-- REALIZE is the first phase III study to evaluate a specifically
targeted antiviral therapy for hepatitis C (STAT-C) across a full
range of HCV-patients who failed prior treatment to current
standard of care, including null responders
MECHELEN, Belgium, Oct. 15 /PRNewswire-USNewswire/ -- Tibotec
BVBA announced today that it has begun enrolling patients in its
phase III clinical trial evaluating telaprevir, an
investigational hepatitis C virus protease inhibitor, in patients
who failed prior therapy with peginterferon (Peg-IFN) plus
ribavarin (RBV). The trial, known as REALIZE, will compare the
efficacy, safety and tolerability of telaprevir combined with
Peg-IFN plus RBV versus Peg-IFN and RBV alone, the current
standard of care. Investigators at U.S. trial centers have begun
screening patients for participation in the study, with global
centers expected to begin screening in the coming weeks.
Telaprevir is being co-developed by Vertex Pharmaceuticals
Incorporated and Tibotec. Tibotec, the sponsor of the REALIZE
trial, is managing the trial worldwide.
"We are excited about the ongoing development of telaprevir,
potentially the first direct antiviral for the treatment of HCV,
which may provide a new option for patients who have failed the
current standard of care," said Roger Pomerantz, MD, President,
Tibotec Research and Development. "We are committed to examining
the safety and efficacy of telaprevir through phase III trials
and look forward to working with health authorities with the goal
of making this therapy available to HCV infected patients."
The REALIZE trial (Re-treatment of Patients with Telaprevir-based
Regimen to Optimize Outcomes) is a phase III, randomized,
placebo-controlled double-blind study conducted over 72 weeks to
examine two regimens of 750 mg telaprevir every eight hours (with
and without a delayed start) combined with Peg-IFN and RBV versus
Peg-IFN and RBV alone. To be eligible for the study, patients
must belong to one of the following three groups:
1. Null responders (defined as patients who achieved <2 log
reduction in HCV RNA at week 12 of prior therapy);
2. Partial responders (defined as patients who achieved at least
a 2 log reduction at week 12, but never achieved undetectable HCV
RNA during prior therapy); and
3. Relapsers (defined as patients who had undetectable HCV RNA at
the completion of at least 42 weeks of prior treatment, but
relapsed during follow-up).
The trial will enroll approximately 650 HCV patients at more than
30 centers in the U.S., 50 centers in Europe and 20 centers in
the rest of the world. The study will include 300 null- and
partial-responder patients and 350 patients with viral relapse.
REALIZE is the first phase III study to evaluate a direct
antiviral (or STAT-C) treatment for HCV in null responder
The primary endpoint of the REALIZE study is sustained virologic
response (SVR), defined as undetectable HCV RNA (<10 IU/mL) 24
weeks after the completion of treatment. Patients enrolled in
this study will be randomized to three treatment arms:
1. Telaprevir dosed at 750 mg every eight hours (q8h) for 12
weeks in combination with standard doses of Peg-IFN and RBV,
followed by 36 weeks of treatment with Peg-IFN and RBV alone;
2. Delayed start arm, comprised of four weeks of treatment with
Peg-IFN and RBV, followed by telaprevir dosed at 750 mg q8h for
12 weeks in combination with standard doses of Peg-IFN and RBV,
followed by another 32 weeks of Peg-IFN and RBV alone; or
3. A control arm with standard doses of Peg-IFN and RBV dosed for
Patients in all treatment arms will be followed for 24 weeks
after completion of treatment to assess SVR.
For additional information on inclusion and exclusion criteria
for this study, please see www.clinicaltrials.gov.
The REALIZE phase III study in treatment failure patients is part
of a comprehensive clinical development program for telaprevir.
Vertex is managing the ADVANCE phase III trial in treatment-naive
Tibotec has the right to develop and commercialize telaprevir in
Europe, South America, the Middle East, Africa, India, Australia
and New Zealand. Vertex will commercialize telaprevir in the
U.S., Canada and Mexico.
As a global virology leader committed to patient care, Tibotec
uses innovative science and expertise to research, develop,
manufacture and market drugs of unmet need. Tibotec is dedicated
to building a portfolio of novel antiviral therapies to address
the significant unmet needs of patients with chronic hepatitis C.
In addition to its partnership with Vertex to develop and
commercialize telaprevir, Tibotec is currently developing with
partner Medivir a second potential treatment for HCV which is in
early stage trials. Through the application of its deep
understanding of virology and viral resistance, Tibotec has
become an established leader in HIV/AIDS, having developed and
made available two antiretroviral agents for the treatment of
HIV. Tibotec continues its commitment to developing novel
therapies through a robust research and development program,
which includes a third anti-HIV treatment as well as a potential
treatment for tuberculosis.
About Tibotec BVBA
Tibotec BVBA is a global pharmaceutical and research development
company. The Company's main research and development facilities
are in Mechelen, Belgium with offices in Yardley, Pa. and Cork,
Ireland. Tibotec is dedicated to the discovery and development of
innovative HIV/AIDS and hepatitis C drugs, and anti-infectives
for diseases of high unmet medical need.
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 BVBA'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 31,
2006. Copies of this Form 10-K, as well as subsequent filings,
are available online at www.sec.gov, www.jnj.com or on request
from Tibotec BVBA or Johnson & Johnson. Tibotec BVBA does not
undertake to update any forward-looking statements as a result of
new information or future events or developments.
Tibotec is a member of the Johnson & Johnson family of companies.
Source: Tibotec BVBA
CONTACT: Karen Manson of Tibotec BVBA, Mobile: +32 (479) 89 47 99
Web Site: http://www.clinicaltrials.gov/