In addition to recruiting patients in Switzerland, where the phase IIa trial was initiated in May 2006, the study will now also begin recruiting patients at Jean Brown Research in Salt Lake City, and at Pennington Biomedical Research Center in Baton Rouge. Screening of patients has already begun and dosing is expected to take place in mid November 2006.
This ongoing phase IIa study is designed to evaluate the safety, preliminary efficacy, and pharmacokinetics of oral Oleoyl-estrone (OE) compared to placebo. 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.
Manhattan Pharmaceuticals also recently initiated a second phase IIa clinical trial of OE in morbidly obese male subjects. OE is an orally administered, synthetic form of Oleoyl-estrone, a molecule that exists naturally in the body.