Forbes Files IND for Phase II Trial.VANCOUVER, BRITISH COLUMBIA--(BUSINESS WIRE)--Dec. 16, 1997--FORBES MEDI-TECH (VSE See DOS/VSE. VSE - Virtual Storage Extended :FMI FMI Fondo Monetario Internacional (Spanish: International Monetary Fund) FMI Fonds Monétaire International FMI For More Information FMI Food Marketing Institute FMI Fundo Monetário Internacional .) Forbes Medi-Tech Inc. (VSE:FMI) (the "Company") is pleased to announce that it has filed an Investigational New Drug application (IND) with the US 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. ) for a Phase II clinical study with CARDIOREX(TM) for the treatment of primary hypercholesterolemia (elevated cholesterol). The submission was made following a review by GloboMax LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control , a Maryland company providing regulatory strategic planning and management. GloboMax, which has been selected to manage the FDA regulatory process for Forbes, has personnel that include Dr. Keith Chan, a former Director, and Dr. William Gillespie, a former Associate Director at the FDA. Two clinical research centres have been selected to conduct the planned Phase II trial. The US centre will be at the Clinical Trial Research Institute at Oregon Health Sciences University under the direction of Dr. William Connor, Professor of Medicine and Head of Division of Endocrinology, Metabolism and Clinical Nutrition, Department of Medicine. Dr. Connor and the Clinical Trial Research Institute are internationally recognized for their work in clinical lipidology. In addition to the FDA IND submission, the Company has also submitted a pre-IND package to the Canadian Health Protection Branch (HPB HPB Health Promotion Board (Singapore) HPB Hrvatska Poštanska Banka (Croatian Post Bank) HPB Half Price Books (retail store) HPB High Ping Bastard ) as the established prerequisite to the final IND submission. McGill University has been selected as the second clinical research centre which will participate in the Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II under the direction of Dr. Peter Jones, Professor and Director, School of Dietetics dietetics /di·e·tet·ics/ (-iks) the science of diet and nutrition. di·e·tet·ics n. The branch of therapeutics concerned with the practical application of diet in relation to health and disease. and Human Nutrition. Dr. Jones' centre at McGill University is a well recognized facility for conducting human cholesterol-lowering trials. These two trial centres are expected to enroll approximately 60 patients in total. ON BEHALF OF THE BOARD OF DIRECTORS OF FORBES MEDI-TECH INC. Egon Novak, MD, Ph.D., Medical Director FORBES MEDI-TECH is a Vancouver-based biotechnology company dedicated to research, development and commercialization of pharmaceutical and nutraceutical products derived from forest industry by-products. By extracting plant sterols sterols (ster´ôlz), n.pl steroids having one or more hydroxyl groups and no carbonyl or carboxyl groups (e.g., cholesterol). from tall oil soap, a pulping by-product, Forbes is developing cholesterol-lowering agents to be used as pharmaceutical therapeutics and food supplements in the battle against heart disease. Forbes is also developing innovative technology that converts plant sterols into pharmaceutical fine chemicals, essential in the manufacturing of various pharmaceutical steroids. Using the base products of these technologies, Forbes is further developing methods for the production of "higher value" steroids such as sex hormones and birth control agents. The statements made in this News Release may contain certain forward-looking statements. Actual events or results may differ from the Company's expectations. Certain risk factors may also affect the actual results achieved by the Company. Exemption from registration pursuant to Rule 12(g)3-2(b) 82-3139. The Vancouver Stock Exchange Vancouver Stock Exchange (VSE) A securities and options exchange in Vancouver, British Columbia, (Canada), specializing in venture capital companies. Vancouver Stock Exchange See Canadian Venture Exchange (CDNX). has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this News Release. CONTACT: Forbes Medi-Tech Inc. Don Lay, 604/ 681-8976 E-mail: ir@forbesmedi-tech.com Website: http://www.forbesmedi-tech.com |
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