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Cymraeg

Clinical trials for Shingles drug take an important step forward

11 May 2009

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."

Notes to editors:

For more information contact
Professor Chris McGuigan
Professor of Medical Chemistry, Welsh School of Pharmacy

T: 02920 874 537
E: mcguigan@cardiff.ac.uk

For more media information contact

Lowri Jones
Public Relations
Cardiff University

T: 02920 870 995
E: joneslc3@cardiff.ac.uk

Notes to editors

Cardiff University

Cardiff University is recognised in independent government assessments as one of Britain’s leading teaching and research universities and is a member of the Russell Group of the UK’s most research intensive universities. Among its academic staff are two Nobel Laureates, including the winner of the 2007 Nobel Prize for Medicine, Professor Sir Martin Evans.

Founded by Royal Charter in 1883, today the University combines impressive modern facilities and a dynamic approach to teaching and research. The University’s breadth of expertise in research and research-led teaching encompasses: the humanities; the natural, physical, health, life and social sciences; engineering and technology; preparation for a wide range of professions; and a longstanding commitment to lifelong learning.

Visit the University website at: www.cardiff.ac.uk

Welsh School of Pharmacy

The Welsh School of Pharmacy, which was founded in 1919, is the only school of pharmacy in Wales. For nearly a century, the School has cultivated a strong tradition of innovative pharmaceutical education, scientific research and service to the pharmacy profession, especially in Wales.

The School is recognised in independent government assessments as one of the top UK schools of pharmacy.

There are more than 40 members of full-time staff and a very active undergraduate student organisation WPSA - the Welsh Pharmacy Students Association. Pharmacy teaching at Cardiff frequently features at the top of national league tables of excellence.

Research in the Welsh School of Pharmacy in Cardiff currently encompasses aspects of all facets of the study of drugs, including: the discovery of new potential drug entities, using synthetic chemistry; formulation of drugs to achieve targeted responses; pharmacological studies of mechanisms of drug action; as well as researching elements of current medical and pharmaceutical practice.

The School also oversees the activities of the Welsh Centre for Pharmacy Professional Education, which is concerned with continuing education for all of Wales’ 2,100 pharmacists.

About Shingles and FV-100

Shingles, also known as herpes zoster, is an infection caused by the reactivation of varicella zoster virus (VZV), the same virus that causes chicken pox. Worldwide, it is estimated that there are greater than 2.5 million cases of shingles each year. While shingles can develop in adolescents or adults of any age, it occurs predominantly in those 40 years of age and older.

Published in vitro studies have demonstrated that FV-100, an orally available bicyclic nucleoside analogue, is more potent against VZV and can inhibit its replication substantially faster than any other antiviral agent currently approved for the treatment of shingles.

About Inhibitex

Inhibitex, Inc., headquartered in Alpharetta, Georgia, is a biopharmaceutical company focused on developing products to treat serious infectious diseases. In addition to FV-100, the Company’s pipeline includes a series of HCV nucleoside polymerase inhibitors and HIV integrase inhibitors in preclinical development. Inhibitex has also licensed the use of its proprietary MSCRAMM® protein technology to Wyeth for the development of staphylococcal vaccines. For additional information about the Company, please visit www.inhibitex.com.

For additional information about Inhibitex, please visit www.inhibitex.com

PHRMY1 - Phase2shingles