- Diamyd Medical
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Diamyd Medical AB (OMX: DIAM B) is a Swedish medical research company, listed on the Stockholm Stock Exchange. Diamyd's research utilises two different platform technologies. One is based on the GAD65 molecule, which is used in a vaccine that has proven effective in delaying the destruction of beta cells associated with type 1 diabetes, the other on a system to deliver substances directly to nerve cells. The use of GAD65 for therapeutic purposes is licensed from the University of California, Los Angeles. In March, 2008 Diamyd's application for a phase III trial in the United States was approved by the U.S. Food and Drug Administration. The company will perform a parallel phase III trial in Europe.
Contents
Product portfolio
Diamyd, a (GAD65 based, type 1 diabetes vaccine). Injections with GAD65, an autoantigen involved in type 1 diabetes, has in clinical trials delayed the destruction of beta cells for at least 30 months, without serious adverse effects.[1] Patients treated with the substance showed higher levels of regulatory cytokines, thought to protect the beta cells.[2] Phase III trials are under way in the USA and in Europe.[3][4] Future applications can include latent autoimmune diabetes[5] and prevention of type 1 diabetes.[6] Two prevention studies will start in 2009.[7][8]
NTDDS (Nerve Targeting Drug Delivery System) - A viral delivery system of proteins to nervous tissue (Nerve Targeted Drug Delivery System, NTDDS) that can be used e.g. against chronic pain. A phase I trial has shown positive results.[9]
Licences
NeuroLogix has a licensed the use of GAD65 from Diamyd Medical for Parkinson's disease. Phase I and II trials have shown positive results.[10][11]
Investments
Diamyd owns substantial shares of Mercodia, a company manufacturing diagnostic products for e.g. diabetes and Protein Sciences Corporation, the vaccine company which produces the Diamyd GAD65 vaccine.
Ongoing trials
Phase III trial in USA [12]
Phase III trial in Europe [13]
Phase II trial sponsored by NIDDK [14]The two phase III trials performed by Diamyd Medical will consist of 306 newly diagnosed Type 1 Diabetes patients each. 102 will receive two injections of the GAD65 vaccine, 102 will receive four injections and the last 102 patients will be a control group receiving placebo.
Finished trials
Phase II trial in Europe[3][15]
Phase II LADA trial in Europe (aborted) [16][17]External links
References
- ^ Presentation from the Extra General Shareholders Meeting on March 10, 2008: In the treatment of Diabetes and Diabetes related complications
- ^ New England Journal of Medicine: GAD Treatment and Insulin Secretion in Recent-Onset Type 1 Diabetes
- ^ a b Further Evidence for Lasting Immunological Efficacy of Diamyd Diabetes Vaccine
- ^ Diamyd Announces Completion of Type 1 Diabetes Vaccine Trial with Long Term Efficcacy Demonstrated at 30 Months
- ^ Beta cell function and metabolic control during two years of follow-up after GAD65 dose-escalation immunomodulation in adult-onset autoimmune diabetes
- ^ New England Journal of Medicine:Immunotherapy on Trial for New-Onset Type 1 Diabetes
- ^ MSNBC News: Pioneering Diamyd(r) Study to Prevent Childhood Diabetes Approved
- ^ Diamyd press release: Diamyd approved for groundbreking study in Norway
- ^ Annals of Neurology: Gene therapy for pain: Results of a phase I clinical trial,
- ^ Eurekalert: Neurologix announces positive results of gene therapy clinical trial in Parkinson's disease
- ^ The Lancet Neurology, 17 March 2011: AAV2-GAD gene therapy for advanced Parkinson's disease: a double-blind, sham-surgery controlled, randomised trial
- ^ DIAMYD: DIAMYD GETS AUTHORIZATION TO BEGIN PHASE III STUDY IN THE US
- ^ DIAMYD: DIAMYD DIABETES VACCINE RECEIVES APPROVAL TO START PHASE III TRIALS IN EUROPE
- ^ Clinicaltrials.gov: Effects of Recombinant Human Glutamic Acid Decarboxylase
- ^ Clinicalttrials.gov. Efficacy and Safety of Diamyd in Children and Adolescents With Type 1 Diabetes
- ^ DIAMYD: DIAMYD DIABETES STUDY INVALIDATED
- ^ Moneywatch.com: Diamyd Receives Compensation From Apoteket AB
Categories:- Companies listed on the OMX exchanges
- Pharmaceutical companies of Sweden
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