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Biotech / Medical : Biotech failure, 2002 -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (123)	5/12/2003 4:32:55 PM
From: Icebrg	Read Replies (1) \| Respond to of 130

QLT discontinues tariquidar phase III non-small cell lung cancer trials following planned interim analysis by the Independent Data Safety Monitoring Committee Monday May 12, 4:00 pm ET QLT Intends to Carefully Review the Data in Order to Plan for Next Steps for Tariquidar VANCOUVER, May 12 /PRNewswire-FirstCall/ - QLT Inc. (NASDAQ: QLTI - News; TSX: QLT - News) 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 - News; London Stock Exchange: XEN - News) for the development and marketing rights in North America in August 2001.