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Back To Vidyya Inhaleable Insulin Closer To Reality

New Study Shows Nasal Form Of Drug Effective For Up To 30 Months

Inhale Therapeutic Systems, Inc. reported on new data from a study being conducted by Pfizer Inc. and Aventis Pharma with their inhaleable insulin. The study focused on diabetic patients who continued on the inhaleable therapy for up to 30 months. The data was released at the annual meeting of the American Diabetes Association in San Antonio, Texas by clinical investigator William T. Cefalu, M.D., of the University of Vermont earlier this week.

Dr. Cefalu reported the data from a Phase II extension study conducted to determine whether results from previously reported short-term clinical trials could be maintained long-term. The study included type 1 and type 2 diabetic patients previously treated with insulin injections and type 2 patients who had failed to control their disease with oral agents. Patients had completed any of these three randomized, three-month Phase II trials of inhaleable insulin.

These Data Show That Hba1c Levels -- The Long-Term Measurement Of Blood Glucose Control -- Remained Stable In Patients For Up To 30 Months Of Therapy. Pooled Efficacy Data Was Presented Showing Hba1c At 8.7% At Baseline; 8.1% At 12 Months; 8.0% At 18 Months; And 8.0% At 24 Months. At The Time That This Data Was Compiled, 83 Patients Had Completed 24 Months Of Inhaleable Therapy. Further Data Presented Indicated Continued Efficacy For Patients Who Completed 30 Months Of Therapy. Additionally, Safety Data From Four Different Lung Function Tests Showed That Lung Function Was Stable During The Course Of Treatment.

Inhale is pioneering drug delivery systems to easily deliver a range of inhaleable drugs, including peptides, proteins and small molecules, to the deep lung for treatment of systemic and respiratory diseases. The company has development partnerships with several major pharmaceutical and biotechnology companies, including Pfizer, Aventis Behring (formerly Centeron), Biogen and Lilly. Pfizer Inc. is in collaboration with Inhale, who is developing the inhalation device and powdered insulin. Inhaleable insulin is being developed jointly by Pfizer Inc. and Aventis Pharma (formerly Hoechst Marion Roussel). Pfizer and Aventis Pharma have entered into agreements to manufacture insulin and co-develop, co-promote inhaleable insulin.

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Editor: Susan K. Boyer, RN
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