Bummer!,...
QLT discontinues tariquidar Phase III non-small cell lung cancer trials following planned interim analysis by the Independent Data Safety Monitoring Committee
QLT Intends to Carefully Review the Data in Order to Plan for Next Steps
for Tariquidar
VANCOUVER, May 12 /CNW/ - 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, multi-centered, 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.
Visudyne(R) is a trade mark of Novartis AG |
