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Inhibitex Initiates Phase II Clinical Trial of FV-100 for the Treatment of Shingles
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Inhibitex, Inc. has announced that it has initiated a Phase II clinical trial with FV-100, its oral antiviral compound in clinical development for the treatment of herpes zoster (shingles).
The Phase II clinical trial is a well-controlled, double-blind study evaluating FV-100 against an active control (valacyclovir). Approximately 350 patients, aged 50 years and older, will be equally randomized to one of three treatment arms: 200 mg FV-100 administered once daily; 400 mg FV-100 administered once daily; and 1,000 mg valacyclovir administered three times per day.
In addition to further evaluating its safety, the objective of the trial is to evaluate the therapeutic benefit of FV-100 in reducing: the severity and duration of shingles-related acute pain; the incidence of post herpetic neuralgia (PHN); the time to lesion healing; and the use of concomitant pain medications.
“We are pleased to have commenced this well-powered Phase II trial, in which we will evaluate the potential of FV-100 to treat shingles as compared to the current standard of care,” stated Russell H. Plumb, president and chief executive officer of Inhibitex, Inc.
“We plan to ultimately utilize a total of 50-60 U.S. sites in the trial, and we believe this enthusiastic response from the clinical community reflects its recognition of the significant unmet medical needs of the increasing number of shingles patients.”
The Phase II clinical trial is a well-controlled, double-blind study evaluating FV-100 against an active control (valacyclovir). Approximately 350 patients, aged 50 years and older, will be equally randomized to one of three treatment arms: 200 mg FV-100 administered once daily; 400 mg FV-100 administered once daily; and 1,000 mg valacyclovir administered three times per day.
In addition to further evaluating its safety, the objective of the trial is to evaluate the therapeutic benefit of FV-100 in reducing: the severity and duration of shingles-related acute pain; the incidence of post herpetic neuralgia (PHN); the time to lesion healing; and the use of concomitant pain medications.
“We are pleased to have commenced this well-powered Phase II trial, in which we will evaluate the potential of FV-100 to treat shingles as compared to the current standard of care,” stated Russell H. Plumb, president and chief executive officer of Inhibitex, Inc.
“We plan to ultimately utilize a total of 50-60 U.S. sites in the trial, and we believe this enthusiastic response from the clinical community reflects its recognition of the significant unmet medical needs of the increasing number of shingles patients.”
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