Additional preliminary interim results from intralymphatic study with Diamyd® published as part of scientific correspondence in NEJM
New immunological data from the DIAGNODE-1 trial, published as part of a correspondence in the medical periodical New England Journal of Medicine, show a predominant Th2 response when the diabetes vaccine Diamyd® is administered directly into the lymph node being stronger than observed when injecting it under the skin.
The correspondence and data are based on the original article published in NEJM on February 16, 2017, by Professor Johnny Ludvigsson, Principal Investigator and sponsor of the open label pilot trial DIAGNODE-1.
The authors of the correspondence letter comment that measures of variability to the figures should have ben added in order to strengthen the validity of the published preliminary interim results from this small open label pilot trial.
In their answer, Professor Johnny Ludvigsson and co-authors provide measures of variability and also data on the immunological response following intralymphatic administration of Diamyd® that support the previously observed clinical results. The value of pilot trials is also discussed.
In addition to these new immunological data from the researcher-initiated trial DIAGNODE-1 published in NEJM, data from six of a total of twelve patients that have been followed for 15 months that support previously reported interim results were recently press released by Diamyd Medical in a fourth interim report on July 6, 2017.
The full correspondence in New England Jounral of Medicine is available here: http://www.nejm.org/doi/full/10.1056/NEJMc1703468
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. The treatment is combined with oral administration of vitamin D. Half of the 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: email@example.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. The information was submitted for publication, through the agency of the contact person set out above, at 08:17 CET on July 27, 2017