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To: DaveAu who wrote (4083)	4/13/2000 2:07:00 AM
From: Cal Gary	Respond to of 14101

OT: QLT pleased by approval of Visudyne therapy >> I'll be watching closely tomorrow to see how the FDA news pans out for QLT. Especially during Imploding tech and biotech markets. What gonna happen, buy on surprise news or sell on news?? Perhaps premonition of our beloved DMX. Any guesses before market opens?? QLT PhotoTherapeutics Inc QLT Shares issued 64,419,265 Apr 12 close $83.00 Wed 12 Apr 2000 News Release Ms. Elayne Wandler reports The U.S. Food and Drug Administration (FDA) has approved Visudyne (verteporfin for injection) therapy for the treatment of the wet form of age-related macular degeneration (AMD), the leading cause of blindness in people over the age of 50 in the western world. Specifically, the FDA approved Visudyne therapy for the treatment of AMD in patients with predominantly classic subfoveal choroidal neovascularization (CNV). Medical experts estimate that of the 500,000 new patients that develop wet AMD every year around the world, 40 to 60 per cent will develop predominantly classic lesions during the progression of their disease. Patients with this condition lose their ability to read, drive and recognize faces in as little as two months to three years. "The approval of Visudyne therapy to treat AMD is a landmark event within the field of ophthalmology. As the first approved drug therapy for this devastating condition, Visudyne provides new hope to many of the 200,000 Americans who lose their vision from wet AMD every year," said Luzi von Bidder, president of CIBA Vision's worldwide ophthalmics business unit. "This therapy will be available to eye care professionals and their patients across the country within 24 hours." "This is a proud day for all QLT and CIBA Vision employees," said Dr. Julia Levy, president and chief executive officer of QLT. "We have worked toward this day since we treated the first AMD patient with Visudyne therapy in clinical trials just five years ago. The relatively short development time from discovery to market illustrates not only QLT's capabilities but the importance of having a committed partner like CIBA Vision." The approval was based on 12-month data from two 24-month randomized, double-masked, placebo-controlled Phase III trials known as the TAP (Treatment of AMD with Photodynamic therapy) Investigation. The results of the TAP Investigation were published in the October, 1999, issue of Archives of Ophthalmology, a leading international medical journal. The primary finding of these trials showed that in 243 patients with predominantly classic CNV, vision remained stable or improved in 67 per cent of patients treated with Visudyne therapy compared with 39 per cent of patients on placebo (p<0.001). Top-line data has recently been released showing that the beneficial effect and the favorable safety profile of Visudyne therapy observed at the 12-month time point has been maintained out to two years with fewer treatments required in the second year. Visudyne therapy is currently approved and commercially available in Switzerland and Malta. Regulatory applications are pending in the European Union, Canada, Norway, Iceland, Australia, New Zealand, Brazil, Argentina and India, among others. While regulatory reviews are ongoing, Visudyne is currently being made available under certain expanded access programs in more than 25 countries. "With this effective new therapy now available in the United States, it is increasingly important to heighten the awareness of this condition among the general public," said Robert Gray, chief executive officer of the Foundation Fighting Blindness. "Despite the high prevalence of AMD, according to a recent study, only 30 per cent of American adults are familiar with the condition. "We encourage everyone over the age of 50 to see their eye care professional once a year for a routine check up," he added. Patients and physicians seeking additional information may view the Visudyne web site at www.visudyne.com or call 1-800-821-2450 within North America. WARNING: The company relies on litigation protection for "forward-looking" statements. (c) Copyright 2000 Canjex Publishing Ltd. canada-stockwatch.com

To: DaveAu who wrote (4083)	4/13/2000 7:25:00 AM
From: Mark Bartlett	Read Replies (2) \| Respond to of 14101

Bluejay, There are a couple of things I want to get clarified too and your query is one of them. I believe I know what they mean, but before I comment, I want to get clarified first. This study is still double-blinded, so it is impossible to assign SAE events to any one group -- as far as we know they may have all been in the placebo, the WF10 group, or in a weighted or equal combination in both groups. The fact that the trial remains ongoing suggests the SAEs are at least equal to, or less than what one would statistically expect, if no one were getting the drug. My gut feeling is the researchers are seeing some positive things happening in some of the study participants ( either stabilization or improvement) and deterioration in others. If the "deterioration" group are following a pattern typical for late-stage AIDS patients, then by logical reasoning one could imply that those who are improving, are improving because of WF10. MB