FOR RELEASE: April 29, 1998
Contact:
Blaine P. Friedlander, Jr.
Office: (607) 255-3290
E-Mail: [email protected]
Compuserve: Bill Steele, 72650,565
http://www.news.cornell.edu
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 company's 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 three 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 this 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 delivery 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 technology to protect the environment and improve human health and well-being.
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