Amgen Starts First Leptin Trials In Humans

Us biotechnology firm Amgen has now started human clinical trials of leptin, a recombinant form of the natural human protein produced by the obese (ob) gene and made in fat cells. Preclinical data (Marketletter July 31, 1995) suggest that leptin helps regulate body fat deposition and, as a result, produces weight loss through effects on a person's metabolism and appetite.

The initial study, being conducted at multiple centers in North America, is designed primarily to evaluate safety and tolerability of leptin across a variety of weight categories of people who have no other medical complications.

Last April, Amgen acquired an exclusive license from the Rockefeller University to develop and market products based on the discovery of the ob gene by a research team led by Jeffrey Friedman, head of Rockefeller's laboratory of molecular genetics, and a Howard Hughes Medical Institute investigator. The start of this first clinical trial comes only one year after acquiring development rights and less than two years after the gene's discovery, Amgen notes.