CNW
VANCOUVER, May 5 /CNW/ - QLT Inc. (NASDAQ: QLTI; TSX: QLT) today
announced it has completed enrolling 160 patients in the Company's Phase II
RADICAL trial to determine if combination therapy with Visudyne(R) reduces
retreatment rates compared with an anti-VEGF antibody while maintaining
similar vision outcomes and an acceptable safety profile.
"The completion of enrollment in the RADICAL trial signifies that we are
one step closer to our goal of having the use of Visudyne followed by
Lucentis(R), with or without an anti-inflammatory agent, potentially added to
the product's label," said Bob Butchofsky, President and Chief Executive
Officer. "We look forward to reporting interim results in the fourth quarter
of 2008 and top-line results in the first half of 2009."
The RADICAL trial is a Phase II, multicenter, randomized, single-masked
study comparing reduced-fluence Visudyne-Lucentis combination therapies and
Lucentis monotherapy in subjects with choroidal neovascularization (CNV)
secondary to age-related macular degeneration (AMD). Patients are randomized
to receive one of four treatments: Reduced fluence Visudyne followed by
Lucentis, Reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple
therapy, Very low-fluence Visudyne followed by Lucentis-Dexamethasone triple
therapy, or Lucentis monotherapy. The duration of the trial is 24 months.
About QLT
QLT Inc. is a global biopharmaceutical company dedicated to the
discovery, development and commercialization of innovative therapies. Our
research and development efforts are focused on pharmaceutical products in the
fields of ophthalmology and dermatology. In addition, we utilize three unique
technology platforms, photodynamic therapy, Atrigel(R) and punctal plugs with
drugs, to create products such as Visudyne and Eligard(R) and future product
opportunities. For more information, visit our web site at www.qltinc.com.
Visudyne (verteporfin for injection) therapy is indicated for the
treatment of patients with predominantly classic subfoveal choroidal
neovascularization due to age-related macular degeneration, pathologic myopia
or presumed ocular histoplasmosis.
Lucentis is indicated for the treatment of patients with neovascular
(wet) agerelated macular degeneration.
Atrigel is a registered trademark of QLT USA, Inc.
Visudyne is a registered trademark of Novartis AG.
Eligard is a registered trademark of Sanofi-aventis.
Lucentis is a registered trademark of Genentech, Inc.
QLT Inc. is listed on The NASDAQ Stock Market under the trading symbol
"QLTI" and on The Toronto Stock Exchange under the trading symbol "QLT."
Certain statements in this press release that are not historical facts
constitute "forward-looking statements" of QLT within the meaning of the
Private Securities Litigation Reform Act of 1995 and constitute
"forward-looking information" within the meaning of applicable Canadian
securities laws. Such statements include, but are not limited to: our
statements related to our goal of Visudyne followed by Lucentis potentially
added to the product's label and our statements related to our potential
reporting of Visudyne combination therapy study interim results in the fourth
quarter of 2008 and top-line results in the first half of 2009 and statements
which contain language such as "expects," "will", "plans," "potential,"
"intends," "believes" and similar expressions that do not relate to historical
matters. Forward-looking statements are predictions only which involve known
and unknown risks, uncertainties and other factors that may cause actual
results to be materially different from those expressed in such statements.
Factors that could cause actual events or results to differ materially
include, but are not limited to: risks and uncertainties relating to the
timing, expense and outcome of clinical trials; the timing, expense and
uncertainty associated with the regulatory approval process for products; the
timing and impact of existing competitive products and/or new products
launched by competitors and the level of physician acceptance of Visudyne in
combination with other agents); and other factors, including those described
in detail in QLT's Annual Report on Form 10-K, quarterly reports on Form 10-Q
and other filings with the U.S. Securities and Exchange Commission and
Canadian securities regulatory authorities. Forward-looking statements are
based on the current expectations of QLT and QLT does not assume any
obligation to update such information to reflect later events or developments
except as required by law.
For further information: QLT Inc.: Vancouver, Canada, Therese Hayes,
Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604) 707-7001; The Trout
Group: New York, USA, Brandon Lewis, Telephone: (646) 378-2915; or Marcy
Strickler, Telephone: (646) 378-2927