Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 In Treatment-Naive Adults With HIV

Main Category: HIV / AIDS
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 22 Jul 2008 - 2:00 PDT

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Tibotec Pharmaceuticals Ltd. announced that two major phase III efficacy trials examining TMC278, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in treatment-naive adults with HIV-1, are now recruiting patients. The global trials will compare the efficacy, safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV), each coadministered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in treatment-naive HIV-1-infected adults.

"Preliminary data have shown TMC278 to be active against HIV for patients who have not previously received treatment," Roger Pomerantz, MD, President of Tibotec Research and Development. "These phase III studies will provide important information on the safety and efficacy of this potential new treatment."

The first phase III, double-blind, randomized study, known as TMC278-C209 or ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV), will evaluate TMC278 (25 mg) once daily oral tablet versus EFV (600 mg) once daily, when combined with a fixed background regimen consisting of emtricitabine + tenofovir disoproxil fumarate. A second phase III, double-blind randomized study, known as TMC278-C215 or THRIVE (TMC278 against HIV, in a once daily RegImen Versus Efavirenz), will evaluate TMC278 (25 mg) once daily versus EFV (600 mg) once daily, when combined with an investigator-selected background regimen consisting of two N[t]RTIs (abacavir + lamivudine or tenofovir disoproxil fumarate + emtricitabine or zidovudine + lamivudine).

Each study will be conducted at more than 100 sites in over 20 countries, including the U.S., Canada and several countries in Latin America, among others, and will seek to enroll approximately 680 patients. To be eligible, patients must have a viral load greater than 5,000 copies/mL at screening and may not have taken any anti-HIV drugs prior to enrolling, as well as meet other screening criteria. The primary endpoint of the studies is to assess the proportion of patients with viral load < 50 copies/mL at week 48 on TMC278 vs. control (EFV). The studies will last for 104 weeks, which includes a four-week screening period, a 96-week treatment period and a four-week follow-up period.

Results from both of these studies will be submitted to the U.S. Food and Drug Administration (FDA) for consideration for approval of TMC278.

TMC278 is the third anti-HIV compound to be developed by Tibotec Pharmaceuticals. Tibotec Pharmaceuticals is also developing other investigational compounds for the treatment of hepatitis C and tuberculosis.

About 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 a member of the Johnson & Johnson family of companies.

Forward Looking Statement

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Tibotec's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. Copies of this Form 10-K, as well as subsequent filings, are available online at http://www.sec.gov, http://www.jnj.com or on request from Johnson & Johnson. Tibotec does not undertake to update any forward-looking statements as a result of new information or future events or developments.

Tibotec Pharmaceuticals Ltd.
http://www.jnj.com