TMC125 demonstrates strong antiviral effect in HIV

October 29, 2001

First clinical results in short-term study are promising

ATHENS, Greece; Monday 29th, October 2001 - Data presented today at the 8th European Conference on Clinical Aspects and Treatment of HIV Infection (ECCATH) demonstrate an average reduction in the amount of HIV in patients' plasma (viral load) of 99% after one week of treatment using Tibotec-Virco's novel, new candidate drug TMC125, a potent non-nucleoside reverse transcriptase inhibitor.

Study C208 was a phase IIa double-blind, placebo-controlled trial examining the safety and efficacy of TMC125 monotherapy in 18 previously untreated HIV-positive individuals over one week. The trial was conducted in Moscow and St. Petersburg in Russia and all participants were offered open label state-of-the-art combination therapy after the one-week study.

"These are promising results for people living with HIV" said Joep Lange, MD, Head of the Antiviral Therapy Evaluation Center (IATEC) at the Academic Medical Center in Amsterdam. "These early results indicate that TMC125 has a rapid and strong antiviral effect in the short term. The challenge will now be to study the drug over a longer period of time to see if this early promise is fulfilled."

Researchers noted that while the average decrease in HIV viral load was 99%, some study participants experienced decreases of over 99.9%. The reductions in viral load ranged from 1.1 log up to 3.4 log. Eight of the 12 subjects who received TMC125 had their viral loads reduced to less than 400 copies of HIV/ml, with two subjects below the 50-copy limit of a more sensitive test. None of the subjects experienced any rebound in viral load during the short study period and there was no evidence of the development of drug resistance. TMC125 was very well tolerated during this study with no apparent differences in side effects between TMC125 and placebo.

"We are obviously delighted that TMC125 has performed so well in this study," commented Neil Graham MD, Vice President of the Medical Department, Tibotec-Virco. "These early clinical data suggest that TMC125 could become a major contributor to more effective HIV therapy in the future." Additional clinical trials are ongoing to study the use of TMC 125 in NNRTI-experienced patients. Previous laboratory research has demonstrated that TMC 125 and other NNRTIs under development at Tibotec-Virco are highly active against strains of HIV that are resistant to the current NNRTIs.

Background

Tibotec-Virco is a multinational biotechnology company with headquarters in Belgium and operating subsidiaries in the United States and Ireland.

Tibotec-Virco develops new drugs and individualised disease management products and services for HIV and other infectious diseases with the ultimate aim of enhancing and extending peoples' lives. The Company applies the latest techniques in drug discovery, pharmacogenomics, molecular biology, and artificial intelligence to its research and development programmes.

The company was formed from the merger of Virco Group NV and Tibotec Group NV on March 14, 2001 and brings together the complementary expertise of Tibotec in drug discovery and development and that of Virco in pharmacogenomics and molecular diagnostics.

The Company is focusing on the discovery and development of HIV/AIDS compounds that are active against strains of HIV that have developed drug resistance (a major cause of treatment failure). TMC125, a novel NNRTI, and TMC114, a protease inhibitor, are in clinical development.

Tibotec-Virco is widely regarded as a world leader in HIV resistance testing. The Company has built the world's largest relational database of more than 100,000 HIV genotypes and phenotypes; the VirtualPhenotype™ test, which combines the best features of both genotyping and phenotyping by using information from this immense database, has been developed to give physicians the most comprehensive, accurate and reliable resistance information available.
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For further information, please visit Tibotec-Virco's website: http://www.tibotec-virco.com

Cooney Waters Group, Inc.

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