune globulin. The plasma will be supplied by Life Sera, an Atlanta-based division of Life Therapeutics. The contract is worth up to $1.6 million to Life Therapeutics (formerly Gradipore Ltd.).