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
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.