Glyko Biomedical Ltd.'s 27%-owned Affiliate, BioMarin Files CTX To Conduct Clinical Trial of Vibriolysin Topical To Treat Serious Burns.Business/Health Editors NOVATO, Calif.--(BW HealthWire)--June 25, 2001 Glyko Biomedical Ltd.'s (OTCBB OTCBB See OTC Bulletin Board (OTCBB). : GLYK; TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). : GBL GBL Gamma-Butyrolactone GBL government bill of lading (US DoD) GBL Ground-Based Laser GBL Game Boy Light GBL General Bearing Line GBL Generation Breakdown List GBL Ground-Based Laboratory GBL Green Bus Lines, Inc. ; BVD-Berlin: GLY Gly glycine. Gly abbr. glycine Gly glycine. ) 27%-owned affiliate, BioMarin Pharmaceutical Inc. (Nasdaq and SWX SWX Swiss Exchange (trademark of SWX Swiss Exchange) SWX SolidWorks (3D solid modeling CAD software) SWX Splitter / Wave Division Multiplexer New Market: BMRN) today announced that it has filed a Clinical Trial Exemption (CTX CTX Context (Management; Tandem) CTX Centex Corporation (stock symbol) CTX Centrex CTX Cyclophosphamide CTX Corporate Trade Exchange CTX Cytoxan CTX Cholera Toxin CTX Clinical Trial Exemption ) application with the Medicines Control Agency (MCA MCA in full Music Corporation of America Entertainment conglomerate. It was founded in Chicago in 1924 by Jules Stein as a talent agency. In the 1960s it bought Decca Records and Universal Pictures, and today it produces films, music, and television shows. ) in the United Kingdom for permission to conduct a human clinical trial of Vibriolysin Topical in patients with serious burns. Vibriolysin Topical has displayed promising efficacy in numerous preclinical studies related to the debridement Debridement Definition Debridement is the process of removing nonliving tissue from pressure ulcers, burns, and other wounds. Purpose Debridement speeds the healing of pressure ulcers, burns, and other wounds. (cleaning) of dead tissue resulting from serious burns. Pending approval of the CTX by the MCA, BioMarin anticipates initiating a clinical trial of Vibriolysin Topical in the United Kingdom. Fredric D. Price, Chairman and Chief Executive Officer of BioMarin, said, "Vibriolysin Topical will represent BioMarin's third enzyme-based product to be tested in humans. In the second half of 2001, we will unblind Un`blind´ v. t. 1. To free from blindness; to give or restore sight to; to open the eyes of. data from our first two clinical programs: our Phase III trial of Aldurazyme(TM) for the treatment of MPS-I and our Phase I trial of rhASB for the treatment of MPS-VI. Filing the CTX for Vibriolysin Topical further demonstrates the Company's commitment to developing novel enzyme therapies for unmet medical needs." Treatment of an acute burn injury requires the removal of dead tissue to enable healing. Depending on the depth and location of the wound, debridement may be attempted by topical drug treatment or manual methods that have been devised to reduce the blood loss and pain inherent in surgery. According to the American Burn Association, there are approximately 45,000 patients per year with serious burns admitted to hospitals and specialized burn centers in the United States. BioMarin believes there is a significant number of burn patients in other countries in the developed world who could also potentially benefit from a new debridement treatment. Stuart J. Swiedler, MD, PhD, BioMarin's Vice President, Scientific and Clinical Affairs, said, "Vibriolysin Topical's unique propensity for selectively breaking down dead tissue without digesting healthy tissue, as demonstrated in preclinical studies, suggests that Vibriolysin Topical may offer physicians treating burns a safe and effective alternative to surgery and other less effective topical drugs for the debridement of burn wounds." Photographs documenting the ability of Vibriolysin Topical to debride burn wounds may be found by visiting BioMarin's website at: www.biomarinpharm.com/vibriolysin. Glyko Biomedical Ltd.'s principal asset is a 27% ownership in the capital stock of BioMarin Pharmaceutical Inc. BioMarin specializes in the development and commercialization of therapeutic enzyme products. Since inception in 1997, BioMarin has applied its proprietary enzyme technology to develop products for lysosomal storage diseases lysosomal storage diseases A heterogeneous group of diseases with specific lysosomal enzyme defects. Cf Inborn errors of metabolism. and for the treatment of serious burns. Glyko, Inc., a BioMarin subsidiary, provides analytical and diagnostic products and services in the area of carbohydrate biology. This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including the following potential future products: Aldurazyme for MPS-I; rhASB for MPS-VI; and Vibriolysin Topical for serious burns. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. Results may differ materially depending on the progress of BioMarin's product programs, the results of current and proposed clinical trials, actions of regulatory authorities, including the Medicines Control Agency's actions on the Clinical Trial Exemption application, availability of capital, future actions in the pharmaceutical market and developments by competitors, and those factors detailed in BioMarin's filings with the Securities and Exchange Commission such as 10Q, 10K and 8K reports. Stockholders are urged not to place undo reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation, to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise. Note to Editors: Aldurazyme is a trademark of BioMarin/Genzyme LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control . All rights reserved. |
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