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news.Taiwan Liposome and Aptuit Consulting, a subsidiary of Aptuit, has announced that Taiwan Liposome's Lipotecan cleared review by the FDA following the filing of an investigational new drug application, the first anticancer drug from Taiwan to achieve this milestone.
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Aptuit Consulting, Aptuit’s global pharmaceutical drug development consultancy, managed the investigational new drug (IND)-enabling studies from manufacturing through IND submission and is engaged in the Phase I program.
Taiwan Liposome Company (TLC) will start the Phase I study of Lipotecan as a chemotherapeutic drug in US and is planning to launch a Phase I study in Asia in the fourth quarter of 2008. The Phase I study will be a typical open-label, dose-escalation safety, tolerability and pharmacokinetic study in patients with solid tumors.
Lipotecan is a chemically modified camptothecin designed to improve stability and potency and to minimize toxicity. It will eventually be evaluated for use as monotherapy or in combination with approved chemotherapeutic agents.
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.
Keelung Hong, CEO and chairman of TLC, said: “The success of Lipotecan entering Phase I clinical trials is a critical milestone for TLC, demonstrating our ability to develop new small molecule drug candidates for cancer treatments.”