QLT announces 12-month results from Novartis sponsored MONT BLANC study evaluating standard-fluence Visudyne(R) combination therapy



    VANCOUVER, June 15 /CNW/ - QLT Inc. (NASDAQ:   QLTI; TSX: QLT) today
announced that twelve-month primary analysis results from the Novartis
sponsored Phase II MONT BLANC study were presented on June 14, 2009 during the
17th Congress of the European Society of Ophthalmology in Amsterdam, the
Netherlands. MONT BLANC is the European study of the Novartis sponsored SUMMIT
clinical trial program which investigates the efficacy and safety of combining
Visudyne(R) (Novartis Pharma AG) and Lucentis(R) (Novartis Pharma AG,
Genentech Inc.). SUMMIT also includes the DENALI study in the US and Canada
and the EVEREST study in Asia. MONT BLANC is a 24-month randomized,
double-masked, multicenter trial in patients with subfoveal choroidal
neovascularization secondary to age-related macular degeneration. The purpose
of the study is to evaluate whether Visudyne combined with Lucentis is not
inferior to Lucentis monotherapy with respect to the mean change from baseline
in visual acuity (VA) and to evaluate the proportion of patients with a
treatment-free interval of at least three months duration after Month 2. At
the Month 12 examination, mean VA in the Visudyne combination therapy group
improved 2.5 letters from baseline compared with a 4.4 letter improvement in
the Lucentis monotherapy group. In the combination therapy group, 96% of
patients had a three-month treatment-free interval, compared with 92% in the
Lucentis monotherapy group.
    Twelve-month results of the MONT BLANC study show that combining
standard-fluence Visudyne with Lucentis 0.5 mg can deliver VA improvements
that are non-inferior to a Lucentis monotherapy regimen with three Lucentis
loading doses followed by injections on a monthly as-needed basis
(non-inferiority margin of 7 letters). There was no significant difference
between the combination and monotherapy groups with regard to proportion of
patients with a treatment-free interval of at least three months duration
after Month 2. There were no unexpected safety findings, and adverse event
incidence was similar between treatment groups.
    Additional post hoc analysis showed that 85% of patients in the Visudyne
combination therapy group, compared with 72% in the Lucentis monotherapy
group, had a treatment-free interval of at least four months duration after
Month 2. Median time to first retreatment after month 2 was extended by ~1
month in the combination group (month 6) versus the monotherapy group (month
5). Patients in the combination group received, on average, a total of 4.8
ranibizumab injections compared with 5.1 in the monotherapy group and a total
of 1.7 Visudyne treatments compared with 1.9 sham treatments in the
monotherapy arm. Results are based on ITT analyses (with LOCF); per-protocol
analyses yielded similar results. Overall, only 15 patients discontinued the
study before Month 12 (6%).
    "MONT BLANC provided the first data within the SUMMIT clinical trial
program and showed that patients treated with Visudyne combination therapy had
non-inferior visual acuity to patients treated with Lucentis monotherapy,"
said Bob Butchofsky, Chief Executive Officer of QLT Inc. "The results from
DENALI, which includes a Visudyne reduced fluence arm, and EVEREST, which
studies combination therapy in polypoidal choroidal vasculopathy, may add to
the knowledge about the potential benefits of combining Visudyne and
Lucentis."

    About MONT BLANC Phase II Study

    The MONT BLANC study is a Phase II, multicenter, randomized,
double-masked study comparing standard-fluence Visudyne-Lucentis combination
therapy to Lucentis monotherapy in 255 subjects with choroidal
neovascularization (CNV) secondary to wet age-related macular degeneration
(wet AMD). Subjects were randomly assigned to one of two treatment groups:
Standard-fluence Visudyne (600 mW/cm2 for 83 seconds to deliver 50 J/cm2)
followed by same day intravitreal Lucentis (0.5 mg), or Lucentis monotherapy
(0.5 mg). The Lucentis monotherapy group received sham Visudyne treatment to
maintain masking. Standard-fluence Visudyne (or sham) was administered at
baseline and then as needed at intervals of at least three months if required
based on predefined re-treatment criteria. Lucentis was administered to both
treatment groups with three loading doses followed by monthly treatment if
required based on predefined re-treatment criteria. Patients were evaluated
for VA, anatomical changes and safety at every monthly visit, and the need for
retreatment was assessed at monthly visits from Month 3 to Month 11.
Re-treatment was based on assessment of central retinal thickness (CRT)
(increase of greater than or equal to 100 (micro)m), presence of subretinal
fluid, as assessed by optical coherence tomography (OCT), presence of new
subretinal hemorrhage as assessed by ophthalmoscopic examination, presence of
CNV leakage as assessed by fluorescein angiography (FA) and decreases in VA of
greater than 5 letters as assessed by an Early Treatment Diabetic Retinopathy
Study (ETDRS) chart. As-needed Lucentis after three loading doses is a
standard regimen in Europe, but not in the US, and combination therapy for AMD
is not approved for marketing by regulatory agencies. The study duration is 24
months with a planned primary analysis when all subjects completed 12 months
of follow-up. At baseline, mean VA letter score was 54 to 55 across treatment
groups.

    About Visudyne

    Visudyne therapy is a two-step procedure involving the intravenous
administration of the drug into the patient's arm. A non-thermal laser light
is then shone into the patient's eye to activate the drug. This produces a
reaction that closes the abnormal leaky vessels, resulting in a stabilization
of the corresponding vision loss.
    Visudyne is approved worldwide for the treatment of a form of wet AMD,
the leading cause of legal blindness in people over the age of 50, and has
been used in more than two million treatments worldwide. Visudyne is
commercially available in more than 80 countries for the treatment of
predominantly classic subfoveal CNV. In addition, over 60 countries have
approved Visudyne to treat one or more other macular neovascular conditions
such as minimally classic and occult with no classic AMD lesions, pathologic
myopia and presumed ocular histoplasmosis.
    Visudyne is generally well tolerated and has a well established safety
profile. The most commonly reported side effects include injection site
reactions and visual disturbances. In addition, some patients experienced back
pain, usually during the infusion. Using the approved light dose of 50J/cm2
between 1% and 5% of patients experienced a substantial decrease in vision in
the first 7 days with partial recovery in some patients. Recent studies
suggest that halving the light dose/fluence by halving the fluence rate may
lower the incidence of visual disturbances with possibly better visual
outcomes than the standard light dose used in this study. After treatment,
patients should avoid direct sunlight for five days to prevent sunburn. People
with porphyria should not be treated with Visudyne.

    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
field of ophthalmology. In addition, we utilize three unique technology
platforms, photodynamic therapy, Atrigel(R) and punctal plugs with drugs, to
create products such as Visudyne(R) and Eligard(R) and future product
opportunities. For more information, visit our website at www.qltinc.com.

    
    Atrigel is a registered trademark of QLT USA, Inc.
    Lucentis is a registered trademark of Genentech, Inc.
    Visudyne is a registered trademark of Novartis AG.
    Eligard is a registered trademark of Sanofi-Synthelabo Inc.
    QLT Plug Delivery, Inc. is a wholly-owned subsidiary of QLT 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."

    Forward-Looking Statements

    Certain statements in this press release 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. Forward looking statements
include, but are not limited to: the results of clinical studies may not
necessarily result in increased use of Visudyne; our expectations for timing
to receive and release further data from clinical studies; any future
expectations concerning Visudyne-Lucentis combination therapy; and statements
which contain language such as: "assuming," "prospects," "future," "projects,"
"believes," "expects" and "outlook." 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. Many such risks, uncertainties and other
factors are taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the following:
uncertainties relating to the timing and results of the clinical development
and commercialization of our products and technologies (including
Visudyne-Lucentis combination therapy and our punctal plug technology) and the
associated costs of these programs; the timing, expense and uncertainty
associated with the regulatory approval process for products; uncertainties
regarding the impact of competitive products and pricing; risks and
uncertainties associated with the safety and effectiveness of our technology;
risks and uncertainties related to the scope, validity, and enforceability of
our intellectual property rights and the impact of patents and other
intellectual property of third parties; and general economic conditions and
other factors 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:

For further information: QLT Inc.: Vancouver, Canada, Karen Peterson,
Telephone: (604) 707-7000 or 1-800-663-5486, Fax: (604) 707-7001; The Trout
Group Investor Relations Contact: New York, USA, Christine Yang, Telephone:
(646) 378-2929 or Marcy Nanus, Telephone: (646) 378-2927

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