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[IP] Cornell News: Dry insulin inhalant

     A breakthrough in insulin delivery by Boyce Thompson Institute could 
     eliminate injections for diabetes
     FOR RELEASE: April 29, 1998
     Contact: Blaine P. Friedlander, Jr.
     Office: (607) 255-3290
     E-Mail: email @ redacted
     ITHACA, N.Y. -- If current clinical trials are successful, within a 
     few years the daily insulin injection for diabetes could be a thing of 
     the past.
     A new type of dry insulin-delivery system is undergoing the second 
     phase of human clinical trials required by the Food and Drug 
     Administration (FDA). The technology to make the dry insulin is the 
     result of
     research at Boyce Thompson Institute for Plant Research Inc. (BTI), an 
     affiliate of Cornell University.
     Inhale Therapeutic Systems, San Carlos, Calif., and Initiatech Inc., 
     Brooktondale, N.Y., announced an agreement on April 14 under which 
     Inhale Therapeutic will license the BTI-developed technology. 
     The development goes back more than a decade, when Carl Leopold, the 
     W.H. Crocker Scientist Emeritus at BTI, sought to explain the 
     stability of corn and soybean seeds in the dry state. He studied seed
     cell structure and found that sugars inside the dried seed go into a 
     "glassy state," similar to the dried sugar of a hard candy. This 
     condition helps preserve essential enzymes and proteins. When 
     rehydrated, the
     glass-like particles are dissolved and the seed germinates and grows. 
     Leopold deduced that a similar protective system could be used to 
     store pharmaceutical substances.
     This finding had an important application. Insulin currently is 
     produced in liquid form and injected. Inhale Therapeutic has found 
     that insulin can be dried into a glassy state and inhaled using the 
     proprietary method of respiratory delivery, which allows particles to 
     go to the lungs, where they are absorbed by alveoli, the so-called 
     gatekeepers to the bloodstream.
     The technology developed by BTI researchers stabilizes biological 
     materials in the glassy state, making refrigeration unnecessary. A 
     diabetic can simply inhale the dried insulin through a device about 
     times larger than the inhaler used by asthmatics. The second phase of 
     FDA-required human clinical trials for this combination technology 
     will soon be ending, and the third phase is expected to begin later 
     year, according to Inhale Therapeutic.
     The company's license is to develop BTI's patents for stabilization of 
     biological materials in the dry state, exclusively for respiratory 
     delivery of pharmaceutical products and for the preservation of any 
     form of insulin. The company has six drugs in human clinical trials 
     using its pulmonary delivery system and has feasibility and 
     development partnerships with several companies.
     Initiatech has exclusive rights to the stabilization technology from 
     BTI, including the right to sublicense.
     "It is exciting to see this stabilization technology used in a manner 
     which will be beneficial to mankind and will assist in expanding the 
     usefulness of today's medicines," says Leopold.
     BTI is a not-for-profit plant research institute founded in 1924 and 
     has been affiliated with Cornell since 1974. It conducts research on 
     plant biology and continues the tradition of using science and 
     to protect the environment and improve human health and well-being.

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