Immunological results from a study with Diamyd® will be presented in April
Diamyd Medical (Nasdaq Stockholm First North Ticker: DMYD B) informs that immunological results from DIABGAD, one of five ongoing studies with the diabetes vaccine Diamyd®, will be presented at an international diabetes congress (IDS) held in Munich on April 12 to 16, 2015.
Immunological findings from a study with Diamyd®, DIABGAD, will be presented by Professor Johnny Ludvigsson at an international diabetes meeting held in Munich on April 12-16, 2015. Preparations for the code break are ongoing and the code will be broken and the results analyzed shortly before the presentation. In the study, which is one of five ongoing studies with Diamyd®, Diamyd® plus vitamin D and ibuprofen is tested in order to strengthen the 16 percent (p = 0.10) average effect Diamyd®, as monotherapy, demonstrated compared to placebo in a European Phase III study.
Among the speakers at the congress are several members of Diamyd Medical's Scientific Advisory Board; Professors Mark Atkinson, Åke Lernmark, Bart Roep and David Leslie. In addition, Anders Essen-Möller from Diamyd Medical is invited to give his views on the development of a diabetes vaccine from an industrial perspective.
To be noted is that Craig Beam, Professor of Biostatistics, Kalamazoo, US, is invited to discuss the Bayesian statistical methods with which he recently reanalyzed results from three studies with the diabetes vaccine Diamyd® comprising more than 500 type 1 diabetes patients. The conclusion of the analysis of the European Phase III study is that the diabetes vaccine Diamyd® is effective with a probability of 97%. Prominent diabetes researchers who are co-authors to Craig Beam’s analysis results for Diamyd® include Jerry Palmer, Diane Wherrett, Kevin Herold, Johnny Ludvigsson, Colleen MacCallum and researchers within the Type 1 Diabetes TrialNet Study Group.
The immunological results to be presented are from 6 months after the patients were enrolled in the study. The total number of patients is 64, divided into four groups: a) Diamyd® in combination with ibuprofen and vitamin D, b) Diamyd® in combination with vitamin D, c) Diamyd® in double dose in combination with vitamin D; d) Placebo (inactive substance).
“We hope that the six-month results will show that this autoimmune disease is now modulated in the right direction,” says Anders Essen-Möller, President and CEO of Diamyd Medical. “If so, we have good hope that this, at 15 months, will provide a long-term positive effect on metabolic parameters such as the own ability to produce insulin. The last patient will perform the 15 month visit in September 2015 and metabolic results from the study are planned to be presented by the end of this year.”
About the diabetes vaccine Diamyd®
Type 1 diabetes is a devastating disease which requires daily treatment with insulin to sustain life. The importance of finding a cure cannot be underestimated. Diamyd® is considered to be the world’s furthest developed Antigen Based Therapy (ABT) for treating the disease. Diamyd® has been used in clinical studies with more than 1,000 patients and has shown a good safety profile. In a European Phase III study Diamyd® showed good clinical effect in several subgroups, and a limited overall 16% efficacy (p=0.10) in preserving endogenous insulin secretion. To enhance the overall effect, combination treatments with Diamyd® and other approved agents are being pursued. Diamyd® is easy to administer in any clinical setting. The potential annual market is estimated to several billion dollars.
About Diamyd Medical
Diamyd Medical is dedicated to working toward a cure for type 1 diabetes. The Company’s projects include development of combination regimens with the GAD-based diabetes vaccine Diamyd® for arresting the destruction of insulin-producing beta cells. The Company exclusively licenses UCLA-rights to GAD65, the active ingredient in the vaccine, for which the last patent expires in 2032. Additionally, the Company exclusively licenses UCLA patents for using GABA for the treatment of diabetes and other inflammation-related conditions.
Diamyd Medical is one of the major shareholders in the stem cell company Cellaviva AB, which is establishing a Swedish commercial bank for private family saving of stem cells in umbilical cord blood and other sources of stem cells. Stem cells can be expected to be used in Personalized Regenerative Medicine (PRM), for example, to restore beta cell mass in diabetes patients where autoimmunity has been arrested.
Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, President and CEO
Phone: +46 70 55 10 679. E-mail: anders.essen-moller@diamyd.com
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: info@diamyd.com. Reg. no.: 556242-3797. Website: www.diamyd.com.
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