EXHIBIT 99.1
[QLT Inc. Letterhead]
n e w s r e l e a s e
QLT TEMPORARILY SUSPENDS NEW PATIENT ACCRUAL IN PHASE III STUDIES
OF TARIQUIDAR PENDING PLANNED INTERIM ANALYSIS
Data from the Previously Planned Interim Analysis to be Available
by the End of the Second Quarter
FOR IMMEDIATE RELEASE FEBRUARY 21, 2003
VANCOUVER, CANADA--QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced today that
enrollment of additional patients in its ongoing phase III studies of tariquidar
in non-small cell lung cancer patients is being suspended for approximately
three months pending the completion of the planned interim safety and efficacy
analysis by an Independent Data and Safety Monitoring Committee (DSMC).
The DSMC has recommended that accrual to the trials be temporarily halted until
all patients currently enrolled have been followed for a minimum of three months
and that the patients should continue to be treated and followed according to
the protocol. The committee also stated that all data should remain blinded and
that the intention of this halt in accrual is to permit, for those patients
already entered, acquisition and review of additional data on safety and
efficacy. The DSMC concluded that the recommendations above "provided the best
opportunity for these trials to remain intact and to serve, in their entirety as
pivotal registration trials for regulatory purposes."
The DSMC is an independent panel of experts who are not participating in the
studies. The primary responsibility of the DSMC is to oversee the studies and
safeguard the interests of current and future participants in these trials. The
DSMC has not reviewed any efficacy data for the trials. Accrual in the two Phase
III studies had already reached the threshold number of patients required for
the three-month interim analysis. The DSMC felt that a review of the patients
enrolled to date would be sufficient "to permit an assessment of differences in
response rates between the two arms of the trial, and to provide information on
short to mid term differences in survival" and to make an initial assessment of
therapeutic benefit to potential risk.
ABOUT TARIQUIDAR
Enrollment began in June 2002, for the two phase III clinical trials using
tariquidar as an adjunctive treatment in combination with first-line
chemotherapy for non-small cell lung cancer (NSCLC) patients. Approximately 1000
patients were to be enrolled in two randomized, multi-centered,
placebo-controlled trials using tariquidar in combination with two of the most
commonly used chemotherapy regimens (paclitaxel plus carboplatin or vinorelbine
alone).
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The trials, being conducted at roughly 100 centers located throughout North
America and Europe, are designed to demonstrate the ability of tariquidar to
enhance the efficacy of chemotherapy agents. This occurs by preventing or
overcoming resistance due to overexpression of P-glycoprotein (P-gp), a membrane
protein that pumps chemotherapeutic agents out of cancer cells. Overall survival
is the primary end-point in both trials. The U.S. Food and Drug Administration
(FDA) has granted fast track review status to tariquidar for the treatment of
multi-drug resistance in first-line treatment of NSCLC patients.
Upon successful completion of the phase III program, it is anticipated that QLT
will file for approval of tariquidar in North America for use in combination
with first-line chemotherapy in advanced NSCLC in 2005. NSCLC is the first of
several indications for which tariquidar will be investigated. QLT is also
continuing its phase II trial with tariquidar in patients with refractory breast
cancer at the University of Texas MD Anderson Cancer Center. Tariquidar was
in-licensed from Xenova Group plc (NASDAQ NM: XNVA; London Stock Exchange: XEN)
for the development and marketing rights in North America in August 2001.
ABOUT QLT
QLT Inc. is a global biopharmaceutical company dedicated to the discovery,
development, and commercialization of innovative therapies to treat cancer, eye
diseases and immune disorders. Combining expertise in ophthalmology, oncology
and photodynamic therapy, QLT has commercialized two products to date, including
Visudyne(R) therapy, which is the most successfully launched ophthalmology
product ever. For more information, visit our web site at www.qltinc.com
CONFERENCE CALL INFORMATION
QLT Inc. will hold an analyst and institutional investor conference call to
discuss this item on Friday, February 21 at 8:30 a.m. EST (5:30 a.m. PST). The
call will be broadcast live via the Internet at www.qltinc.com. A replay of the
call will be available via the Internet and also via telephone at (416)
695-5800, access code 1381104.
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QLT Inc.: Media Contact:
- -------- -------------
Therese Hayes Tamara Hicks
Telephone: 604-707-7000 or 1-800-663-5486 Telephone: 604-788-5144
Fax: 604-707-7001
Visudyne(R)is a trade mark of Novartis AG
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."
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Certain statements in this press release constitute "forward-looking statements"
of QLT within the meaning of the Private Securities Litigation Reform Act of
1995, which involve known and unknown risks, uncertainties and other factors
that may cause our actual results to be materially different from any future
results, performance or achievements expressed or implied by such statements.
Forward-looking statements include, but are not limited to, those with respect
to: the planned continuation of the trial for a three month period, when the
interim analysis by the DSMC is scheduled to occur, the anticipation of future
recommendations of the DSMC, the potential of the trial to serve as a pivotal
trial for regulatory purposes, the anticipated filing of regulatory approval and
the plan to investigate tariquidar in other indications. These statements are
only predictions and actual events or results may differ materially. Factors
that could cause such actual events or results expressed or implied by such
forward-looking statements to differ materially from any future results
expressed or implied by such statements include, but are not limited to:,
clinical development programs may not be successful, and other factors described
in detail in QLT's Annual Information Form 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 our current expectations and QLT is not obligated to update such information
to reflect later events or developments.
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