COMUNICADO de Tibotec-Virco

FDA completes IND review for Tibotec-Virco's candidate anti-HIV drug,

TMC125

Tibotec-Virco to initiate phase I clinical trial in the US

MECHELEN, Belgium, 18 Dic. (PRNewswire) -

Tibotec-Virco announced that the US 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 a very 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 US 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-naïve 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 favourable binding interactions

with mutant HIV strains as well as the wild-type virus. TMC125 has

been shown 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 viral diseases

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

The Company has two novel anti-retroviral 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

Source: Tibotec-Virco

Contact: Karen Manson, VP Corporate Communications, Tibotec-Virco NV,

Mobile: +32 479 89 47 99, Email: karen.manson@tibotec-virco.com Neil

Graham, MD, VP Medical Department, Tibotec-Virco + 1 919 201 1915

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