Joint NIH and LSBC Studies With Plant-Produced Alpha-Galactosidase Show Its Potential for Enzyme Replacement Therapy in Fabry Disease.Business Editors/Health/Medical Writers VACAVILLE, Calif.--(BUSINESS WIRE)--Jan. 20, 2004 Large Scale Biology Corporation (Nasdaq:LSBC LSBC Law Society of British Columbia LSBC Large Scale Biology Corporation LSBC Lone Star Bulldog Club LSBC Lasalle & Bureau County Railroad Company LSBC Lifesaver for Babies and Children (St John Ambulance, UK) LSBC Lone Star Bit Company ) today announced that its plant-produced human therapeutic enzyme, alpha-galactosidase A, showed positive results in preclinical studies preclinical studies, n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research. using an animal model of Fabry disease. The results were published this week by researchers at the National Institutes of Health's National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke is a part of the U.S. National Institutes of Health. The NINDS conducts and supports research on brain and nervous system disorders. Created by the U.S. (NIH/NINDS) and LSBC scientists. The studies demonstrated potential for using LSBC's plant-manufactured alpha-galactosidase in 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 Fabry disease and suggest further development of the product towards evaluation of its safety and efficacy in humans. Fabry disease is an X-linked lysosomal lysosomal pertaining to or emanating from lysosomes. lysosomal enzymes enzymes located in the lysosomes. lysosomal phospholipidosis storage disorder resulting in the accumulation of lipids in multiple organs, including the heart, liver and kidney. This life-long affliction impacts male patients in particular, with high morbidity and mortality Morbidity and Mortality can refer to:
A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) between LSBC and Dr. Brady's laboratory, demonstrated that a potentially clinically relevant enzyme can be made in plants. The study showed that significant reductions of excess lipids (GB3), characteristic of Fabry disease, can be achieved in target organs. Tissue distribution studies showed proper targeting of the enzyme to affected organs and no apparent toxicity or tissue damage in the animal model. Also, no neutralizing antibodies were observed in extended infusion studies, suggesting that LSBC's therapeutic enzyme does not elicit undesirable immune responses in the animal model. "The highly productive CRADA between Dr. Brady's laboratory and LSBC has yielded excellent results in our alpha-galactosidase program," stated Kevin Ryan, LSBC's President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "The results of this collaborative research have encouraged further development of our alpha-galactosidase product as a near-term clinical target. Our ability to manufacture large quantities of this enzyme cost-effectively provides the basis for developing an improved product to satisfy unmet needs, such as the prophylactic treatment prophylactic treatment n. The institution of measures to protect a person from a disease to which he or she has been, or may be, exposed. Also called preventive treatment. of Fabry patients," said Mr. Ryan. "Concern in the Fabry community over continued unavailability of Fabry therapeutics for the earlier treatment of patients, including women and children, will guide LSBC's clinical plans," Mr. Ryan added. In 2003, the US Food and Drug Administration granted LSBC's alpha-galactosidase enzyme Orphan Drug designation. This year, LSBC plans to initiate GLP See gateway location protocol. safety studies as a step toward filing an IND and initiating clinical trials. For additional information on LSBC's recombinant alpha-galactosidase A product, please contact: Daniel Tuse, Ph.D. Vice President Business Development Tel 707 469 2316 Fax 707 446 3917 Email: daniel.tuse@lsbc.com About Large Scale Biology Corporation Large Scale Biology uses its gene discovery and protein improvement and biomanufacturing technologies to develop and manufacture biotherapeutics and vaccines for the effective treatment of disease. Corporate headquarters, molecular biology, product design, and Eclipse Diagnostics, Inc., are located in Vacaville, California, and the Company's bioprocess bi·o·proc·ess n. 1. A technique that produces a biological material, such as a genetically engineered microbial strain, for commercial use. 2. development and commercial-scale biomanufacturing facilities are located in Owensboro, Kentucky. For more information about Large Scale Biology Corporation, visit the Company's website at www.lsbc.com. For more information on LSBC's wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. diagnostics company, Eclipse Diagnostics, visit their website at www.eclipsediagnostics.com. This release contains forward-looking statements about an application of LSBC's technologies and a commercial opportunity for one of our products. These forward-looking statements involve risks, uncertainties and situations that may cause our actual results to differ materially from those implied by these statements, including our ability to commercialize one of our products, the ability of our collaborators to generate demand for products we make for them, the effectiveness of our and our collaborators' technologies to produce specific products and/or in a cost-effective manner, any difficulties or delays in obtaining regulatory approval to test and market such products, and the requirement of substantial funding for us to preserve our technology base and product pipeline. We cannot guarantee future results. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this release. For a further list and description of such risks and uncertainties see the reports filed by Large Scale Biology Corporation with the Securities and Exchange Commission, including our reports on Forms 10-K and 10-Q. Except as required by law, we do not undertake to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. LSBC(R) is a trademark of Large Scale Biology Corporation. |
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