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Amylin to expand integrated obesity study
New York | Thursday, October 26, 2006, 08:00 Hrs  [IST]

Amylin Pharmaceuticals, Inc. has announced an extensive programme of clinical trials, which will assess the safety and efficacy of multiple neurohormones, used in combination to treat obesity.

This integrated approach to obesity therapy is based on extensive clinical experience with the analog of the human hormone, amylin, called pramlintide, and pre clinical data combining neurohormones. Results has presented from a phase 2 extension study demonstrate that patients completing 52 weeks of pramlintide therapy experienced a 7-8 per cent mean body weight reduction (depending upon dose) compared to a 1 per cent reduction in patients receiving placebo. Also, pre clinical data were presented revealing novel, additive and synergistic weight loss effects when amylin is used in combination with other neurohormones.

Four of the clinical studies will be conducted using pramlintide in combination with Leptin, PYY 3-36, and approved oral anti-obesity agents. The fifth clinical study will evaluate an amylin mimetic designed to have enhanced anti-obesity properties. An Investigational New Drug application was recently submitted to the Food and Drug Administration for this drug candidate.

"Amylin's research is focused on novel peptide hormones and their potential to treat a wide range of complex diseases," said Ginger L Graham, CEO of Amylin Pharmaceuticals. "This approach has been applied successfully to diabetes with the introduction of Byetta and Symlin. Today we announced a new clinical research programme, which applies this scientific strategy to address the global epidemic of obesity."

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialisation of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, Symlin (pramlintide acetate) injection and Byetta (exenatide) injection. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes, obesity and cardiovascular disease.

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