Interim report from DIAGNODE-1 supports continued positive clinical course after 15 months
Diamyd Medical today announces that a fourth interim report from the researcher-initiated trial DIAGNODE-1 shows a positive clinical progression in terms of the body’s own capacity to produce insulin, as well as long-term blood sugar and insulin dose when half of the patients have been followed for 15 months.
In a fourth interim report from the open label researcher-initiated clinical pilot trial DIAGNODE-1, where the diabetes vaccine Diamyd® is administered directly into the lymph node, results are presented for six out of a total of twelve patients that have been followed for 15 months. Safety continues to look good and no serious side effects have been reported. On average, the group’s own ability to produce insulin (measured by C-peptide, AUC) decreased by 10.8 % while fasting C-peptide increased by 23%. Meanwhile, HbA1c and insulin dose were reduced by 31 and 39 %, respectively. In summary, these data indicate that the disease progression continues to be positive at 15 months for these six patients and is in line with previously reported results from the trial.
DIAGNODE-1 is an open label pilot trial, comprising a total of twelve patients between the ages of 12 and 30 with type 1 diabetes, where a low dose of the diabetes vaccine Diamyd® is administered directly into the lymph node in combination with treatment with vitamin D. Six patients (two new patients) have been followed for 15 months, and nine patients have been followed for 6 months from inclusion in the trial, that is, 12 and 3 months after the third injection with diabetes vaccine Diamyd® (4μg per dose) directly into the lymph node.
About Diamyd Medical
Diamyd Medical is dedicated to finding a cure for diabetes and other serious inflammatory diseases through pharmaceutical development and investments in stem cell and medical technology.
Diamyd Medical develops the diabetes vaccine Diamyd®, for antigen-specific immunotherapy based on the exclusively licensed GAD-molecule. Four clinical trials are ongoing with Diamyd®. The Company's trial DIAGNODE-2, where the diabetes vaccine is administered directly into the lymph node, is expected to start recruiting patients in the fall. An exclusive license for GABA for the treatment of diabetes and inflammatory diseases constitutes alongside with the diabetes vaccine a key asset in Diamyd Medical and the Company uses its GABA in-licensed technology to develop a GABA drug product. Diamyd Medical is one of the major shareholders in the stem cell company NextCell Pharma AB. Diamyd Medical also has holdings in the medtech company Companion Medical, Inc., San Diego, USA and in the gene therapy company Periphagen, Inc., Pittsburgh, USA.
Diamyd Medical’s B-share is traded on Nasdaq First North under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
For further information, please contact:
Ulf Hannelius, President and CEO
Phone: +46 736 35 42 41
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: firstname.lastname@example.org. Reg. no.: 556242-3797. Website: www.diamyd.com.
This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:17 CET on July 6, 2017