QLT halts tariquidar study enrolment for safety review
QLT Inc QLT
Shares issued 68,229,615 Feb 20 close $13.66
Fri 21 Feb 2003 News Release
Ms. Therese Hayes reports
QLT TEMPORARILY SUSPENDS NEW PATIENT ACCRUAL IN PHASE III STU ...
Enrolment of additional patients in QLT's continuing 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
Enrolment 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
1,000 patients were to be enrolled in two randomized, multicentred,
placebo-controlled trials using tariquidar in combination with two of the
most commonly used chemotherapy regimens (paclitaxel plus carboplatin or
vinorelbine alone).
The trials, being conducted at roughly 100 centres 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 multidrug 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
for the development and marketing rights in North America in August, 2001.
Conference call information
QLT will hold an analyst and institutional investor conference call to
discuss this item on Friday, Feb. 21 at 8:30 a.m. ET (5:30 a.m. PT). The
call will be broadcast live via the Internet on the company's Web site. A
replay of the call will be available via the Internet and also via
telephone at (416) 695-5800, access code 1381104.
WARNING: The company relies upon litigation protection for
"forward-looking" statements.
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