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Tibotec Announces Start of TMC125 Phase III Trials Innovative trial design offers two investigational antiretrovirals in combination
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Press announcement from Tibotec
Co CORK, Ireland, November 17, 2005 - Tibotec Pharmaceuticals Ltd. announced today the opening of its pivotal phase III clinical trial program for its investigational non-nucleoside reverse transcriptase (NNRTI), TMC125. The program comprises two randomized, placebo-controlled trials in treatment-experienced HIV-1 infected adult patients with documented NNRTI resistance and at least 3 primary protease mutations. The two clinical trials of 600 patients each will be carried out in 18 countries.
In these studies, the background protease inhibitor (PI) will be Tibotec's investigational PI, TMC114. This pioneering trial design will be the first time that two new investigational antiretrovirals have been studied together in combination in heavily treatment experienced patients. The Antiviral Division of the U.S. Food and Drug Administration (FDA), the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) and the HIV patient community are supportive of this design.
Currently approved NNRTIs lose their antiviral activity in the presence of a single NNRTI mutation. TMC125 has shown activity in vitro against NNRTI-resistant virus. The first long-term clinical results of TMC125 in HIV-1 patients with NNRTI resistance will be presented as two late-breaker oral presentations at the European AIDS conference, 17-20th November in Dublin, Ireland. TMC125-C223 was a phase 2b dose-ranging, randomized, partially-blinded study in HIV-1 infected patients with substantial treatment experience and documented evidence of NNRTI resistance and 3 or more protease mutations. Despite the patients' NNRTI resistance, the viral load reduction in patients receiving TMC125 was significantly greater than in the active control at the 24-week primary endpoint. The mean change from baseline in viral load was -1.04, -1.18 and -0.19 log10 copies/ml in the TMC125 400 and 800 mg bid and active control groups, respectively
TMC125-C203 was a Phase II dose-escalation trial in which the primary objective was to assess the safety and tolerability of TMC125. The most common adverse events (AEs) were diarrhoea, headache, rash and nausea with the incidence of AEs not substantially different between TMC125 and placebo.
"We know that many people living with HIV/AIDS have run out of treatment options because of the growing problem of viral resistance. Preliminary data suggests TMC125 has the potential to be the first NNRTI active against these resistant strains," said Brian Woodfall, M.D., Global Medical Leader TMC125.
TMC125 has received Fast Track designation from the US Food and Drug Administration; such designation is conferred on drugs that are intended for the treatment of serious or life-threatening conditions.
Tibotec Pharmaceuticals Ltd.: Research & Development:
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium.
Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and superior anti-infectives for diseases of high unmet medical need.
For further information, please visit: www.tibotec.com
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