Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : QLT PhotoTherapeutics (QLTI) -- Ignore unavailable to you. Want to Upgrade?

To: Davy Crockett who wrote (1264)	10/3/2002 8:09:38 AM
From: Al Collard	Respond to of 1321

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."