FDAnews
www.fdanews.com/articles/72751-study-provides-new-information-on-efficacy-of-obesity-treatment-candidate

Study Provides New Information on Efficacy of Obesity Treatment Candidate

May 27, 2005

Oleoyl-estrone (OE), the lead product candidate of Manhattan Pharmaceuticals, demonstrated efficacy in inducing significant weight loss in a preclinical pharmacology study when administered alone and in combination with other obesity treatments.

Findings of the study, conducted by Professor Maria Alemany from the University of Barcelona and lead research scientists on OE were published in a paper titled, "Effects of Oleoyl-estrone with Dexfenfluramine, Sibutramine or Phentermine on Overweight Rats," in the April 2005 issue of the European Journal of Pharmacology.

For the study, eight groups of six male wistar rats were dosed with Oleoyl-estrone, dexfenfluramine, sibutramine, or phentermine alone; Oleoyl-estrone in combination with dexfenfluramine, sibutramine, or phentermine; or a placebo, for 10 days. Food intake, weight loss, levels of insulin, cholesterol and triacylglycerol were measured on a daily basis.

Rats dosed with Oleoyl-estrone showed a weight loss of 0.8 percent per day versus less than 0.4 percent for dexfenfluramine or sibutramine, and no weight loss with phentermine. Rats dosed with Oleoyl-estrone showed lower levels of triacylglycerol, cholesterol, and insulin together with a lower homeostasis model assessment (HOMA) score. Weight loss was maximal when Oleoyl-estrone was combined with sibutramine and dexfenfluramine, with losses of 1 percent and 1.1 percent per day respectively. Oleoyl-estrone combined with sibutramine resulted in the highest lipid loss of all the groups -- 29 percent over 10 days, without dietary constraints. Food intake decreased across all groups, except those animals treated with phentermine.