Diamyd Medical reports today that the United States Food and Drug
Administration
(FDA) has approved the experimental use of Diamyd® vaccine in
children as young
as 3 years of age in the TrialNet GAD study, enrolling 126
new onset type 1
diabetes patients in North America.
The TrialNet GAD study, conducted by an
international network of leading
pediatric and adult endocrinologists
and immunologists, has previously enrolled
new onset type 1 diabetes patients
from 16 to 45 years of age but is now allowed
by the FDA to enroll and
administer the Diamyd® vaccine to children as young as
3 years of age.
“This is very
encouraging news,” says Elisabeth Lindner, CEO and President at
Diamyd
Medical. “The approval to enroll small children in the TrialNet study is
based on an FDA review of safety data from our ongoing Phase III trials and
further supports that the Diamyd® vaccine's safety profile is strong.”
The TrialNet study is a double-blind, randomized, placebo-controlled
trial,
which aims to enroll a total of 126 new onset type 1 diabetes
patients at 16
TrialNet sites in the US and Canada. One third of the
participants will receive
3 injections with the Diamyd® vaccine, one third
will receive 2 injections with
the Diamyd® vaccine and one third will receive
placebo (inactive drug). The
purpose of the study is to determine whether
the Diamyd® vaccine will preserve
the body's ability to make its own insulin
to help control blood sugar.
The trial also includes extensive
immunological studies to clarify the mechanism
of action of Diamyd® and to
evaluate the correlation between the clinical and
immunological outcomes of
Diamyd® treatment in new onset type 1 diabetes
patients.
Diamyd Medical has
approved the protocol and has executed a Clinical Trial
Agreement with
the National Institute of Diabetes and Digestive and Kidney
Diseases,
part of the US National Institutes of Health, to supply
clinical-grade
material (i.e. Diamyd® and placebo) for this trial. TrialNet is
sponsored by the
National Institutes of Health and supported by Juvenile
Diabetes Research
Foundation International and the American Diabetes
Association.
For more information, please contact:
Elisabeth Lindner, President and CEO
Diamyd Medical AB (publ.)
Phone: +46 8 661 0026
For pictures and press
material, please contact:
Andreas Ericsson,
Diamyd Medical AB (publ.)
andreas.ericsson@diamyd.com
Phone: +46 8 661 0026
About Diamyd Medical
Diamyd Medical is a Swedish diabetes company focusing on the
development of
pharmaceuticals for the treatment of autoimmune diabetes
and its complications.
The company's most advanced project is the GAD-based
drug Diamyd® for type 1
diabetes. Phase III trials for this drug are in
progress in both Europe and the
US. In addition, the company has initiated
clinical studies in the US in the
area of 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. The
company currently has three clinical-phase products.
Diamyd Medical has
offices in Sweden and in the US. Shares are listed on Nasdaq
OMX in Stockholm
(ticker: DIAM B) and on OTCQX in the US (ticker: DMYDY)
administered
by the Pink OTC Markets and the Bank of New York Mellon (PAL).
Further
information is available on the company's website: www.diamyd.com.
This information is disclosed in accordance with the Swedish Securities
Markets
Act, the Swedish Financial Instruments Trading Act, or the
requirements stated
in the listing agreements.
Diamyd Medical AB (publ.)
Linnégatan 89 B, SE-115 23 Stockholm, Sweden.
Tel: +46 (0)8 6610026, Fax: +46
(0)8 661 63 68
E-mail: info@diamyd.com. VAT no:
SE556530-142001.
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