Press Release, March 11, 2009
TrialNet Centers Begin Diamyd® Vaccine Study for Recent-Onset Type 1 Diabetes
Diamyd Medical announces today that Type 1 Diabetes TrialNet, a clinical network
funded by the National Institutes of Health to prevent and treat newly diagnosed
type 1 diabetes, has started recruiting patients for a clinical trial testing
the Diamyd®-vaccine's therapeutic benefit in individuals with recent-onset type
1 diabetes.
The study will, as previously announced, assess the vaccine's ability to protect
and preserve insulin-secreting beta cells, which are destroyed by the body's
immune system in type 1 diabetes. Under the terms of the agreement with the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a part
of the National Institutes of Health, Diamyd Medical has supplied Diamyd®
(GAD-alum) and placebo material for the trial.
“We are pleased to announce the launch of this trial, which will employ
state-of-the-art technology to investigate the vaccine's modulation of the
immune system to induce immune tolerance in type 1 diabetes. We look forward to
studying the vaccine's effect and mechanism of action at TrialNet's 15 clinical
centers in North America,” says Dr. Jay Skyler, TrialNet Chair and Professor of
Endocrinology, Diabetes, and Metabolism at the University of Miami.
“This is good news,” notes Elisabeth Lindner, President and CEO of Diamyd
Medical. “It is of great value that key leading diabetes experts and thought
leaders now will get first hand experience with the Diamyd® vaccine prior to
market introduction.”
TrialNet centers are conducting the Phase II study in 126 patients with type 1
diabetes diagnosed in the previous three months. In the study, patients will
receive three injections of Diamyd®, two injections of Diamyd® plus one
injection of placebo, or three injections of placebo. The study will be
conducted at the following Type 1 Diabetes TrialNet centers in North America:
Joslin Diabetes Center, Massachusetts (Principal Investigator (PI) - Dr. Orban);
Yale University School of Medicine, Connecticut (PI - Dr. Herold);
Columbia University, New York (PI -Dr. Goland);
Children's Hospital of Pittsburgh, Pennsylvania (PI -Dr. Becker);
University of Florida, Florida (PI -Dr. Schatz);
University of Miami, Florida (PI -Dr. Marks);
Indiana University, Indiana (PI -Dr. Rodriguez);
Barbara Davis Center for Childhood Diabetes, Colorado (PI -Dr. Gottlieb);
University of Texas, Texas (PI -Dr. Raskin);
University of California San Francisco, California (PI -Dr. Gitelman);
Stanford University, California (PI -Dr. Wilson);
Children's Hospital of Los Angeles, California (PI -Dr. Kaufman);
University of Minnesota, Minnesota (PI -Dr. Moran);
Benaroya Research Institute, Washington (PI -Dr. Greenbaum);
Hospital for Sick Children, University of Toronto, Canada (PI -Dr. Wherrett).
For more information about TrialNet studies, see www.DiabetesTrialNet.org or
call 1-800-HALT-DM1 (+1-800-425-8361) in the U.S.
Type 1 Diabetes TrialNet is an international consortium dedicated to advancing
the science of prevention and early treatment of type 1 diabetes. TrialNet is a
worldwide network of 18 clinical centers and more than 150 additional affiliated
centers participating as collaborating clinical sites. TrialNet is supported by
the United States National Institutes of Health, Juvenile Diabetes Research
Foundation International, and the American Diabetes Association.
In addition to the TrialNet study, the Diamyd® vaccine is also being studied in
several other clinical trials funded by third parties. These include a U.S.
Phase II study combining Diamyd® with beta cell regenerative agents in 84
patients (funded by the National Institutes of Health); a Norwegian Phase II
characterization and prevention study in 150 participants; and a Swedish Phase
II prevention study in 50 children at high risk for developing type 1 diabetes.
Type 1 diabetes is an autoimmune disease in which the insulin-producing cells of
the pancreas are attacked and destroyed by the patient's own immune system. In
an earlier Phase II study, the Diamyd® vaccine was shown to intervene in this
autoimmune process and preserve patients' insulin producing capacity.
(Ludvigsson et al, New England Journal of Medicine, October 2008). The company's
own Phase III studies with Diamyd® are ongoing in the U.S. and in nine countries
in Europe.
For more information, please contact:
Elisabeth Lindner, President and CEO Diamyd Medical AB (publ.),
elisabeth.lindner@diamyd.com
Phone: +46-8-661 00 26
For pictures and press material, please contact:
Sonja Catani, Chief Communications Officer Diamyd Medical AB (publ.),
sonja.catani@diamyd.com
Phone: +46-8-661 00 26
This information is disclosed in accordance with the Securities Markets Act, the
Financial Instruments Trading Act or demands made in the exchange rules.
Diamyd Medical is a Swedish biopharmaceutical company focusing on development of
pharmaceuticals for treatment of autoimmune diabetes and its complications. The
company's most advanced project is the GAD-based drug Diamyd® for type 1
diabetes for which Phase III trials are ongoing in both the US and Europe.
Furthermore, the company has ongoing clinical studies within chronic pain, using
its Nerve Targeting Drug Delivery System (NTDDS). The company has also
out-licensed the use of GAD for the treatment of Parkinson's disease.
Diamyd Medical has offices in Sweden and in the US. The share is quoted on the
OMX Stockholm Nordic Exchange (ticker: DIAM B) and on OTCQX in the US (ticker:
DMYDY) administered by the Pink Sheets and the Bank of New York (PAL). Further
information is available on the company's web site: www.diamyd.com.
Diamyd Medical AB (publ.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8
661 63 68
E-mail: info@diamyd.com. VATno: SE556530-142001.
(www.omxnordicexchange.com ticker: DIAM B; www.otcqx.com ticker: DMYDY)
