Manhattan Initiates Patient Dosing in Phase Ib Oleoyl Estrone Clinical Trial

Manhattan Pharmaceuticals has concluded its Phase Ia trial and begun patient dosing in the Phase Ib trial to evaluate the safety and tolerability of defined doses of orally administered Oleoyl estrone (OE) in obese adults.

Like the Phase Ia trial, the Phase Ib trial will be conducted in Basel, Switzerland, under Swiss Medic Approval. The Phase Ia trial, conducted with the approval of the U.S. FDA and SwissMedic, the Swiss regulatory authority, was a single-dose, dose-escalation trial that evaluated six cohorts of six patients.

Manhattan is currently reviewing and analyzing the results of the trial, which will ultimately be used to obtain approval to move forward with Phase II studies. Results from this study will also be used, in conjunction with extensive preclinical work, to establish the protocol and obtain approval from the FDA to begin Phase II clinical trials.