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Recruitment Ongoing in Europe for Two Tibotec Phase III Clinical Trials Studying TMC278 in Treatment-Naïve HIV-Infected Adults
Cork, Ireland (ots/PRNewswire) -
- Once-Daily TMC278 is the Third Anti-HIV Compound to be Developed in Tibotec Virology Portfolio
Tibotec Pharmaceuticals is currently recruiting HIV-positive, treatment-naïve adults (or those who have never taken antiretroviral medication before) in Europe for two major phase III efficacy trials examining TMC278, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI). The global trials, which involve 13 European countries, compare the efficacy, safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV), each co-administered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in treatment-naïve HIV-infected adults.
"We are encouraged by preliminary data, which have shown TMC278 to be active against HIV in patients who have not previously received treatment," said Roger Pomerantz, MD, President of Tibotec Research and Development. "These phase III studies will provide additional information on the safety and efficacy of this potential new treatment option."
The first phase III, double-blind, randomized study, known as TMC278-C209 or ECHO (Efficacy Comparison in treatment-naïve HIV-infected subjects Of TMC278 and EFV), evaluates 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), evaluates 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 is being conducted at more than 100 sites in over 20 countries, including Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Romania, Russia, Spain, Sweden and the UK, and others in Africa, Asia, Latin America and North America. The trials each seek to enroll approximately 680 patients. To be eligible, patients must have a viral load higher than 5,000 HIV-1 RNA copies/mL at screening and must never have taken anti-HIV drugs prior to enrolling, as well as meet other eligibility criteria. The primary endpoint of the studies is to assess the proportion of patients with a confirmed plasma viral load < 50 HIV-1 RNA copies/mL at week 48 on TMC278 vs. control (EFV). The studies will last for a maximum duration of 106 weeks, which includes a maximum of a six-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 European Medicines Agency (EMEA) as part of the Marketing Authorisation Application for TMC278.
Through the application of its thorough understanding of virology and viral resistance, Tibotec has become an established leader in HIV/AIDS, having developed and made available two antiretroviral agents for the treatment of HIV. TMC278 is the third anti-HIV compound to be developed by Tibotec Pharmaceuticals, which is also developing other investigational compounds for the treatment of hepatitis C and tuberculosis.
About Tibotec Pharmaceuticals
Tibotec Pharmaceuticals, 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, USA. 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.
ots Originaltext: Tibotec Pharmaceuticals Ltd.
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