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Tibotec Pharmaceuticals Ltd.

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.
For additional information on inclusion and exclusion criteria
for both of these studies, please see http://www.clinicaltrials.gov
or email  info@tibbe.jnj.com.
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.

Contact:

Media Contact: Hans Vanavermaete, Mobile: +32-478-44-72-78

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