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www.fdanews.com/articles/90506-manhattan-pharma-completes-enrollment-in-obesity-study

MANHATTAN PHARMA COMPLETES ENROLLMENT IN OBESITY STUDY

February 23, 2007

Manhattan Pharmaceuticals announced it has completed patient enrollment in its first Phase IIa, multicenter, international clinical study evaluating the safety and preliminary efficacy of oral oleoyl-estrone (OE) for the treatment of obesity. This randomized, double-blind, placebo-controlled, parallel-group study enrolled 100 patients at two clinical trial sites in the U.S. and one in Europe.

The study is evaluating obese adult subjects with body mass indexes of 27 to 38.9. Each subject has been randomized into one of four treatment groups to evaluate the safety, preliminary efficacy and pharmacokinetics of two 14-day dosing cycles of 5, 10 or 20 mg of oral OE compared with placebo given once daily during each dosing cycle. Each 14-day dosing cycle is followed by a 28-day treatment-free evaluation period. In addition to safety and tolerability, this study is also designed to further evaluate weight loss, maintenance of weight loss and other therapeutic outcomes.

The company is also conducting a second Phase IIa clinical study of OE in morbidly obese male subjects.

The drug is an orally administered, synthetic form of OE, a molecule that exists naturally in the body. Based on extensive preclinical studies, it is believed to work by a dual mechanism of action. Centrally, OE appears to act at the brain's hypothalamus, resetting the body's ponderostat, the food control center in the brain that detects and integrates signals that control both appetite and metabolic behavior, according to the company. Peripherally, OE also causes reduced storage of fat in white fat tissue and allows skeletal muscle to use fat as an alternate energy source.