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news.ContraVir Pharmaceuticals (CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced that the first patient has been enrolled in the company's pivotal Phase III clinical study, study 007, of FV-100 to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN).
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The first patient in the study enrolled at Center for Clinical Studies in Houston, Texas. The study will build upon prior clinical results for FV-100, including Phase 1 trials and a large Phase 2 clinical trial in shingles patients, which demonstrated favorable safety and tolerability for FV-100.
James Sapirstein, CEO of ContraVir, commented, "We are pleased to enroll the first patient in the Phase 3 study and to move forward in our efforts to develop treatment options for patients with shingles and acute shingles-associated pain. The enrollment is an important milestone for ContraVir as we advance our current pipeline as this brings us one step closer to commercialization."
The pivotal study 007 will compare FV-100 to valacyclovir (Valtrex) with the reduction in the incidence of shingles-associated pain, PHN, as a primary endpoint.
It is a multi-center, randomized, double-blind, parallel-group, comparative study in up to 200 centers in the U.S. The study is comprised of three arms: FV-100 400mg QD, FV-100 400mg BID, and valacyclovir 1000mg TID.
Approximately 825 patients are expected to be analyzed for a seven-day treatment period, and follow up through day 120.
Stephen Tyring, M.D., Ph.D., the primary investigator of study 007, added, "We are proud to acknowledge that the first patient entered the trial from one of our network clinics. We believe this is an important study in our continuing efforts to improve the lives of shingles patients all over."