Genexol-PM is a polymeric micelle formulated paclitaxel, free of Cremophor EL. Objectives with Genexol-PM are to reduce Cremophor EL-related toxicities and to increase therapeutic efficacy. Polymeric micelles are composed of hundreds of amphiphilic diblock copolymers. Block copolymers include poly-(ethylene glycol) used as nonimmunogenic carriers and biodegradable core-forming poly-(D,L-lactic acid) to solubilize hydrophobic drug. Genexol-PM showed 3-times higher maximum tolerated dose in mice vs. Taxol. Genexol-PM (vs. Taxol) showed 2-3-fold higher levels of paclitaxel in tissues including liver, spleen, kidney, lung, and tumors. In vivo antitumor efficacy of Genexol-PM was significantly higher than Taxol. Based on results from Phase I and II trials in Korea/US, the therapeutic dose recommended is 300mg/m2, much higher than Taxol (175 mg/m2). With favorable results from Phase II studies - Breast/Lung Cancer, Genexol-PM obtained a pre-market approval in Korea in July 2006. A phase IIa pancreatic cancer trial is on-going in US.
Samyang has registered patents for the drug composition and method of
preparation for Genexol-PM. The patents are registered in eight countries,
including Korea, US, Japan, China, Canada, Mexico, Australia and Europe
(EP). Europe includes Great Britain, Germany, Spain, France, Italy, Holland,
Belgium, Switzerland and Sweden.
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