Tibotec Pharmaceuticals Ltd.

48 Week Data on Investigational Antiretroviral TMC125 From Tibotec

    Toronto (ots/PRNewswire) -

    - TMC125 a Next-Generation NNRTI

    Tibotec Pharmaceuticals Ltd. presented 48 week efficacy and safety data on TMC125, a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI), at the 16th International AIDS conference (IAC), AIDS 2006, in Toronto, Canada this week. TMC125 is currently being investigated in phase 3 trials (DUET 1 and 2) in treatment-experienced adult patients.

    TMC125 showed activity against NNRTI-resistant virus

    The presented data were the final 48 week analysis of study TMC125-C223, a phase 2b dose-finding, randomized, partially-blinded study in HIV-1 infected adult patients with substantial treatment experience, documented evidence of NNRTI resistance and 3 or more PI mutations. A total of 199 patients were randomized to TMC125 (400 mg or 800 mg bid) (n=159) plus background regimen or best available control regimen (n=40). Ninety eight percent of control group patients had discontinued treatment by 48 weeks, compared with 38% of TMC125 patients.

    Intent to treat analysis showed that the mean change from baseline in viral load at week 48 was -0.88, -1.01 and -0.14 log10 copies/ml in the TMC125 400mg and 800 mg bid and active control groups respectively. A decrease from baseline in plasma viral load of at least 1 log10 copies/ml was achieved by 31%, 34% and 8% of patients respectively. In these patients with NNRTI resistance, the viral load reduction in patients receiving TMC125 400mg or 800mg bid in combination with an optimized background regimen (OBR) was significantly greater than in the active control at 48 weeks, p=0.018 and p=0.002 respectively.

    "These 48 week results in patients with NNRTI-resistance with limited treatment options are encouraging," said Dr Cal Cohen, Research Director, CRI New England and Harvard Vanguard Medical Associates, Boston, MA.

    The comparison of adverse events (AEs) and serious AEs (SAEs) between the TMC125 arms and the control group is confounded because by 48 weeks 98% of patients in the control group had discontinued, the majority for poor virologic response. The most common adverse events (AEs) were diarrhea, pyrexia and rash which were 22%, 20% and 20%, respectively, for the TMC125 groups compared with 15%, 10% and 8% for the active control group. Overall, 27% of TMC125 and 18% of control patients reported at least one serious adverse event; 4 of these SAEs were classified as possibly related to TMC125.

    Sixteen presentations by Tibotec Pharmaceuticals Ltd. and its collaborators provided new safety and efficacy, pharmacokinetic and drug interaction data on the Tibotec compounds -- including the investigational agents TMC125, TMC278 and TMC120.

    For further information, please visit: http://www.tibotec.com

    Tibotec Pharmaceuticals Ltd.

    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 with offices in Yardley, PA. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.

    Tibotec is developing a Global Access Program to facilitate access to its antiretrovirals for patients living with HIV/AIDS in developing countries. The Global Access Program for PREZISTA(TM) (darunavir, also known TMC114) includes access, pricing, registration, medical education for appropriate use and voluntary licensing.

    IAC Presentations

    Cal Cohen, et al. 48-week efficacy and safety results of TMC125 in HIV patients with NNRTI and PI resistance - study TMC125-C223

    Howard Grossman, et al. Prediction of clinical benefits of TMC125 from treatment effects on CD4 counts and HIV RNA

    Monika Scholler, et al. Lack of interaction between TMC125 and methadone

    Monika Scholler, et al. TMC125 bioavailability is not affected by ranitidine and omeprazole

    Julio Montaner, et al. Combination of TMC114/ritonavir and TMC125 in patients with multidrug resistant HIV

    Thomas Kaduda, et al. The pharmacokinetic interaction between TMC125 and TMC114/rtv in HIV-negative volunteers

    Rolf Van Heeswijk, et al. The pharmacokinetic interaction between ketoconazole and TMC278, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in healthy HIV-negative subjects

    J. Romano, et al. Characterization of in vitro release and in vivo delivery of TMC120 with an intravaginal ring: implications for microbicide delivery

    Web site: http://www.tibotec.com

ots Originaltext: Tibotec Pharmaceuticals Ltd.
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
Karen Manson, cell: +32-479-89-47-99, for Tibotec Pharmaceuticals
Ltd.



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