First intralymphatic trial with Diamyd® fully recruited
The open trial DIAGNODE-1 is now fully recruited after 12 patients. Diamyd Medical, together with Professor Johnny Ludvigsson at Linköping University, Principal investigator and Sponsor, has decided to close the recruitment of patients in the DIAGNODE-1 trial to begin the follow-up of patients already now and focus on the larger follow-up trial DIAGNODE-2.
According to the protocol, the trial may include about 15 patients and a decision has been taken to close the recruitment at these 12 patients to initiate follow-up of the patients and to prepare for the larger phase II trial DIAGNODE-2. 6-month results from all 12 patients will be presented in the fourth quarter of 2017, when all patients have completed their 6-month visit, data have been monitored, collected and analyzed. 6- and 15-month results on a limited number of patients may also be expected to be presented at some prior occasions preceding discussions with potential partners, presentations at scientific meetings or for other purposes where results have an important strategic or operational purpose.
"We place great emphasis on intralymphatic administration of Diamyd® in newly diagnosed type 1 diabetes patients," says Ulf Hannelius, CEO of Diamyd Medical. “By completing the recruitment after 12 patients in DIAGNODE-1, we and our collaborators can clearly prioritize resources for the most value-driving activities - to start the follow-up DIAGNODE-2 trial and analyze the clinical and immunological processes in DIAGNODE-1.”
As previously announced, Diamyd Medical has decided to finance and conduct a pivotal follow-up clinical trial in children and adolescents recently diagnosed with type 1 diabetes. The placebo-controlled Phase II trial, DIAGNODE-2, investigates, as in DIAGNODE-1, an innovative and patent pending concept where the diabetes vaccine Diamyd® is administered directly into the lymph node. The trial will be conducted in Sweden, Spain and the Czech Republic at selected diabetes clinics, with established contacts and interests to achieve the best possible cooperation and patient recruitment. The application for conduct of the trial has been submitted to the Swedish Medical Products Agency and the Ethics Committee in Sweden, and now follows the applications to have the trial approved by the respective Competent Authorities in Spain and the Czech Republic, as well as to the relevant Ethics Committee in these countries. DIAGNODE-2 is expected to start recruiting patients this autumn 2017.
Update on ongoing clinical researcher initiated studies with Diamyd®
In the placebo-controlled trial GABA/GAD, where Diamyd® is investigated in combination with GABA, 68 patients have now been included and 31 of them have already completed the entire trial. No serious related adverse events have been reported and the trial seems safe. The trial comprises 95 patients between the ages of 4 and 18, who have recently been diagnosed with type 1 diabetes and each patient is followed for 12 months. The trial is conducted in the US and is led by Dr. Alexandra Martin at the University of Alabama at Birmingham, Principal Investigator and Sponsor of the trial.
As previously announced, final results from the placebo-controlled prevention trial DiAPREV-IT 1 will be presented by Associate Professor, MD Helena Elding Larsson at the American Diabetes Associations (ADA) conference held in San Diego, USA, 9-13 June 2017. Helena Elding Larsson will hold the presentation Monday June 12, at 6:00 pm, local time.
In the other prevention trial DiAPREV-IT 2, recruitment of participants is ongoing and 26 children have been included. The placebo controlled trial comprises 80 children between 4-18 years of age, where Diamyd® is investigated in children with high risk of developing type 1 diabetes, meaning they have been found to have an ongoing autoimmune process but not yet any clinical symptoms of type 1 diabetes. Each child will be followed for 5 years. The trial is conducted by Associate Professor, MD Helena Elding Larsson at Lund University, Principal Investigator and Sponsor of the trial.
The next evaluation point for the EDCR IIa trial, where Diamyd® is combined with etanercept and vitamin D, is when all patients have completed their 15-month visit, which should be around mid-December 2017. The results are expected to be presented in the first quarter of 2018. The trial is led by Professor Johnny Ludvigsson at Linköping University, Principal Investigator and Sponsor of the trial.
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 Stockholm 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. 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 2, 2017.