Navigation Links
Diamyd Gets Authorization to Begin Phase III Study in the US
Date:3/14/2008

STOCKHOLM, March 14 /PRNewswire-FirstCall/ -- Diamyd Medical AB (http://www.omxgroup.com, ticker: DIAM B; http://www.otcqx.com, ticker DMYDY). The FDA has given Diamyd Medical permission to start a Phase III clinical study in type 1 diabetes patients in the US with the therapeutic diabetes vaccine Diamyd(R).

(Logo: http://www.newscom.com/cgi-bin/prnh/20080314/297194 )

"We are eager to start this study and to be able to offer this promising drug to our newly diagnosed type 1 diabetes patients", says Professor Jerry Palmer, University of Washington in Seattle, USA, who will be the Lead Investigator for the US study.

"We are extremely pleased with this progress," says Elisabeth Lindner, President and CEO of Diamyd Medical. "Over the past months we have received dozens of patient inquiries with requests to participate in our Phase III type 1 diabetes studies in the US and in Europe. It is very satisfying to be able to start the studies now."

The US Phase III study will enroll 306 new-onset type 1 diabetes patients, who are within 3 months of diagnosis. Results of the study will be analyzed 15 months after all patients have been enrolled. A parallel Phase III study is planned to be conducted in Europe and together, pending a positive outcome of the trials, these pivotal studies can be used for market registration of the drug.

In a previous Phase II study in young type 1 diabetes patients, Diamyd(R) showed efficacy in preserving the patients' own insulin producing capacity for at least 30 months. No safety concerns have to date been reported in any clinical study with Diamyd(R).

Company website: http://www.diamyd.com

Diamyd Medical AB (publ). Linnegatan 89 B, SE-115 23 Stockholm, Sweden

Disclaimer: This document contains certain statements relating to the progress, timing and completion of our research, development and clinical trials. These statements can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Diamyd Medical undertakes no obligation to publicly update such statements, whether because of new information, future events or otherwise, nor does Diamyd Medical give any guarantees that the statements, given or implied, are correct. This document is a translation from the Swedish original. No guarantees are made that the translation is free from errors.


'/>"/>
SOURCE Diamyd Medical AB (publ)
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
2. Techne Corporation Announces Share Repurchase Authorization
3. Cell Therapeutics, Inc. (CTI) to Submit Marketing Authorization Application for XYOTAX(TM) for First-line Non-small Cell Lung Cancer Ahead of Schedule
4. Athersys and Angiotech announce authorization of Phase I intramyocardial stem cell U.S. clinical trial in acute myocardial infarction
5. Cell Therapeutics, Inc. Announces Authorization to Publish Italian Listing Prospectus
6. EMEA Accepts for Review Vidaza(R) Marketing Authorization Application for Higher-Risk Myelodysplastic Syndromes
7. ZARS Pharma Announces Marketing Authorization of Rapydan(R) in Europe
8. ExonHit Therapeutics: Allergan and ExonHits First Collaboration Compound to Begin Human Clinical Trials
9. DOV Pharmaceutical, Inc. Begins Trading on OTC Bulletin Board
10. Genzyme Begins Major Expansion of Boston Manufacturing Facility
11. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)...   EpiBiome , a precision microbiome engineering company, ... financing from Silicon Valley Bank (SVB). The financing will ... its drug development efforts, as well as purchase additional ... has been an incredible strategic partner to us – ... would provide," said Dr. Aeron Tynes Hammack , ...
(Date:6/23/2016)... ... , ... STACS DNA Inc., the sample tracking software company, today announced that ... joined STACS DNA as a Field Application Specialist. , “I am thrilled that ... of STACS DNA. “In further expanding our capacity as a scientific integrator, Hays brings ...
(Date:6/23/2016)... Ky. , June 23, 2016 ... two Phase 1 clinical trials of its complement ... placebo-controlled, single and multiple ascending dose studies designed ... pharmacodynamics (PD) of subcutaneous injection in healthy adult ... subcutaneously (SC) either as a single dose (ranging ...
(Date:6/23/2016)... June 23, 2016 ... 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 Published recently ... peer-reviewed journal from touchONCOLOGY, Andrew D Zelenetz ... of cancer care is placing an increasing burden ... expensive biologic therapies. With the patents on many ...
Breaking Biology Technology:
(Date:4/26/2016)... BANGALORE, India and LONDON ... Infosys Finacle, part of EdgeVerve Systems, a ... ), and Onegini today announced a partnership to ... banking solutions.      (Logo: http://photos.prnewswire.com/prnh/20151104/283829LOGO ... banks to provide their customers enhanced security to ...
(Date:4/19/2016)... April 20, 2016 The new ... a compact web-based "all-in-one" system solution for all door ... reader or the door interface with integration authorization management ... control systems. The minimal dimensions of the access control ... the building installations offer considerable freedom of design with ...
(Date:4/15/2016)... 15, 2016 Research and ... Biometrics Market 2016-2020,"  report to their offering.  , ... , ,The global gait biometrics market is expected ... the period 2016-2020. Gait analysis generates ... be used to compute factors that are not ...
Breaking Biology News(10 mins):