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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
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
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
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.
Insulin-Pumpers website http://www.bizsystems.com/Diabetes/
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