Navigation Links
Diamyd(R) Phase III Study Approved for Younger Patients in the US

STOCKHOLM, June 8 /PRNewswire-FirstCall/ -- Diamyd Medical reported today that the company has received approval from the US Food and Drug Administration (FDA) to include children with type 1 diabetes from 10 years of age in the company's Phase III study with the diabetes vaccine Diamyd(R).

(Logo: )

Diamyd Medical is conducting two parallel phase III studies, one in Europe and one in the USA, comprising a total of 640 patients. The objective of the studies is to evaluate the ability of the Diamyd(R) vaccine to halt or delay the autoimmune attack on the body's insulin-producing cells, thereby preserving the body's own ability to produce insulin in children and adolescents with recent-onset type 1 diabetes.

The European study, which is being conducted in nine countries, is approved for patients between 10 and 20 years of age, whilst the US study so far has been approved only for patients 16 to 20 years, an age group with few recent-onset type 1 diabetes patients. The company is, with the new approval, allowed to begin enrollment of children from 10 years of age in the US phase III study.

"This is a big step forward giving us the opportunity to accelerate patient recruitment in the US," says Elisabeth Lindner, President and CEO of Diamyd Medical. "We are pleased that the approval comes now in connection with the world's largest diabetes conference, the ADA's 69th Scientific Sessions, which is currently ongoing in New Orleans."

The company will now, in pace with Institutional Review Board (IRB) approvals in USA, increase the number of American pediatric clinics in the study. The application for market approval is, as before, planned for spring 2011.

Diamyd Medical is represented at booth #2431 at the ADA's 69th Scientific Sessions in New Orleans, USA.

About Diamyd Medical

Diamyd Medical is a Swedish biopharmaceutical 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(R) for type 1 diabetes. Phase III trials for this drug are in progress in both Europe and the US. In addition, the company has started 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 has currently three clinical-phase products.

Diamyd Medical has offices in Sweden and in the US. Shares are listed on the Nasdaq OMX 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 website:

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. <start table>

    For additional information, please contact:
    Elisabeth Lindner,
    President and CEO Diamyd Medical AB (publ.),
    Tel: +46(0)8-661-00-26.

    For pictures and press material, please contact:
    Alexandra Fleetwood,
    Director Communications Diamyd Medical AB (publ.),,
    Tel: +46(0)8-661-00-26. <end table>

SOURCE Diamyd Medical AB (publ)
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients
2. Optimer Pharmaceuticals Announces Lower Recurrence Rates for Fidaxomicin Versus Vancocin(R) in Subgroup Analyses from Its Phase 3 Study for the Treatment of CDI
3. Raptor Pharmaceuticals Doses First Patient in Phase 2b Clinical Trial of DR Cysteamine for Cystinosis
4. Peregrine Pharmaceuticals Presents Promising Data From Its Phase II Bavituximab Breast Cancer Trial at 2009 ASCO Annual Meeting
5. Mersana Reports Preliminary Phase 1 Results of XMT-1001 in Patients with Advanced Solid Tumors
6. Valeant Pharmaceuticals Reports Encouraging Final Results With Taribavirin Phase IIb Study
7. Oncolytics Biotech(R) Inc. Collaborators Present Positive Phase II Sarcoma Trial Results at ASCO Annual Meeting
8. Micromet Presents Update at ASCO 2009 on a Phase 1b Combination Study of Adecatumumab and Docetaxel
9. OncoGenex Pharmaceuticals Announces OGX-011 Treatment Provides Survival Benefit in Randomized Phase 2 Trial in Advanced Metastatic Prostate Cancer
10. OncoGenex Pharmaceuticals Announces OGX-427 Treatment Demonstrates Safety, Evidence of Declines in Circulating Tumor Cells and Reductions in Tumor Markers in a Phase 1 Cancer Trial
11. Oral VDA CYT997 - Phase I Clinical Trial Presentation at ASCO
Post Your Comments:
(Date:11/27/2015)... 2015 --> ... companion diagnostics is one of the major ... pharmaceutical companies and diagnostic manufacturers working together ... . --> ... global cancer biomarkers market spread across 89 ...
(Date:11/25/2015)... 2015 --> ... - 2020 report analyzes that automating biobanking workflow ... in long-term samples, minimizing manual errors, improving the ... manual errors such as mislabeling or inaccurate sample ... plays a vital role in blood fractionation, DNA ...
(Date:11/25/2015)... , November 25, 2015 ... cat and human plaque and pave the way for more ... problems in cats     --> ... most commonly diagnosed health problems in cats, yet relatively little ... now. Two collaborative studies have been conducted by researchers from ...
(Date:11/25/2015)... CITY , Nov. 25, 2015 /PRNewswire/ - Aeterna ... affirms that its business and prospects remain fundamentally ... , Zoptrex™ (zoptarelin doxorubicin) recently received DSMB recommendation ... to completion following review of the final interim ... Phase 2 Primary Endpoint in men with heavily ...
Breaking Biology Technology:
(Date:11/4/2015)... , November 4, 2015 ... new market report published by Transparency Market Research "Home Security ... Trends and Forecast 2015 - 2022", the global home security ... 30.3 bn by 2022. The market is estimated to ... period from 2015 to 2022. Rising security needs among ...
(Date:10/29/2015)... 2015  Rubicon Genomics, Inc., today announced an ... its DNA library preparation products, including the ThruPLEX ... Plasma-seq kit. ThruPLEX Plasma-seq has been optimized for ... libraries for liquid biopsies--the analysis of cell-free circulating ... in cancer and other conditions. Eurofins Scientific is ...
(Date:10/27/2015)... Germany , October 27, 2015 ... SMI,s Automated Semantic Gaze Mapping technology (ASGM) automatically maps ... SMI,s Eye Tracking Glasses , so that they ... BeGaze. --> Munich, Germany , ... (ASGM) automatically maps data from mobile eye tracking videos ...
Breaking Biology News(10 mins):