New interim report for Diamyd® directly into the lymph node indicates continued positive clinical course
Diamyd Medical today announced that a third interim report from DIAGNODE-1, an open clinical pilot trial where the diabetes vaccine Diamyd® is administered directly into the lymph node, when nine patients have been followed for 6 months, preliminarily shows that the treatment appears to be safe and tolerable. The clinical progression in the patients is positive in terms of the body’s own capacity to produce insulin, as well as long-term blood sugar and insulin dose. Two of the three patients that now have been followed for 6 months are children (12–18 years of age).
"It is gratifying that results from three more patients at six months support the positive effect we have seen with intralymphatic treatment," says Johnny Ludvigsson, Professor at Linköping University, Principal investigator and Sponsor of the trial. “Now we also have results in two younger patients, which is important for evaluating the safety and efficacy of the treatment.”
Earlier this year, preliminary 6-month data were published for six patients and 15-month data for four patients in the New England Journal of Medicine by Professor Johnny Ludvigsson. Now 6-month data are reported for three more patients, which gives results from a total of nine patients at 6 months. Two of the three new patients are children, which in this trial means that they are between 12 and 18 years of age. 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) increased by 0.4 %, while fasting C-peptide decreased by 4 %. Meanwhile, HbA1c and insulin dose were reduced by 31 and 26 % respectively. In summary, these data indicate that the disease progression continues to be positive at 6 months for these nine patients and is in line with previously reported results from six patients.
"These new data provide additional support for the clinical effect of intralymphatic administration of the diabetes vaccine Diamyd®, facilitating our business development activities and the planning of the follow-up placebo-controlled DIAGNODE-2,” says Ulf Hannelius, CEO of Diamyd Medical.
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. Four patients have been followed for 15 months, and nine patients (three new 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. Five clinical studies are ongoing with Diamyd®. The Company's trial DIAGNODE-2, where the diabetes vaccine is administered directly into the lymphatic node, is expected to start recruiting patients in the fall. GABA constitutes alongside with the diabetes vaccine a key asset in Diamyd Medical and the Company uses its GABA in-licensed technology to develop a proprietary 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
E-mail: ulf.hannelius@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.
This information is information that Diamyd Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. This is an English translation of information that was submitted for publication, through the agency of the contact person set out above, at 08:17 CET on June 9, 2017.
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