AEGiS-PRn: FDA Completes IND Review for Tibotec-Virco's Candidate Anti-HIV Drug, TMC125: Tibotec-Virco To Initiate Phase I Clinical Trial in the U.S.

Important note: Information in this article was accurate in 2001. The state of the art may have changed since the publication date.

FDA Completes IND Review for Tibotec-Virco's Candidate Anti-HIV Drug, TMC125: Tibotec-Virco To Initiate Phase I Clinical Trial in the U.S.

PRNewswire - December 18, 2001

MECHELEN, Belgium, Dec. 18 /PRNewswire/ -- Tibotec-Virco announced that the U.S. Food and Drug Administration (FDA) has completed its review of the company's Investigational New Drug application (IND) for its candidate drug. TMC125 is a novel next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI). Tibotec-Virco will shortly initiate a phase I clinical trial with TMC125.

"This is an important milestone for Tibotec-Virco," says CEO, Philippe Ballero. "The initiation of the phase I clinical trial for Tibotec-Virco's candidate NNRTI is the company's first effort in the U.S. in drug development."

Phase I and IIa studies of TMC125 have previously been undertaken in Europe. The first clinical results of a short-term proof-of-concept study in treatment-naive patients were presented at the recent ICAAC conference in Chicago.

The ability of HIV to develop mutant strains that are resistant to HIV drugs is one of the main reasons why people living with HIV experience treatment failure. In response to the emerging need for new therapeutics, Tibotec-Virco has developed and implemented a unique parallel drug profiling strategy to accelerate drug discovery and development by rapidly identifying new anti-HIV compounds, which in vitro are highly active against both wild type and resistant HIV.

TMC125 is a DAPY (diaminopyrimidine) compound, which is highly flexible. This flexibility results in favorable binding interactions with mutant HIV strains as well as the wild-type virus. TMC125 has been shown in in vitro studies to be highly active against strains of HIV that are resistant to current NNRTIs.

"The company is committed to implementing a clinical program in the United States," said Neil Graham, MD, VP Medical Department, Tibotec-Virco, North Carolina. "We are excited that our anti-HIV therapeutic pipeline may herald improved treatment options for persons living with HIV/AIDS."

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 chronic viral diseases with the ultimate aim of enhancing and extending peoples' lives.

The Company has two novel antiretroviral compounds in clinical development, TMC125, a non-nucleoside reverse transcriptase inhibitor (NNRTI) and TMC114, a protease inhibitor (PI).

Tibotec-Virco is focusing on the discovery and development of HIV/AIDS compounds that are active against both wild-type and strains of HIV that have developed drug resistance, a major cause of treatment failure.

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 120,000 HIV genotypes and phenotypes. The VirtualPhenotype(TM) test combines the best features of both genotyping and phenotyping by using information from this immense database. It provides physicians with comprehensive, accurate and cost-effective resistance information for improved patient management.

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.

For further information, please visit Tibotec-Virco's website: http://www.tibotec-virco.com

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