Navigation Links
Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008
Date:8/5/2008

- Phase IIb study examines efficacy and safety of once-daily TMC278 in

treatment-naive adults with HIV-1 -

MEXICO CITY, Aug. 5 /PRNewswire/ -- New phase IIb data from Tibotec Pharmaceuticals Ltd. provides additional information on the safety and efficacy 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 dose of TMC278, which is being studied in phase III trials, achieved an undetectable viral load (<50 HIV-1 RNA copies/mL) at week 96 compared with 71 percent of patients receiving efavirenz (EFV). Of patients receiving the 75 mg and 150 mg doses of TMC278, 72 percent and 71 percent achieved an undetectable viral load, respectively.

"NNRTIs have been an integral part of combination antiretroviral therapy for over a decade," said clinical trial investigator Peter Shalit, M.D. Swedish Medical Center, Seattle, WA. "The phase IIb data show potential for TMC278 as a once-daily treatment option for patients who have not previously taken anti-HIV medications."

TMC278 is an investigational product, and the safety and efficacy of it, in combination with other antiretroviral agents, has not been established. Two major phase III trials for TMC278 are 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 efficacy, tolerability and safety of once-daily TMC278 at three blinded doses (25 mg, 75 mg, and 150 mg) and included an open label EFV 600 mg arm. A total of 368 patients were randomised to receive one of the three doses of TMC278 or EFV, and all patients received 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 percent vs. 21 percent experienced rash, 31 percent vs. 48 percent experienced nervous system adverse events and 16 percent 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 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).

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 development 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.

Media Contacts:

Karen Manson - 32-479-89-47-99

Pam Van Houten - 908-295-7367

Investor Relations Contacts:

Lesley Fishman - 732-542-3922

Louise Mehrota - 732-524-6491


'/>"/>
SOURCE Tibotec Pharmaceuticals Ltd.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV
2. AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
3. Medarex Announces Allowance of Investigational New Drug Application for Wholly-Owned Fully Human Anti-PD-L1 Antibody, MDX-1105
4. Meditrina Pharmaceuticals, Inc. Opens Investigational New Drug (IND) Application for Phase IIb Clinical Trial With MPI-676 in Endometriosis
5. Roche Moves Investigational Diabetes Drug, Taspoglutide, Into Phase III Clinical Trials
6. Banner Alzheimers Institute and Sun Health Research Institute Enrolling Local Patients in Study of Investigational Therapy to Treat Alzheimers Disease
7. Abbotts Phase III Sub-Group Analysis Shows Investigational TriLipix(TM) in Combination with CRESTOR(R) Improves Key Lipids in Patients with Mixed Dyslipidemia and Type 2 Diabetes
8. Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight
9. Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
10. Preliminary Data from Ongoing Phase 1 Data of Investigational Anti-PD-1 Antibody Presented at American Society of Clinical Oncology Annual Meeting
11. Phase III Study of Abbotts Investigational TriLipix(TM) in Combination With AstraZenecas CRESTOR(R) Meets Primary Endpoints on Key Lipids
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... BASEL , Schweiz, April 27, 2016 ... des Sachs CEO Forums in Zürich ... Phase-II-Studie ihres führenden Wirkstoffkandidaten STR001 zur Erhaltung ... (CI) eingesetzt wurde, bekannt. Für die umfassende ... Deutschland und Frankreich angeworben. STR001 wird während ...
(Date:4/27/2016)... , April 27, 2016   ... 42% Growth in Recurring Consumable Sales  Clinical ... Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of ... its sales for the first quarter ended March 31, ... the execution of its commercial strategy. First ...
(Date:4/27/2016)... ALBANY, New York , April 27, 2016 /PRNewswire/ ... new market report titled, "Skincare Devices Market - Global ... - 2023." According to the report, the global skincare ... 2014 and is anticipated to expand at a CAGR ... 17,299.4 Mn in 2023. Browse the full Skincare ...
Breaking Medicine Technology:
(Date:4/30/2016)... ... ... us, but there are things we can do to improve the odds of staying healthy for ... that there are simple, yet important steps that can be taken to maintain good health and ... her patients include;, , exercise , healthy diet , ...
(Date:4/29/2016)... ... 30, 2016 , ... World Patent Marketing , a ... an automotive invention that improves the storage features of a pick up truck. ... Scott Cooper, CEO and Creative Director of World Patent Marketing. "Over the next ...
(Date:4/29/2016)... , ... April 29, 2016 , ... In an ... and divorcee, shares her enthusiasm for Botox and lip injections, which she underwent in ... youth oriented Coachella Valley Music and Arts Festival. The article explains that Ms. Mirmelli’s ...
(Date:4/29/2016)... ... April 29, 2016 , ... Memorial ... for Graduate Medical Education (ACGME) that it has received accreditation for its residency ... of three residency programs that Memorial is currently pursuing, including Pediatrics and Internal ...
(Date:4/29/2016)... ... 2016 , ... Our bodies are bombarded daily by environmental and lifestyle factors ... stressors is to adopt a more healthful diet, but too many people think that ... Holistic Nutritionist and the creator of the Newport Beach Cleanse and 14-Day Eating Plan, ...
Breaking Medicine News(10 mins):