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16 December 2010
FV-100, the anti-shingles drug developed in collaboration with Professor Chris McGuigan's research group at the Welsh School of Pharmacy, had promising results in its phase 2 trial, pharmaceutical company Inhibitex has reported.
Inhibitex announced that they had achieved clinical 'proof-of-concept' in shingles patients.
The study, the first clinical trial to assess the antiviral activity of FV-100, involved 350 shingles patients. It compared FV-100 to an active control, valacyclovir, one of the most commonly-used antiviral drugs to treat shingles. FV100 was given once-daily while valacyclovir was given 3 times a day.
Shingles is a viral infection, with an estimated 2.5M new cases every year. It is generally characterized by skin lesions or rash, acute infection-related pain, and in many cases, post herpetic neuralgia, which is a painful and often debilitating chronic complication which can last for months or possibly years.
Favourable treatment differences were observed for two doses of FV-100 (200mg or 400mg) compared to valacyclovir (3 x 1000mg) for the severity and duration of shingles-associated acute pain over the first 30 days post-infection. There were also favourable treatment differences observed on other points, including the reduction in the severity and duration of shingles-associated pain over 90 days and the incidence of post herpetic neuralgia. The treatment differences observed between either of the FV-100 cohorts and the valacyclovir-treated subjects were not statistically significant. FV-100 was generally well tolerated at both dose levels, and demonstrated a similar adverse event profile as compared to valacyclovir. Further details of the results of the trial are published on the Inhibitex web-site.
Professor McGuigan said: "The successful completion of this pivotal phase 2 trial marks an important turning point in the development of FV100 as a new drug for shingles. The data from this study showed the efficacy of this drug, which now has a good chance to emerge as a new medicine for this devastating disease.".
Professor Gary Baxter, Head of the Welsh School of Pharmacy, commented: "The Welsh School of Pharmacy has long history of innovative pharmaceutical scientific research but we are especially proud of Professor McGuigan and his colleagues on this landmark achievement. The successful clinical trial of a drug invented in this School is a very significant event and a perfect example of our key mission: discovery with the purpose of alleviating human suffering."
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