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13 May 2010
The first clinical trials have started on a new investigational drug, discovered by researchers at Cardiff University, which is being developed to treat infections caused by Hepatitis C virus.
Approximately 170 million people worldwide are affected with Hepatitis C, which can lead to liver cancer, cirrhosis and death. It is the leading cause of liver transplantation in western countries. The current treatment involves two drugs – ribavirin and interferon, which has to be given as an injection. Side effects are often severe and lead to patients failing to complete the treatment.
The new drug, INX-189, is taken orally and was first prepared at the Welsh School of Pharmacy in November 2008. Laboratory tests showed it killed 90 per cent of the virus at very low (nanomolar) concentration, making it one of the most potent compounds of its kind developed to date.
US pharmaceutical company Inhibitex, which owns the licence to INX-189 and has been working with the Cardiff team, has now started trials in healthy volunteers to assess the compound’s safety. A second trial, which would evaluate the compound’s effectiveness on Hepatitis patients, may follow later this year.
Professor Chris McGuigan of the Welsh School of Pharmacy, academic lead on the project, said: "This is still a very early stage of the trials process. However, progress has been encouraging so far, going from the laboratory to human trials within 18 months. We believe that INX-189 offers the possibility of more potency against Hepatitis, more rapid action in the liver, and fewer side effects than existing treatments."
Cardiff University and Inhibitex filed a patent on INX-189 earlier this year. It has been cleared for human clinical trials by the Food and Drug Administration in the US
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Professor Chris McGuigan,Welsh School of Pharmacy,Cardiff University,Telephone +44 029 2087 4537Email: email@example.com
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Inhibitex has initiated a Phase I double-blind, placebo-controlled, single ascending dose study to evaluate the safety and pharmacokinetic activity of INX-189 in healthy volunteers under an IND that it filed earlier this year with the FDA. The study, which is being conducted in the U.S., will evaluate up to six escalating doses of INX-189, ranging from 3 mg up to200 mg. Each dose cohort will include eight subjects, six of which will receive INX-189 and two that will receive placebo.
Inhibitex is developing a series of proprietary protides of nucleoside inhibitors that target the RNA-dependent RNA polymerase (NS5b) of HCV. The Company believes that its protides possess several pharmacological advantages over nucleosides alone, including greater potency, a more rapid conversion into its active form in the liver and potentially less toxicity due to reduced systemic exposure of the nucleoside. INX-189 is a protide of a 2’-C-methylguanosine analogue, which the Company believes is the most potent HCV nucleotide polymerase inhibitor described in the literature to date. The Company believes that preclinical studies of INX-189 support its potential as a highly potent, once-per-day oral therapy highly amenable to combination with other antivirals for the treatment of patients with chronic hepatitis C infection.Cardiff UniversityCardiff 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
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