Cephalon Inc. said Tuesday that it is starting clinical trials ofMyotrophin, its recombinant insulin-like growth factor, in Japan. Thestudy will evaluate the safety and pharmacokinetics of the drug inhealthy volunteers.The beginning of trials in Japan is keeping with the West Chester, Pa.,company's plan to pursue worldwide development of Mytrophin,which primarily is indicated for treatment of amyotrophic lateralsclerosis (ALS), or Lou Gehrig's disease, and peripheral neuropathies,Mary Fisher, manager of corporate communications for Cephalon, toldBioWorld.Cephalon currently is conducting Phase II/III trials in 16 centers inNorth America and Europe for ALS. The company plans to beginNorth American Phase II studies of Myotrophin in peripheralneuropathies later this year.Last July, Cephalon and Kyowa Hakko Kogyo Co. Ltd., of Tokyo,signed an agreement in which the Japanese company would fund allproduct development activity of Myotrophin in that country. KyowaHakko will conduct the clinicals in Japan as well as seek registration inthat country to market the product.Cephalon will be paid licensing fees, milestone payments and certainroyalties. It also has an option to co-promote Myotrophin in Japan withKyowa Hakko.In the initial study, on about six people, Kyowa Hakko will providefunding while Cephalon will conduct the trial, Fisher said.
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