One of the ways cancer cells defeat the drugs we use to defeat cancer cells (in bold),...
QLT Receives FDA fast track status for Tariquidar
VANCOUVER, Oct. 3 /CNW/ - QLT Inc. (NASDAQ: QLTI; TSE: QLT) announced
today that 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 non-small cell lung cancer (NSCLC) patients.
Under the FDA Modernization Act of 1997, designation as a Fast Track
Product means that the FDA will facilitate the development and expedite the
review of a new drug that is intended for the treatment of a serious or a life-
threatening condition and demonstrates the potential of a drug candidate to
address unmet medical needs for such a condition.
QLT is enrolling patients into its phase III clinical program using
tariquidar as an adjunctive treatment in combination with first-line
chemotherapy for NSCLC patients. The Company in-licensed tariquidar from
Xenova Group plc (NASDAQ NM: XNVA; London Stock Exchange: XEN) for the
development and marketing rights in North America in August 2001.
"We're very enthusiastic about the potential for tariquidar and the FDA's
decision to grant fast track status," said Paul Hastings, president and CEO of
QLT Inc. "Tariquidar is the second major driver in QLT's business and we
believe that it has the potential to be an even larger product than
Visudyne(R)."
Tariquidar is being studied in NSCLC through a randomized and controlled
phase III clinical program with survival as the primary endpoint. It is
anticipated that approximately 1000 patients will participate in the currently
designed phase III clinical trial program at roughly 100 centers throughout
North America and Europe. An interim analysis is planned for mid-2003.
Additionally, a phase IIb multi-centered trial for patients with refractory
breast cancer is being conducted in the U.S.
It is anticipated that, on successful completion of the phase III
program, QLT will file for approval of tariquidar in North America for use in
combination with first-line chemotherapy in advanced NSCLC by the end of 2005.
Background Information
In the United States, a total of 169,500 new cases of lung cancer were
estimated for 2001, accounting for 13% of cancer diagnoses. Lung cancer is the
leading cause of cancer-related death in United States, accounting for over
30% of cancer deaths in men and 25% in women. NSCLC accounts for approximately
80% of all lung cancer cases.
One of the major barriers to successful cancer treatment is the
development of resistance by cancer cells to several drugs used in
chemotherapy - a condition referred to as multi-drug resistance (MDR).
Tariquidar targets the most common form of this drug resistance through the
inhibition of P-glycoprotein (P-gp), a membrane based "pump" that acts to
expel the chemotherapy drug from the tumor cell, thereby preventing drug
accumulation and inhibiting efficacy. Accumulating evidence indicates that the
inhibition of P-gp can improve chemotherapeutic outcomes in several types of
cancer.
MDR is a problem for many of the most common cancers and involves some of
the most widely administered chemotherapeutic agents. According to IMS
Health's National Disease and Therapeutic Index (NDTI), in 2001, these drugs
accounted for over 1.6 million office-based administrations by medical
oncologists in the U.S.
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, you are invited to visit our web site at
www.qltinc.com.
Xenova Group plc's product pipeline focuses principally on the
therapeutic areas of cancer and immune system disorders. Xenova currently has
a broad pipeline of eight programs in clinical development. The Group has a
well-established track record in the identification, development and
partnering of innovative products and technologies and has partnerships with
major pharmaceutical companies including Lilly, Pfizer, Celltech, Genentech,
QLT and Millennium Pharmaceuticals.
For further information about Xenova and its products please visit the
Xenova web site at www.xenova.co.uk
Visudyne(R) is a trademark 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 efficacy of the drug tariquidar and its
potential to become a successful commercial product. 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: we might
experience inadequate patient enrolment for the clinical trials; results from
the clinical trials are uncertain and might be unfavorable; our development
efforts might not yield a marketable product, we might experience impediments
in the commercialization of the product, and many other factors described in
detail in QLT's Annual Information Form on Form 10-K, forthcoming quarterly
reports on Form 10-Q and other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements are based on our current expectations
and QLT is not obligated to update such information to reflect later events or
developments. |
