Aptuit Consulting, Inc. and Taiwan Liposome Company Collaborate to Complete all IND Enabling Work and IND Submission for Novel Anti-Cancer Treatment in 12 Months
6/25/2008 10:32:51 AM
TAIPEI, Taiwan & GREENWICH, Conn.--(BUSINESS WIRE)--Taiwan Liposome Company (TLC) and Aptuit Consulting Inc., a subsidiary of Aptuit Inc., today announced that TLC’s Lipotecan® cleared review by the U.S. Food and Drug Administration (FDA) following the filing of an Investigational New Drug (IND) application, the first anti-cancer drug from Taiwan to achieve this milestone. TLC will initiate a Phase 1 trial in patients with solid tumors in 3Q08. Lipotecan® is a chemically modified camptothecin designed to improve stability and potency and to minimize toxicity. Unlike other camptothecin-derived drugs that are used solely for chemotherapy, Lipotecan® has demonstrated effects as a chemotherapeutic and radio-sensitizer in preclinical animal studies. Aptuit Consulting, Aptuit’s global pharmaceutical drug development consultancy, managed the IND-enabling studies from manufacturing through IND submission and is engaged in the Phase 1 program.
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