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[IP] Drug for Complications Continues to Show Promise in Human Trials

I'm not sure how many of you receive JDRF updates, but I received the
following in an e-mail and thought the results were worth sharing:

New York, NY, July 17, 2002 +IBQ Scientists still do not fully understand how
high blood glucose translates into damage to the eyes, nerves and kidneys of
people with diabetes. But researchers working to block these outcomes know
that a detailed clarification of the entire pathway to disease is not required
if they can simply find a way to block the cascade of events at some point.
For example, many effective drugs exist to block high blood pressure even
though the cause in most cases remains unknown. 

One target that researchers looking to prevent diabetes-related complications
have focused attention on is an enzyme called protein kinase C beta (PKC),
which regulates a number of important cellular functions. When blood glucose
levels are high, PKC is activated and starts a chain of events that damages
small blood vessels, making them leak. This harmful pathway has been
implicated broadly in complications of type 1 diabetes, including eye diseases
such as diabetic retinopathy and diabetic macular edema, and nerve damage, or

Blocking PKC 

Because of PKC's role in these complications, scientists have been trying to
develop a drug+IBQ-a "PKC inhibitor"+IBQ-that could block its effects and
possibly prevent retinopathy and neuropathy.  Scientists have been developing
drugs that act as a PKC inhibitor, in the attempt to block or prevent
complications.  At a recent scientific meeting, the drug company Eli Lilly
presented encouraging results from a Phase 2 clinical trial in which a
compound called LY333531 positively impacted nerve function and sensory
symptoms. Patients taking the compound reported improvements in such symptoms
as numbness and tingling. The company says it is already recruiting patients
for Phase 3 studies, and it expects to file for regulatory approval for the
treatment of symptoms of diabetic peripheral neuropathy in the U.S. in 2004. 

Eli Lilly also is investigating PKC beta inhibitor as a potential treatment
for diabetic retinopathy and diabetic macular edema. The company is preparing
to begin Phase 3 trials with LY333531 and plans to file for regulatory
approval of the drug in Europe for diabetic retinopathy and diabetic macular
edema in 2003 and in the U.S. in 2005. 

Background: JDRF Helped Fund Research Leading to the Drug

The journey of LY333531 from laboratory to human trials illustrates JDRF's
commitment to leveraging its funds in the most effective way. The Foundation
supports innovative scientists as they conduct basic research, investigating
theories and testing new compounds as possible treatments. After a potential
drug has shown promise, pharmaceutical companies are better suited to commit
resources to develop it further by conducting large-scale clinical trials. 

For example, the theory that PKC may be contributing to damage of small blood
vessels was first proposed in the research laboratory of George King, M.D.,
professor of medicine at Harvard Medical School. (Dr. King and his colleagues
were mainly studying PKC's role in retinopathy and the possibility that
LY333531 could hinder retinopathy; the drug's effectiveness against neuropathy
was not appreciated until later.) In 1999, Dr. King received a special grant
of $1.1 million over three years from JDRF to develop this idea further and
begin testing it in early lab studies. Subsequently, Eli Lilly was able to
provide for Dr. King and his colleagues the research support needed to bring
the compound into the drug pipeline. 

To read the Eli Lilly news release on the drug, click below:


To read a new JDRF Web site feature story on the drug and other JDRF-funded
projects in complications, click below:

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