Navigation Links
Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV
Date:7/17/2008

- Once-daily TMC278, the third anti-HIV compound to be developed in Tibotec

virology portfolio -

YARDLEY, Pa., July 17 /PRNewswire/ -- Tibotec Pharmaceuticals Ltd. announced today that two major phase III efficacy trials examining TMC278, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI), in treatment-naive adults with HIV-1, are now recruiting patients. The global trials will compare the efficacy, safety and tolerability of TMC278 (25 mg) once daily oral tablet versus efavirenz (EFV), each coadministered with a background regimen of two nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs), in treatment-naive HIV-1-infected adults.

"Preliminary data have shown TMC278 to be active against HIV for patients who have not previously received treatment," Roger Pomerantz, MD, President of Tibotec Research and Development. "These phase III studies will provide important information on the safety and efficacy of this potential new treatment."

The first phase III, double-blind, randomized study, known as TMC278-C209 or ECHO (Efficacy Comparison in treatment-naive HIV-infected subjects Of TMC278 and EFV), will evaluate 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), will evaluate 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 will be conducted at more than 100 sites in over 20 countries, including the U.S., Canada and several countries in Latin America, among others, and will seek to enroll approximately 680 patients. To be eligible, patients must have a viral load greater than 5,000 copies/mL at screening and may not have taken any anti-HIV drugs prior to enrolling, as well as meet other screening criteria. The primary endpoint of the studies is to assess the proportion of patients with viral load < 50 copies/mL at week 48 on TMC278 vs. control (EFV). The studies will last for 104 weeks, which includes a four-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 U.S. Food and Drug Administration (FDA) for consideration for approval of TMC278.

TMC278 is the third anti-HIV compound to be developed by Tibotec Pharmaceuticals. Tibotec Pharmaceuticals 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 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.

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: Karen Manson

Mobile: +32 (479) 89 47 99


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

Related medicine technology :

1. AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
2. Maine Natural Health Company Conducts Dental Clinical Trial
3. Biodel Inc. Announces the Completion of Its Two Pivotal Trials and the Release of EASD Abstracts Containing Additional Interim Data From Its VIAject(TM) Program
4. Isolagen Completes Pivotal Efficacy Portion of Phase III Studies of Isolagen Therapy(TM) for Wrinkles
5. Terumo Heart Obtains IRB Approval from the University of Michigan to Initiate DuraHeart(TM) Left Ventricular Assist System U.S. Pivotal Trial
6. Pivotal Pulmonary Arterial Hypertension Study Published in The Lancet Concludes That Bosentan (Tracleer(R)) Demonstrates Benefits in Patients With Mildly Symptomatic WHO Functional Class II Disease
7. Victory Pharma, Inc. Reports MGX006 Enters Into Pivotal Development Program
8. European Enrollment Begins in Pivotal Phase 3 Trial of Novel Combination Medicine Developed by Cogentus Pharmaceuticals
9. Medivation Initiates Second Pivotal Phase 3 Trial of Dimebon(TM) in Patients With Alzheimers Disease
10. Nephros Completes Pivotal U.S. Clinical Trial for its Hemodiafiltration Products
11. Auxilium Pharmaceuticals, Inc. Announces XIAFLEX(TM) Meets Primary Endpoint With Statistical Significance (p<0.001) in CORD I Pivotal Phase III Study for Dupuytrens Contracture
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... , May 3, 2016 ... bekannt, dass sie einen entscheidenden Meilenstein durch ... Ein Aufruf zum Handeln, um Patientenresultate  bei ... trägt zu Fortschritten im Verständnis der Hepatischen ... ein Bewusstsein für Hepatische Enzephalopathie in der ...
(Date:5/2/2016)... , May 2, 2016 Leading Economies with Fastest ... 10.2 Côte d,Ivoire 8.6 Uzbekistan 8 Ireland 7.8 India 7.3, , ... BRICS nations , which comprises of Brazil , ... and South Africa , registered the fastest GDP growth ... in China , recession in Brazil ...
(Date:5/2/2016)... 2016  While nearly three-quarters of Americans (71%) are ... their health, only about half report taking any steps ... of a new survey announced today by Hologic (Nasdaq: ... National Osteoporosis Month, Hologic is raising awareness of this ... million Americans. Osteoporosis is a disease that ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... May 04, 2016 , ... ... Rider's research and development of DRACO broad-spectrum antiviral therapeutics. DRACOs have proven effective ... starts on May 3, 2016 at http://igg.me/at/EndTheVirus and runs for 60 ...
(Date:5/4/2016)... ... May 04, 2016 , ... ... and operators of commercial real estate proudly announced that its service-based charitable program, ... Team members portfolio-wide will continue Olshan Properties’ annual philanthropic tradition in 2016 ...
(Date:5/4/2016)... ... May 04, 2016 , ... Nike Rugby Camp's success is ... San Diego. Willis, founder of Elite Rugby Camps and current Nike Camp director, has ... year since 2009. , “I’m excited for our eighth summer here in San ...
(Date:5/4/2016)... (PRWEB) , ... May 04, 2016 , ... A new ... the world. The Duke Clinical Research Institute (DCRI) and analytics leader SAS will provide ... patient data collected by the Duke University Health System. , The DCRI and ...
(Date:5/4/2016)... ... May 04, 2016 , ... All-Star Insurance of Northeast TX ... people of their local community. The agency pledges to select a new beneficiary ... is to bring awareness to important local causes with fundraising and other support, ...
Breaking Medicine News(10 mins):