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[IP] Encouraging Research

Subj:     Early Results of Clinical Trial Data in Diabetic Eye...
Date:     10/22/98 1:20:44 PM Eastern Daylight Time
From:     AOL News

Early Results of Clinical Trial Data in Diabetic Eye Study Are Promising,
Joslin Researchers Report


ADVANCE/BOSTON, Oct. 23 /PRNewswire/ -- A compound being evaluated as a
possible oral treatment for diabetic retinopathy, a leading cause of blindness
in adults with diabetes, was found to be safe under study conditions and to
normalize some characteristics in the eyes of people with diabetes that are
associated with eye complications, according to researchers at Joslin Diabetes

If further ongoing clinical trials verify the findings, this research may
ultimately prove beneficial to the estimated 16 million people in the U.S. and
millions more worldwide who have diabetes.  People with diabetes are at
greatly increased risk of developing a wide range of blood vessel
complications, including diabetic eye disease called diabetic retinopathy,
which can cause sight loss and even blindness.  According to the Centers for
Disease Control and Prevention, diabetic retinopathy causes 12,000 to 24,000
new cases of blindness each year in the United States.

The results of the Phase I clinical trial of LY333531 will be announced by
Joslin researcher Lloyd P. Aiello, M.D., Ph.D., tomorrow, Oct. 23, at an
international research conference in Boston marking Joslin's Centennial. The
talk will be presented Friday at 4-5 p.m. in the Seaport Ballroom of the
Seaport Hotel at Boston's World Trade Center.

Dr. Aiello will report on the month-long study of 29 people with type 1 and
type 2 diabetes who were treated with a synthesized inhibitor of a protein
called protein kinase C-beta (PKC b). The researchers found that the synthetic
compound, called LY333531, was safe, well tolerated and normalized some blood
vessel abnormalities in the eyes of the study participants.  The particular
abnormalities measured were mean retinal circulation time and retinal blood
flow, both of which are abnormal in people with early stages of developing
diabetic eye disease.

"These findings support proceeding with the larger ongoing clinical trials
being performed at the Joslin and over 30 other sites throughout the world,"
said Dr. Aiello, an Investigator in Joslin's Vascular Cell Biology Section, an
Assistant Professor of Ophthalmology at Harvard Medical School and study
chairman of the ongoing international trials.  Other Joslin researchers
participating in the study include Sven-Eric Bursell, Ph.D., an Investigator
in the Section on Eye Research at Joslin and an Assistant Professor in
Ophthalmology at Harvard Medical School, and Lloyd M. Aiello, M.D., Head of
Joslin's Section on Eye Research, Director of the Beetham Eye Institute at
Joslin and Associate Clinical Professor of Ophthalmology at Harvard Medical
School.  D. Kirk Ways, M.D., of Lilly Research Laboratories was also a
critical member of the study development team.

Researchers have known for some time that the activation of PKC b by elevated
blood sugar in people with diabetes helps trigger vascular disease. Many of
these studies were performed by George L. King, M.D., of Joslin and Professor
of Medicine, Harvard Medical School, who has been a pioneer in the study of
PKC and diabetes-associated complications and was instrumental in the drug's
development.  Previous studies conducted by the Joslin researchers showed that
the PKC b inhibitor was beneficial for diabetes-associated complications in
the eyes, kidneys and heart in animals.  In addition, supporting data from
other laboratories will be presented showing that inhibition of PKC beta
prevents nerve disease in diabetic rats.  Researchers at Eli Lilly and Company
are sponsoring the studies to bring LY333531 to market as a drug to treat or
prevent diabetes-related vascular problems if the substance proves successful
in humans.

In the double-masked, randomized multiple dose, month-long study, 29 patients
with type 1 or type 2 diabetes received either LY333531 administered orally at
varying doses or a placebo.  The researchers found that blood flow in the
retina of the eye and the time the blood took to flow through the retina
improved in those who received the agent.

The researchers found no significant effect on blood sugar levels.  "The data
indicate that LY333531 was safe under these conditions and well tolerated in
these patients over the period of one month and was not associated with overt
toxicity or an excess of adverse events," Dr. Aiello said.  "The ability of
the substance to prevent or reverse vascular dysfunction in the retina of the
eye without affecting blood glucose levels suggests that the drug is reaching
the eye and may thus eventually prove to be effective.  Studies to determine
if the drug can reduce actual eye complications in patients with diabetes are

"The potential applications for this finding are sizable," notes Dr. Aiello.
"This compound represents a new class of drugs that may be able to prevent
many of the complications in diabetes patients, such as those observed in the
eye, kidney, nerves and heart."  This is the first compound of this type that
has been shown to inhibit PKC b action when administered orally in people.
Since PKC b activation has been found in many disease states, the agent one
day may be used to treat such other illnesses as arthritis, heart disease,
cancer and Alzheimer's disease.

In previously published studies headed by Joslin researcher George L. King,
M.D., the PKC b inhibitor was shown to be particularly effective in preventing
blood vessel problems related to kidney complications and heart failure in

Established in 1898, Joslin Diabetes Center is an internationally recognized
diabetes treatment, research and education institution affiliated with Harvard
Medical School.  Headquartered in Boston, Joslin has satellite treatment
centers in the Boston area, as well as affiliated diabetes treatment
facilities at prestigious hospitals from New York to Hawaii.

SOURCE  Joslin Diabetes Center  

CO:  Joslin Diabetes Center

ST:  Massachusetts



10/22/98 13:18 EDT http://www.prnewswire.com

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