�New stage IIb data from Tibotec
Pharmaceuticals Ltd. provides additional information on the safety and
efficaciousness of TMC278, the company's once-daily, investigational
non-nucleoside reverse transcriptase inhibitor (NNRTI), as part of HIV
combination therapy in treatment-naive adults. These findings were
presented today at the International AIDS Conference (AIDS 2008) in Mexico
City.
Seventy-six percent of patients receiving the 25 mg dosage of TMC278,
which is being studied in phase III trials, achieved an undetectable viral
load (
"NNRTIs have been an integral section of combination antiretroviral
therapy for over a decennium," said clinical trial investigator Peter Shalit,
M.D. Swedish Medical Center, Seattle, WA. "The phase IIb information show
potential difference for TMC278 as a once-daily discussion option for patients wHO have
non previously taken anti-HIV medications."
TMC278 is an investigational product, and the safety and efficaciousness of
it, in combination with other antiretroviral agents, has non been
established. Two major phase III trials for TMC278 ar being conducted in
Africa, Asia, Europe, North America and South America, and are currently
recruiting treatment-naive adult patients.
Study Design
The phase IIb dose-finding study (TMC278-C204) evaluated the efficaciousness,
tolerability and safety of once-daily TMC278 at threesome blinded doses (25 mg,
75 mg, and cl mg) and included an open label EFV 600 mg sleeve. A add up of
368 patients were randomised to receive one of the three doses of TMC278 or
EFV, and all patients standard a background regimen of two nucleoside
reverse transcriptase inhibitors (NRTIs), zidovudine + lamivudine (AZT/3TC)
or tenofovir + emtricitabine (TDF/FTC).
Safety Results
Of patients in the TMC278 combined group compared with EFV, 9 per centum
vs. 21 percent experienced rash, 31 percent vs. 48 percentage experienced
flighty system untoward events and 16 per centum vs. 21 percent experienced
psychiatric events.
Overall, patients in the TMC278 combined group (all doses) vs. the EFV
group experienced similar incidences and types of dangerous adverse events
(SAEs) (12 percent vs. 15 pct), grade 3 or 4 adverse events (AEs), (27
percent vs. 21 percentage) and grade 3 or 4 lab abnormalities (26
percent vs. 24 pct).
TMC278 is the third anti-HIV compound to be developed by Tibotec
Pharmaceuticals, which 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 ontogeny 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 Pharmaceuticals Ltd.
http://www.tibotec.com
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