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Phase 1 Study Initiated for Biodel, Inc.’s (BIOD) Insulin Formulations

May 10, 2011 1:51 PM ETALBO
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Biodel, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. The company develops it products by applying its proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.

The company announced today that an independent investigator initiated a pump trial of Biodel’s two ultra-rapid-acting formulations of recombinant human insulin. Insulin pump therapy is used as a means to provide intensive insulin therapy to patients with diabetes.

Currently available prandial insulins are used in pumps, but often are not absorbed rapidly enough to achieve optimal mealtime glucose control. It is believed than an ultra-rapid-acting insulin will be better suited for pump therapy than currently marketed mealtime insulin analogs. Biodel’s two formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed mealtime insulin analogs.

This study will be conducted at Oregon Health and Sciences University. It is designed as a double-blinded, three-period crossover trial in which insulin pumps will be used to deliver BIOD-105, BIOD-107 and Humalog each at separate dosing visits in approximately eight patients with type 1 diabetes. This study will be completed in the fourth quarter of 2011. It will evaluate pharmacokinetic, pharmacodynamic and injection site tolerability profiles of BIOD-105 and BIOD-107 relative to that of Humalog which is currently on the market.

For further information on Biodel, please visit the company’s website at biodel.com

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