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Biotech / Medical : XILLIX FDA APPROVED -- Ignore unavailable to you. Want to Upgrade?

To: Brad who wrote (338)	12/23/1998 5:04:00 PM
From: Garry K.	Read Replies (1) \| Respond to of 572

QLTs Photofrin has received additional marketing approval from the FDA. This can possibly have an indirect benefit to companies like Xillix, as a treatment for lung cancer bodes well for early diagnostic techniques. FDA clears QLT's PHOTOFRIN(R) as a palliative treatment for late-stage lung cancer VANCOUVER, Dec. 23 /CNW/ - QLT PhotoTherapeutics Inc. announced today that the U.S. Food and Drug Administration (FDA) has given marketing clearance to QLT's PHOTOFRIN(R) (porfimer sodium) for Injection to include the palliative treatment of late-stage lung cancer. Specifically, the federal regulatory agency cleared PHOTOFRIN(R) for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer. The FDA ruling, which follows a unanimous recommendation in early September by an FDA advisory panel, allows Sanofi Pharmaceuticals, Inc. - QLT's U.S. marketing and distribution partner - to expand its current marketing efforts to a broader physician population. A U.S. commercial launch by Sanofi is expected in the first quarter of 1999. ''Today's FDA decision-the second U.S. regulatory approval for PHOTOFRIN(R) this year, and the third since 1995-reflects our steady evolution toward commercial success,'' said Dr. Julia Levy, QLT's President and CEO. ''It also marks another building block in QLT's campaign to widen the availability of photodynamic therapy to patients who can benefit from our innovative technology, and to expand our oncology franchise in the U.S.'' Sanofi is currently marketing PHOTOFRIN(R) in the U.S. as a potentially-curative treatment for certain types of early-stage lung cancer in patients not eligible for surgery or radiotherapy, and as a palliative treatment for certain patients suffering from esophageal cancer. ''Unfortunately, most of the estimated 171,500 Americans who will be diagnosed with lung cancer this year will be diagnosed at a fairly late stage in the progression of this deadly disease,'' said Dr. Harvey Pass, Professor of Surgery and Oncology at the Karmanos Cancer Institute, Wayne State University, in Detroit, Michigan. ''A significant number of these lung cancer patients will eventually suffer bronchial obstruction and hemorrhaging as the disease progresses, and photodynamic therapy with PHOTOFRIN(R) offers patients and oncologists alike an effective alternative palliative treatment.'' In clinical studies involving over 200 patients, PHOTOFRIN(R) reduced obstruction of the airways caused by a tumor in 60% of patients. Clinically significant relief of at least one of the associated disease symptoms (shortness of breath, cough, tumor bleeding) was experienced by 40% of patients. Principal side effects include a skin sensitivity to light for four to six weeks. Following the procedure, approximately 10% of patients also experience inflammation at the treatment site causing temporary fever, bronchitis, chest pain and shortness of breath. Following injection, PHOTOFRIN(R) selectively concentrates in tumor cells while largely clearing from normal tissue. Activation of PHOTOFRIN(R) by a non-thermal laser light at the tumor site produces a toxic form of oxygen that destroys the cancer cells. Necrotic tissue and exudate are subsequently removed later through a bronchoscope. The FDA approval includes marketing clearance for laser systems and a fiber optic used to activate PHOTOFRIN(R). The device approvals include: Laserscope's PDT Laser Systems (Series 600 and 630 PDT Dye Modules and Series 800 Surgical Laser Systems); Coherent's photodynamic lasers (Lambda Plus PDL1 and PDL2); and the OPTIGUIDE(TM) Cylindrical Fiber Optic Diffusers. QLT PhotoTherapeutics Inc. is a world leader in the development and commercialization of proprietary pharmaceutical products for use in photodynamic therapy, an emerging field of medicine utilizing light-activated drugs in the treatment of disease. QLT's innovative science has advanced photodynamic therapy beyond applications in cancer towards potential breakthrough treatments in ophthalmology and autoimmune disease. QLT's portfolio of products include PHOTOFRIN(R) (porfimer sodium), the world's only approved photodynamic therapy drug, used in the treatment of various cancers throughout North America, Japan and Europe; and VisudyneT (verteporfin), a therapy in final stages of testing to treat the wet form of age-related macular degeneration (AMD), the leading cause of blindness among the elderly. The Company is listed on the NASDAQ Stock Market under the trading symbol ''QLTIF'' and on The Toronto Stock Exchange under the trading symbol ''QLT.'' The foregoing information contains forward-looking statements which involve known and unknown risks, uncertainties and other factors which may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Such factors include: risks associated with the commercialization of PHOTOFRIN(R) and verteporfin; uncertainties relating to clinical trials and product development; the Company's history of operating losses and uncertainty of future profitability; rapid technological change and competition; uncertainty regarding patents and proprietary rights; product liability claims and insurance; manufacturing uncertainties; uncertainty of pricing and reimbursement; no assurance of regulatory approval; government regulation; and dependence on corporate relationships; among others, all as described in the Company's Annual Information Form on Form 10-K. Hope everyone has a great Xmas, and hopefully a financially sound 1999. Garry