Mexico City, Mexico (ots/PRNewswire) -
- Ninety-Six-Week Data on Tibotec Investigational NNRTI Presented
at AIDS 2008
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-naïve 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 +
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 (<50 HIV-1 RNA copies/mL) at week 96 compared with 71
percent of patient receiving EFV.
Overall, treatment emergent adverse events were comparable in the
TMC278 combined group vs. the EFV group with no significant
difference in discontinuation rates (12 percent vs. 9 percent).
Incidences and types of serious adverse events (SAEs) (12 percent vs.
15 percent), grade 3 or 4 adverse events (AEs), (27 percent vs. 21
percent) and grade 3 or 4 laboratory abnormalities (26 percent vs. 24
percent) were also similar in the TMC278 combined group vs. the EFV
The most common AEs related to TMC278 or EFV were nausea (36
percent vs. 29 percent), headache (20 percent vs. EFV 16 percent) and
upper respiratory tract infection (15 percent vs. 8 percent).
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
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 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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