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S2-5
舊藥新用研發經驗分享-從骨骼到關節再生
An Experience in Drug Development for New Indication- From Bone to Joint Regeneration
何美泠 Mei-Ling Ho, Ph.D.
Professor, Physiology, College of Medicine
Director, Orthopaedic Research Center
Dean, Office for Operation of Industry and University Cooperation
Kaohsiung Medical University
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| It has been an attractive goal for a research to apply the invention from bench to bedside. It usually takes one to two decades for a new drug invention. This presentation is to share the experience in these years. Parathyroid hormone (1?34), PTH (1?34), has been used as an osteoporosis drug clinically by subcutaneous administration. Our study is to develop PTH(1?34) on osteoarthritis (OA) treatment as a new drug for OA indication and intra-articular (IA) administration way. Two important check points to go over the dead-valley are scientific proof and industrial transfer. The pre?clinical study is conducted for applying the finding from bench to bedside. We have been proven the concept in papain?induced OA in SD rats, anterior cruciate ligament transection (ACLT)?induced OA in SD rats as the post?traumatic OA, and aging related OA in Hartley guinea pigs. We also found that the effective dose range of PTH is 0.1?100nM that is 500-1000 folds less than that used in osteoporosis. The ongoing study is to confirm the efficacy in large animals (goat), and to test toxicology of PTH(1?34) for the IA administration way. The other important check point is to collaborate with pharmaceutic company. We have worked together with TSH Co. for 5 years, and will start-up new company in near future. |
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