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Home » TIBOTEC EXPANDS ACCESS TO INVESTIGATIONAL NNRTI
TIBOTEC EXPANDS ACCESS TO INVESTIGATIONAL NNRTI
September 26, 2006
Tibotec Pharmaceuticals announced that the expanded access program for TMC125, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), has opened in the U.S. and will open shortly in Canada and Europe, subject to the necessary approvals. The program will provide access to HIV-1 infected patients who need the compound to construct a viable treatment regimen. TMC125 is a next-generation NNRTI active against NNRTI-resistant strains of HIV. The Phase III clinical trials (DUET 1 and 2) in treatment-experienced HIV-1 infected patients are ongoing and have recently completed enrollment. The safety and efficacy of TMC125 in combination with other antiretroviral (ARV) agents have not been established.
"We know that many people living with HIV/AIDS have limited treatment options because of the increasingly significant issue of viral resistance, and we are working to provide eligible individuals with access to TMC125 as soon as possible through this program," said Roger Pomerantz, president of Tibotec R&D.
The TMC125 EAP is available to HIV-1 infected adults, at least 18 years old, who have limited treatment options either due to virological failure or intolerance to multiple ARV regimens. Patients must be three-class experienced, having received licensed treatment from each of the three major oral classes of anti-HIV drugs, and must have received at least two protease inhibitor-based regimens.
Tibotec has received fast-track designation for TMC125 from the FDA. The decision was based on findings from Phase II data from clinical studies of TMC125 in treatment-experienced HIV-1 infected patients as well as results from in vitro studies indicating TMC125's antiviral activity against HIV-1 strains resistant to currently marketed NNRTIs.
KEYWORDS Drug Pipeline Alert
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