New phase IIb data from Tibotec Pharmaceuticals Ltd. show that TMC278,
the company's once-daily, investigational non-nucleoside reverse
transcriptase inhibitor (NNRTI), provides long-term efficacy and tolerability
in treatment-na??ve adults with HIV. Ninety-six-week study results showed that
more than 70 percent of patients receiving TMC278, plus a background regimen,
achieved a confirmed and sustained undetectable viral load (defined as < 50
HIV RNA copies/mL). These findings were presented today at the International
AIDS Conference (AIDS 2008) in Mexico City.
"The phase IIb data show great potential for TMC278 as a once-daily
treatment option for patients who have not previously taken anti-HIV
medications," said clinical trial investigator Anton Pozniak, M.D., Chelsea
and Westminster NHS Foundation Trust, London, UK. "We are continuing to
investigate this promising once-daily therapy in two pivotal phase III
trials, which will be conducted in Africa, Asia, Europe, North America and
South America."
The phase IIb dose-finding study (TMC278-C204) evaluated the efficacy and
tolerability of once-daily TMC278 at three doses (25 mg, 75 mg, and 150 mg
once daily) and included an open label efavirenz (EFV) 600 mg once daily arm.
A total of 366 patients were randomised to receive TMC278 (N= 277) or EFV (N=
89), and all patients received a background regimen of two nucleoside reverse
transcriptase inhibitors (NRTIs), zidovudine + lamivudine (AZT/3TC) or
tenofovir + emtricitabine (TDF/FTC).
Efficacy Results
At all three TMC278 doses, more than 70 percent of patients achieved an
undetectable viral load at week 96. These findings were comparable to the EFV
treatment group. Specifically, 76 percent of patients receiving the 25 mg
dose of TMC278, which will be used in phase III studies, reached a confirmed
and sustained undetectable viral load (
The incidences of rash, nervous system disorders, psychiatric disorders,
headache and insomnia were 9, 31, 16, 20 and 7 percent for the TMC278
combined group, and 21, 48, 21, 16 and 6 percent for the EFV group.
TMC278 is the third anti-HIV compound to be developed by Tibotec
Pharmaceuticals; another NNRTI is under investigation in treatment
experienced adults with HIV and a protease inhibitor is currently indicated
for treatment-experienced adults with HIV. Tibotec Pharmaceuticals is also
developing 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, Pennsylvania,
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
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
sec, jnj 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.