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:1/18/2017)... -- Aprima Medical Software, a leading provider of innovative ... revenue cycle management (RCM) solutions for medical practices, ... Healthcare Data Solutions (HDS) of Coral Cables, FL. ... full support for HDS,s customers, which include approximately ... states. Financial terms were not disclosed. ...
(Date:1/18/2017)... JOSE, Calif. , Jan. 18, 2017  Adaptive Sound ... announced today a new partnership with Hyatt Place Nashville/Downtown ... by providing ASTI LectroFan sleep therapy machines in over ... one of the most important parts of having a ... , general manager of Hyatt Place Nashville/Downtown. "We,re pleased ...
(Date:1/18/2017)... PUNE, India , January 18, 2017 According to ... Type and by Application: Global Opportunity Analysis and Industry Forecast, 2014 - 2022," ... expected to reach $1,127 million by 2022, growing at a CAGR of 8.26% ... share, in terms of revenue. Continue Reading ... ...
Breaking Medicine Technology:
(Date:1/18/2017)... ... 2017 , ... The VA Maryland Health Care System and ... project focused on multiple sclerosis (MS). Led by Christopher M. Jewell, PhD, an ... disease without compromising normal immune function that often occurs during autoimmune diseases. Ultimately ...
(Date:1/18/2017)... Cranbury, NJ (PRWEB) , ... ... ... Times®, the specialty pharmacy industry‚Äôs leading journal and most-read publication among specialty ... Vanderbilt University Medical Center through its Strategic Alliance Partnership (SAP) program, announced ...
(Date:1/18/2017)... ... January 18, 2017 , ... A Palm Beach doctor ... Smile Train, an international charity that provides free surgery to poor children suffering from ... in the past I have run to support the efforts of the American Heart ...
(Date:1/18/2017)... , ... January 18, 2017 , ... The Portee Insurance ... families and business owners in central Maryland and the DC region, is inaugurating a ... kills 787,000 people nationally every year, making it the #1 killer in America. However, ...
(Date:1/18/2017)... ... , ... At Hallmark Nameplate, their commitment to quality is what sets them ... 13485. This certification is another way they are making constant strides to provide all ... need. , The ISO 13485 Certification is a major accomplishment for Hallmark Nameplate and ...
Breaking Medicine News(10 mins):