MANHATTAN PHARMA EXPANDS OBESITY TRIAL TO U.S.

Manhattan Pharmaceuticals announced it has expanded the clinical trial sites for its ongoing Phase IIa study of oral Oleoyl-estrone (OE) in obese adult subjects to the United States. OE is the company's orally administered product candidate in development for the treatment of obesity.

In addition to recruiting patients in Switzerland, where the Phase IIa was initiated in May, the study is now recruiting patients in Salt Lake City and Baton Rouge, La. Screening of patients has already begun and dosing is expected to take place in mid-November.

This ongoing study is a randomized, double-blind, placebo-controlled, parallel-group study. Approximately 100 obese adult subjects with a body mass index (BMI) of 27 to 38.9 will be randomized into one of four treatment groups to evaluate 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 14-day dosing cycle. In addition to safety and tolerability, this Phase IIa study is also designed to further evaluate weight loss, maintenance of weight loss and other therapeutic outcomes.

The company also recently announced the initiation of a second Phase IIa clinical trial of OE in morbidly obese male subjects (BMI of 40 to 55).

OE is an orally administered synthetic form of oleoyl-estrone. As shown in animal studies, it is believed to work by a dual mechanism of action. Centrally, OE appears to act at the 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. Peripherally, OE also causes reduced storage of fat in white fat tissue and allows skeletal muscle to use fat as an alternate energy source.