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ContraVir Expands Patient Enrollment Criteria For Ongoing Final Stage Clinical Trial Of FV-100 For Treating Shingles


ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV) revealed Thursday that it amended the clinical trial protocol for its ongoing final stage trial of its novel antiviral candidate FV-100, which is in development to prevent the debilitating shingles-associated pain known as post-herpetic neuralgia (PHN). According to the company, the protocol was amended to accurately represent the changing shingles population as witnessed in clinical practice and enroll the most clinically relevant patients into the trial.

ContraVir's Chief Medical Officer, John Sullivan-Bolyai, commented, "Recent data show that the average age of shingles patients is now approximately 50 years, which is significantly younger than it has been historically, and it is important for our trial to be aligned with the current patient population."

He added, "Furthermore, the majority of patients do not immediately recognize and seek medical treatment for shingles symptoms, rather opting to 'wait and see' if the symptoms get worse while taking at-home therapies such as analgesics or topical steroids. It was necessary to remove certain exclusion criteria from our protocol in order to account for these clinically relevant patient behaviors, which more accurately represent how patients arrive at the clinic with a potential shingles diagnosis."

The company indicated that under the amended protocol, the minimum age of male, as well as, female patients who could be enrolled in the trial was lowered to 30 years from 50, which reflected the age at which many patients currently get shingles. Moreover, trial investigators may now enroll patients who present with shingles within five days of lesion appearance, where previously it had been restricted to within three days, allowing a more realistic window of time for patients to recognize shingles symptoms and seek treatment.

On Wednesday, the stock advanced 2.17 percent.

Posted-In: Biotech News FDA General


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