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Diamyd Medical

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Diamyd Medical AB (Nasdaq Stockholm: 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 FDA. The company will perform a parallel phase III trial in Europe.

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. Phase III trials are under way in the USA and in Europe. [2] [3] Future applications can include latent autoimmune diabetes[4] and prevention of type 1 diabetes.

- 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 been approved.[1]

Licences

- NeuroLogix has a licensed the use of a gene GAD65 from Diamyd Medical for Parkinson's disease.[5]

Investments

- Diamyd owns substantial shares of Mercodia, a company manufacturing diagnostic products for e.g. diabetes.
- Protein Sciences Corporation, the vaccine company which produces the Diamyd GAD65 vaccine.

Ongoing Trials

Phase III trial in USA [6]
Phase III trial in Europe [7]
Phase II trial sponsored by NIDDK [8]

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[2] [9]
Phase II LADA trial in Europe (aborted) [10]

Referenses

  1. ^ a b Presentation from the Extra General Shareholders Meeting on March 10, 2008: In the treatment of Diabetes and Diabetes related complications
  2. ^ a b Further Evidence for Lasting Immunological Efficacy of Diamyd Diabetes Vaccine
  3. ^ Diamyd Announces Completion of Type 1 Diabetes Vaccine Trial with Long Term Efficcacy Demonstrated at 30 Months
  4. ^ Beta cell function and metabolic control during two years of follow-up after GAD65 dose-escalation immunomodulation in adult-onset autoimmune diabetes
  5. ^ Eurekalert: Neurologix announces positive results of gene therapy clinical trial in Parkinson's disease
  6. ^ DIAMYD: DIAMYD GETS AUTHORIZATION TO BEGIN PHASE III STUDY IN THE US
  7. ^ DIAMYD: DIAMYD DIABETES VACCINE RECEIVES APPROVAL TO START PHASE III TRIALS IN EUROPE
  8. ^ Clinicaltrials.gov: Effects of Recombinant Human Glutamic Acid Decarboxylase
  9. ^ Clinicalttrials.gov. Efficacy and Safety of Diamyd in Children and Adolescents With Type 1 Diabetes
  10. ^ DIAMYD: DIAMYD DIABETES STUDY INVALIDATED
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