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QLT Intends to Carefully Review the Data in Order to Plan for Next Steps for Tariquidar
FOR IMMEDIATE RELEASE MAY 12, 2003
VANCOUVER, CANADA-QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced today that it
will stop its current Phase III tariquidar trials in non-small cell lung cancer. This decision was
made by QLT following a recommendation by the Independent Data Safety Monitoring
Committee (DSMC) who completed the unblinded review of the data for both ongoing trials in
this indication.
Members of the Company's clinical development team will now be unblinded so that they have
opportunity to review all of the data and can make informed decisions about plans for future
development of tariquidar. Data from the 304 patients already enrolled in these studies represents
the largest collection of efficacy and safety data from randomized, placebo-controlled studies of
a third generation P-gp inhibitor and will offer valuable insight into the potential for tariquidar in
this or other indications. It is QLT's intention to exploit the value of this database and make
planning decisions for tariquidar after a thorough analysis of such data.
QLT expects that there will be savings associated with stopping the trial, and will update what
that potential impact might be after a careful review of the interim analysis.
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.
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, multicentered,
placebo-controlled trials using tariquidar in combination with two of the most
commonly used chemotherapy regimens (paclitaxel plus carboplatin or vinorelbine alone).
The trials were conducted at roughly 100 centers located throughout North America and Europe,
and were 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.
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.
QLT Inc. (NASDAQ: QLTI; TSX: QLT) is a global pharmaceutical company specializing in the
discovery, development and commercialization of innovative therapies to treat cancer, eye
diseases and niche areas for which treatments can be marketed by a specialty sales force.
Combining expertise in ophthalmology, oncology and photodynamic therapy, QLT has
commercialized two products to date, including Visudyne 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
Monday, May 12 at 5:00 p.m. EST (2:00 p.m. PST) via telephone at (416) 695-5806. 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 1422099.
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QLT Inc.:
Vancouver, Canada
Therese Hayes
Telephone: 604-707-7000 or 1-800-663-5486
Fax: 604-707-7001
Media Contact:
Anna Wright (James Hoggan)
Telephone:
604-742-4261
Visudyne® 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.”
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 potential positive impact on QLT’s EPS and the possibility that tariquidar could be developed further. 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. |
