Clinical proof-of-concept study will also evaluate whether
metreleptin can reduce the amount of insulin needed by patients
with type 1 diabetes
NEW YORK and SAN DIEGO, Nov. 16,
2010 /PRNewswire-USNewswire/ -- The Juvenile Diabetes
Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) announced today that they entered into a research
collaboration agreement to provide financial support for a clinical
proof-of-concept study to investigate the effects of metreleptin,
an analog of the human hormone leptin, in patients with type 1
diabetes. Researchers at The University of
Texas (UT) Southwestern Medical
Center will conduct the study.
Prior studies at UT Southwestern conducted in animal models with
type 1 diabetes showed an improvement in blood glucose, blood fats,
and cholesterol following administration of the hormone. The
clinical study will help to determine if similar improvements in
glucose, and reduction of the amount of insulin required, can be
achieved in people with type 1 diabetes. Leptin is a hormone
secreted by fat cells that plays a fundamental role in the
regulation of glucose metabolism.
"Better blood glucose control means healthier living for people
with type 1 diabetes," said Aaron
Kowalski, Ph.D., Assistant Vice President of Treatment
Therapies at JDRF. "If effective in humans, metreleptin, when used
with insulin, could change the way people manage their disease.
Less insulin usage and fewer low blood sugar episodes would
represent a significant improvement in quality of life for certain
people living with type 1 diabetes today."
"Building on our development experience with type 1 diabetes, we
continually look for ways to unleash the potential of peptide and
protein science to help the millions of patients with diabetes
better manage their disease," said David
Maggs, MD, MRCP, Vice President for R&D Strategic
Relations at Amylin. "We are pleased to partner on this important
research program with an organization that shares our passion for
investigating the potential promise of new and innovative
therapies."
The research collaboration agreement between JDRF and Amylin is
part of JDRF's Industry Discovery and Development Partnership
(IDDP) program through which JDRF partners with pharmaceutical,
biotechnology, and medical device companies focused on the
discovery, development, and delivery of therapeutics and devices
for type 1 diabetes and its complications. Since the IDDP program
was established in 2004, JDRF has funded 35 partnerships with 29
companies and committed approximately $71
million to accelerate research that will lead to better
treatments and a cure for type 1 diabetes.
About the Study
This proof-of-concept clinical study will investigate whether
treatment with metreleptin can help improve blood sugar control and
decrease the daily doses of insulin required in patients with type
1 diabetes. This is the first clinical study evaluating metreleptin
treatment in patients with type 1 diabetes. The study will also
evaluate whether treatment with metreleptin can improve variability
in blood sugar levels, including the propensity for hypoglycemia
(low blood sugar levels), which affects many people with type 1
diabetes.
Conducted by researchers at UT Southwestern in Dallas, Texas, including Roger Unger, MD, professor of internal medicine,
the study will enroll 12 to 15 patients with type 1 diabetes.
Patients will add metreleptin twice a day to their usual insulin
therapy over a five-month period. The insulin dosage will gradually
be reduced to further characterize the effect of metreleptin on
overall blood glucose. This study will build on recent preclinical
findings by Dr. Unger and his team that showed leptin
administration improved blood glucose levels, blood fats, and
cholesterol in animal models of type 1 diabetes.
Abhimanyu Garg, MD and
Greg Clark, MD will conduct the
clinical arm of the project. Additional information about UT
Southwestern can be found at www.utsouthwestern.edu.
"We were highly encouraged by the results of our study of leptin
in animal models and look forward to learning whether using
metreleptin with insulin yields similar results in humans," said
Dr. Unger. "Achieving a substantial reduction in insulin doses and
lowering the risk of low blood glucose levels could enhance the
quality of life for people with type 1 diabetes."
About Leptin
Leptin, a fat cell hormone that plays a key role in regulating
metabolism, was first discovered in 1994 by Dr. Jeffrey Friedman of The
Rockefeller University in New
York. Dr. Friedman has won numerous awards during his career
and recently won the 2010 Lasker Award in basic medical research
for his work. Metreleptin, an analog of human leptin, has been
studied as a potential treatment for obesity, type 2 diabetes, and
severe lipodystrophy.
About JDRF
JDRF is a leader in setting the agenda for diabetes research
worldwide, and is the largest charitable funder of and advocate for
type 1 diabetes research. The mission of JDRF is to find a cure for
diabetes and its complications through the support of research.
Type 1 diabetes is an autoimmune disease that strikes children and
adults suddenly, and can be fatal. Until a cure is found, people
with type 1 diabetes have to test their blood sugar and give
themselves insulin injections multiple times or use a pump - each
day, every day of their lives. And even with that intensive care,
insulin is not a cure for diabetes, nor does it prevent its
potential complications, which may include kidney failure,
blindness, heart disease, stroke, and amputation. To help improve
the lives of people with type 1 diabetes while working toward a
cure, one of JDRF's research goals is to support research to
develop products that can dramatically improve blood glucose
control in people with type 1 diabetes so they can live healthier
lives with less risk of developing disease-related complications.
Since its founding in 1970 by parents of children with type 1
diabetes, JDRF has awarded more than $1.5
billion to diabetes research, including more than
$107 million last year. More than 80
percent of JDRF's expenditures directly support research and
research-related education. For more information, please visit
www.jdrf.org.
About Amylin Pharmaceuticals, Inc.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN®(pramlintide acetate) injection and BYETTA® (exenatide)
injection. Amylin's research and development activities leverage
the Company's expertise in metabolism to develop potential
therapies to treat diabetes and obesity. Amylin is headquartered in
San Diego, Calif. Further
information on Amylin Pharmaceuticals is available at
http://www.amylin.com.
This press release contains forward-looking statements about
Amylin, which involve risks and uncertainties. Amylin's actual
results could differ materially from those discussed herein due to
a number of risks and uncertainties, including that clinical trials
or studies, including the metreleptin clinical study mentioned in
this press release, may not start when planned, confirm previous
results, be predictive of real world use, or achieve intended
clinical endpoints; preclinical studies, including the preclinical
study mentioned in this press release, may not be predictive; our
product candidates may not receive regulatory approval; and
inherent scientific, regulatory and other risks in the drug
development and commercialization process; SYMLIN and the
SymlinPen, and the revenues generated from these products, may be
affected by competition, unexpected new data, technical or safety
issues, or manufacturing and supply issues. Commercial and
government reimbursement and pricing decisions and the pace of
market acceptance may also affect the potential for SYMLIN and the
SymlinPen®. These and additional risks and uncertainties are
described more fully in Amylin's most recently filed SEC documents,
including its Form 10-Q. Amylin undertakes no duty to update these
forward-looking statements.
SOURCE Juvenile Diabetes Research Foundation