Glyko Biomedical Ltd.'s 27%-owned Affiliate, BioMarin Completes Treatment Stage of MPS-VI Trial.Business Editors & Health/Medical Writers NOVATO, Calif.--(BW HealthWire)--July 26, 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; BVD-Berlin: GLY Gly glycine. Gly abbr. glycine Gly glycine. ) 27%-owned affiliate, BioMarin Pharmaceutical Inc. (Nasdaq and SWX New Market: BMRN) today announced that BioMarin has completed the 24 week treatment stage of its Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of recombinant human N-acetylgalactosamine 4-sulfatase (rhASB), an enzyme replacement therapy Enzyme replacement therapy is a medical treatment replacing an enzyme in patients in whom that particular enzyme is deficient or absent. Usually this is done by giving the patient an intravenous (IV) infusion containing the enzyme. for the treatment of MPS-VI. The six patients enrolled in the trial have received all 24 of their weekly infusions required by the clinical protocol and will continue to receive therapy in the future. Following the unblinding and analysis of data from this trial, BioMarin anticipates publicly reporting detailed clinical results by the end of the third quarter, 2001. Fredric D. Price, chairman and chief executive officer of BioMarin, said, "We are pleased to report the completion of the double-blind (as to dose) treatment phase of our MPS-VI trial in accordance with our previously announced timeline. We believe that the data from this trial will provide information critical to the selection of an optimum therapeutic dose for subsequent clinical trials of rhASB." In October 2000, BioMarin initiated a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind Phase I clinical trial at Children's Hospital Oakland Children's Hospital Oakland, full name Children’s Hospital & Research Center Oakland, in Oakland, California is the only independent children’s hospital in Northern California. It is a Level I pediatric trauma center. to test the safety of rhASB at two dose levels as an enzyme replacement therapy in six MPS-VI patients. BioMarin has received orphan drug and fast track designations for rhASB from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). In addition, the European Commission has designated rhASB for the treatment of MPS-VI as an orphan medicinal product in the European Community. MPS-VI (also known as Maroteaux-Lamy Syndrome) is a debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction , life-threatening genetic disease for which no drug therapies are currently available that is caused by a deficiency of the enzyme N-acetylgalactosamine 4-sulfatase. The deficiency leads to the accumulation of glycosaminoglycans (GAGs) in the lysosomes lysosomes (līs  sōmz),n the self-contained organelles found inside most cells, which contain hydrolytic enzymes that aid in intracellular digestion. , the digestive organs of the cell. This accumulation in the lysosomes leads to progressive cellular, tissue and organ system dysfunction. Debilitating symptoms can include impaired cardiac and pulmonary function, delayed physical development, skeletal and joint deformities, impaired vision and hearing, enlarged liver and spleen, sleep disorders, and reduced endurance. Depending on the severity of the disease, patients die from disease-related complications between childhood and early adulthood. 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 prospects of rhASB. 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 data to be released when the recent rhASB trial is unblinded, the results of current and proposed clinical trials, actions of regulatory authorities, 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. |
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