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news.Manhattan Pharmaceuticals has been granted FDA approval to begin phase I human clinical trials of its lead product candidate, Oleoyl estrone, an orally administered obesity therapeutic.
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This investigational new drug (IND) allowance moves Manhattan forward into the next stage of Oleoyl estrone (OE)’s development and was granted on the preclinical chemistry, manufacturing, and safety data submitted to the FDA by Manhattan Pharmaceuticals.
Manhattan, which recently signed a merger agreement with Tarpan Therapeutics, expects to commence a phase I clinical trial in Switzerland in the first quarter of 2005. The company has already gained approval from the Swiss governmental medical regulatory authority, SwissMedic, to initiate human trials. The trial is designed to evaluate the safety and tolerability of defined doses of orally administered OE in obese adults.
In November 2003, Manhattan announced the first peer reviewed publication reporting human physiologic responses to OE, including marked weight loss, during 27 months of oral administration. More recently, company scientists reported favorable preclinical toxicology data for OE and additional pharmacology data.