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Prevention Study with Diamyd’s Diabetes Vaccine Fully Recruited

January 9, 2012


Regulatory News:

A total of 50 children aged four and older with a high risk of
developing type 1 diabetes have been enrolled in a researcher-initiated
Phase II study, DiAPREV-IT, with Diamyd Medical’s diabetes vaccine
Diamyd®. The study is thus fully recruited. The purpose of the study is
to evaluate whether preventive treatment with Diamyd® can delay or halt
the progression of the disease so that the children do not develop
clinical symptoms of type 1 diabetes.

The children enrolled in the study are healthy, but have all been found
to have an ongoing autoimmune process, where their blood
sugar-regulating beta cells in the pancreas are being destroyed by their
own immune system. If the destruction is not stopped, it can with time
lead to type 1 diabetes. Preventive treatment with Diamyd® is intended
to intervene in the autoimmune process at an early stage, and thus
prevent the disease from developing. Today there is no treatment that
can halt the progress of disease in type 1 diabetes.

“It is very exciting to follow the children in this prevention study,
which is the first of its kind,” says Peter Zerhouni, President and CEO
of Diamyd Medical. “This study provides valuable information that can
form the basis for larger prevention studies. If it turns out that
preventive treatment with our diabetes vaccine reduces the risk of
developing type 1 diabetes in these children it would be a great step
forward in diabetes research.”

The study is being conducted by a research group at Lund University and
is led by Dr. Helena Elding Larsson, a pediatrician in Malmö and
researcher at Lund University. The study is funded by research grants,
but Diamyd Medical has participated in the design of the study and can
utilize the study results.

“I think there is a good chance that the diabetes vaccine can have
effect in the preventive treatment of children who have not yet been
diagnosed with type 1 diabetes,” says Helena Elding Larsson. “In
DiAPREV-IT, we vaccinate the children early in the disease process when
they still have many beta cells left to save and the disease process is
not as aggressive as in newly diagnosed, which should increase the
chance that the vaccine will have an effect.”

DiAPREV-IT, which was started in 2009, is a double-blind,
placebo-controlled Phase II study including a total of 50 children aged
four and older who through analysis of diabetes markers, so-called
auto-antibodies, in the blood are demonstrated to be at high risk of
developing type 1 diabetes. Study participants have auto-antibodies
against GAD65 and at least one other auto-antibody. Half of the children
receive two injections of Diamyd®, and the remaining half receive
placebo (inactive substance). The children will be monitored for a total
of five years by means of sampling and glucose tolerance tests to
evaluate the beta cell function, a measure of the body’s own ability to
regulate blood sugar. The first results are expected to be compiled
three years after the last participant is enrolled, and can thereby be
presented in 2015.

Diamyd® has previously been evaluated in a Phase III study of children
already diagnosed with type 1 diabetes. The Phase III study did not met
the primary efficacy endpoint of preserving beta cell function. Safety
data from the study showed that Diamyd® was well tolerated, as
demonstrated by a similar number of adverse events reported across all
treatment groups.

About Diamyd Medical Diamyd Medical is a Swedish biotech company
focusing on the development of pharmaceuticals for the treatment of
pain, neuropathy and diabetes. The portfolio of development projects for
the treatment of chronic pain and neuropathy uses the Company’s patented
NTDDS (Nerve Targeting Drug Delivery System) platform to administer
therapeutic agents directly to the nervous system. The development
project within the area of diabetes consists of the protein GAD65 for
the treatment and prevention of autoimmune diabetes.

Diamyd Medical has offices in Sweden and in the US. Shares are listed on
Nasdaq OMX (segment Small Cap) in Stockholm (ticker: DIAM B) and on
OTCQX in the US (ticker: ticker:Other OTC:DMYDY.PK – News) 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) Karlavägen 108, SE-115 26 Stockholm, Sweden.
Phone: +46 8 6610026, Fax: +46 8 661 63 68
E-mail: info@diamyd.com.
Reg. no: 556530-1420

This information was brought to you by Cision http://www.cisionwire.com

Article source: http://finance.yahoo.com/news/prevention-study-diamyds-diabetes-vaccine-075000035.html


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