Public Release: 

Clinical trials for shingles drug take an important step forward

Cardiff University

A possible new anti-viral drug designated FV-100, which could alleviate the suffering of millions of people with herpes zoster or shingles, has entered the second stage of clinical testing in patients.

Developed and patented by scientists based at Cardiff University, a Phase II clinical trial with FV-100 has recently been initiated in America. Previous research has shown the drug to be up to 10,000 times more potent than existing treatments in early lab tests.

The drug was discovered by a team in the Welsh School of Pharmacy and a virology group at the Rega Institute in Belgium, and is being further developed in collaboration with the U.S - based biopharmaceutical company, Inhibitex Inc. If it successfully demonstrates both safety and biological activity in this and subsequent trials, the treatment has the potential to improve the lives of over 2.5 million herpes zoster patients worldwide.

Shingles is caused by the same viral infection that causes chicken pox. It is estimated that around one in five people in the U.S., Europe and Japan will be affected by the debilitating condition during their lifetime. It is generally characterised by skin lesions, blisters and rash, and acute pain, and in many cases, post-herpetic neuralgia (PHN), which is a painful and often highly distressing condition resulting from nerve damage caused by the virus. Inhibitex believes FV-100 has the potential to reduce all of these symptoms.

Cardiff University's Professor of Medical Chemistry Chris McGuigan, who led the team which discovered the anti-viral drug said:

"We believe this drug has the potential to be the most powerful inhibitor ever discovered to treat shingles.

"Each year only 25 new medicines are approved for clinical use [worldwide or by the FDA]. Although FV-100 is early in its overall development plan, the chances of it becoming an approved medicine improves the further we successfully progress through each of the clinical stages. We are incredibly excited at the prospect of FV-100 becoming commercially available in the future, and potentially being the first drug discovered in Cardiff University to make it to the marketplace."

In Phase I trials of FV-100, Inhibitex reported no serious adverse events in healthy volunteers and data supported the potential for once-a-day dosing in future trials. Inhibitex anticipates completing its first Phase II trial of FV-100 in the first half of 2010.

Russell H. Plumb, president and chief executive officer of Inhibitex, Inc said: "We have more than 20 U.S sites qualified to enroll patients, and plan to ultimately utilise a total of 50-60 sites in this trial. 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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