>>SUNNYVALE, Calif., Nov. 5 /PRNewswire/ -- Speaking today before the CIBC World Markets Twelfth Annual Health Care Conference in New York, Aerogen, Inc. (Nasdaq: AEGN - news) presented the results of its second Phase 2 inhaled insulin study using the Aerodose® insulin inhaler.
The study compared the dose-response relationship of absorption and metabolic action of liquid insulin when delivered via the Aerodose insulin inhaler and by subcutaneous injection. Twenty-four Type 2 diabetes patients each received 2 of 3 dosage levels of 8, 16 or 24 units of subcutaneously injected insulin and corresponding doses of inhaled insulin. The study was conducted by Dr. Robert Henry at the Veterans Affairs San Diego Healthcare System, San Diego, California.
The results of the study revealed a linear dose-response relationship for both drug absorption and metabolic effect following both inhalation and subcutaneous administration of insulin. Relative bioavailability of inhaled insulin compared to subcutaneously administered insulin averaged 21% and was consistent across the dose range studied. Peak serum insulin levels and associated metabolic effects were attained more rapidly with inhaled insulin than with subcutaneous injection. No clinically significant changes in pulmonary function were observed during the study.
According to Dr. Henry, ``The study's results suggest that titration of insulin using the Aerodose insulin inhaler in Type 2 diabetics will be as predictable as that following subcutaneous injection.''
Jane E. Shaw, Ph.D., Chairman and CEO of Aerogen stated, ``The results of our second Phase 2 study are very promising. Aerogen is making great progress in continuing to demonstrate the effectiveness of inhaled insulin and the efficiency of the Aerodose insulin inhaler.''
The Aerodose insulin inhaler is a small, hand-held, pocket-sized product containing Aerogen's proprietary aerosol generator that aerosolizes liquids. The aerosol generator contains a domed aperture plate with numerous precision-formed holes surrounded by a vibrational element. Vibration of the aperture plate results in a micro-pumping action that creates a fine droplet, low velocity aerosol. The inhaler is uniquely designed to provide patients with a small, discreet and easy to use product. The commercial Aerodose insulin inhaler contains a titratable cartridge that allows patients to vary their dose based on their individual needs and provides for delivery of multiple doses of insulin from a single glass cartridge.
Diabetes is a disease resulting from a deficiency in the production of insulin and/or resistance to its metabolic effects. Last year, diabetes affected approximately 16 million people in the United States and approximately 154 million people worldwide. The U.S. market for pharmaceuticals used to treat diabetes is estimated to exceed $6 billion, while the burden of treating the complications of diabetes is estimated to exceed $100 billon per year in the U.S.
Aerogen (www.aerogen.com), a pulmonary drug delivery company, is developing inhaler and nebulizer products for the treatment of respiratory disorders for its own marketing and commercialized its first product, the Aeroneb(TM) Portable Nebulizer in June 2001. Aerogen is also applying its technology to develop products in collaboration with pharmaceutical and biotechnology companies for treatment of respiratory and other disorders, including diabetes. Aerogen has four Aerodose® inhaler products in development that have advanced to Phase 2 clinical trials. Additional products are in the feasibility and pre-clinical stages of development.<<
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Looks like the same results as everybody else, so it comes down to who can get to market fastest. ARDM still in the lead as far as liquid insulin is concerned. Aerogen is down today.
Cheers, Tuck |
