Healthcare Industry News: Diamyd Medical
News Release - March 10, 2010
Diamyd Medical: Diamyd US Phase III Study Well under Way
STOCKHOLM--(HSMN NewsFeed)--Diamyd Medical (STO:DIAMB)(Pink Sheets:DMYDY ) announces today that one hundred study participants have been included in the ongoing US Phase III study, DiaPrevent. The global Phase III program with the company’s lead drug candidate Diamyd® has thereby enrolled more than 430 children newly diagnosed with type 1 diabetes in Europe and the USA.One hundred patients are now enrolled in the company’s US Phase III study called DiaPrevent at 33 diabetes centers throughout the USA and more sites will be added. The study will include 320 children and adolescents between 10 and 20 years of age, recently diagnosed with type 1 diabetes.
“After FDA’s approval to include children down to 10 years of age, which is enabling us to add pediatric sites, the recruitment rate has shown a remarkable increase. Numerous sites have been added with more to come. Last month one new patient per day received their first injection and the recruitment rate is accelerating," says Elisabeth Lindner, CEO and President of Diamyd Medical.
More than 430 children have received Diamyd® or placebo in the global Phase III program. To date, no serious side effects related to the drug have been reported, which supports the strong safety profile seen in previous studies with Diamyd®.
The global Phase III program aims to investigate whether Diamyd® can halt or slow the autoimmune destruction of beta cells in type 1 diabetes, preserving the body's own ability to control blood sugar levels. An improved blood sugar control reduces the risk for both acute and long-term diabetes complications. Diamyd® has been shown, in Phase II studies, to preserve the remaining beta cell function in children and adolescents recently diagnosed with type 1 diabetes.
The DiaPrevent study centers were opened for children as young as 10 years of age during autumn 2009 after previously having included only age 16-20 years. New study sites are added as they receive ethics board approvals.
The parallel European Phase III study was fully recruited in November 2009 and results are expected during spring 2011.
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).
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.
Tel: +46 (0)8 6610026, Fax: +46 (0)8 661 63 68 E-mail: info@diamyd.com.
Source: Diamyd Medical
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