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  • Ulf Hannelius

    CEO


    Box 7349, SE-103 90 Stockholm
    +46 8 661 00 26
    +46 8 661 63 68
    https://www.diamyd.com

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    The collected genetic and immunological insights support the possibility that we may be able to truly individualize the treatment.
    Ulf Hannelius, CEO
    Our top strategic priority is to prepare for a marketing application for Diamyd®
    Ulf Hannelius, CEO
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    In-depth analysis of Diamyd® Phase II trial further supports value of preserved insulin secretion

    An in-depth analysis of the continuous glucose monitoring data from the phase 2b trial DIAGNODE-2 with Diamyd[®] sheds new light on the importance of residual beta cell function in individuals recently diagnosed with Type 1 Diabetes. Most notably, the results show highly statistically significant and positive associations between residual beta cell function measured as stimulated C-peptide and reduction of the number and severity of hyperglycemic events, in other words episodes of high blood glucose levels, as well as improvments in glucose control during meal time. The results lend further

    A new analysis that supports the effect of the diabetes vaccine Diamyd® will be presented at a scientific conference on 13 October

    A new analysis that shows the effect of the diabetes vaccine Diamyd[®] (GAD-alum) in reducing the time a patient has high blood glucose, has been selected to be presented at the ISPAD conference (The International Society of Pediatric and Adolescent Diabetes), which this year will be held on 13-15 October. The analysis is based on data from Continuous Glucose Montitoring (CGM) and will be presented by Professor Johnny Ludvigsson, Principal Investigator of the clinical trial DIAGNODE-2.The analysis shows that individuals with type 1 diabetes who carry the gene HLA DR3-DQ2, 15 months after

    24-month follow-up of Phase IIb Diamyd® clinical trial indicates continued similar progression after 15 months

    50 out of the 109 individuals in DIAGNODE-2 who were included in an extension study have now been followed for a total of 24 months. The actively treated individuals carrying HLA DR3-DQ2, in total 15 individuals, followed their expected trajectory from 15 to 24 month, showing no indication of diminishing treatment effect compared to their progression up to to 15 months. As also expected,  safety at 24 months looks good with no difference in adverse events between actively treated and placebo treated individuals.As was disclosed in April 2021, no formal statistical analysis has been

    Diamyd® Phase IIb trial results published in Diabetes Care

    Diabetes Care has published the results of DIAGNODE-2, a Phase IIb trial that evaluated intralymphatic administration of Diamyd Medical’s lead drug candidate Diamyd[®] (GAD-alum) in individuals recently diagnosed with type 1 diabetes. Results showed, in line with a published large-scale metaanalysis of clinical data, that while no treatment benefit was seen in the full patient population, three intralymphatic injections of Diamyd[® ]had a significant and positive effect on the preservation of insulin producing capacity in the predefined subgroup of individuals that carry the HLA DR3-DQ2

    The 24-month follow-up of DIAGNODE-2 with the diabetes vaccine Diamyd® will be presented in early July

    All 50 patients who participated in the extension of Diamyd Medical's Phase IIb trial DIAGNODE-2 with the diabetes vaccine Diamyd[®] have now made their 24-month visit, and data will be presented in early July, but without formal statistical evaluation, as the data refers to a selection of the total of 109 patients in the trial. The top-line results from 15 months were presented in September 2020. The work of starting the Phase III trial DIAGNODE-3 is in full speed with identification and contact with clinics in the USA and Europe.The primary end-point for the DIAGNODE-2 trial was read

    DIAGNODE-2 results and meta-analysis with Diamyd[®] to be presented at diabetes conference

    Results from the phase IIb trial DIAGNODE-2 with intralymphatic administration of Diamyd[®] as well as the large-scale meta-analysis comprising data from more than 600 individuals treated with Diamyd[®] showing significant treatment effect in individuals carrying the HLA DR3-DQ2 haplotype, will be presented as oral abstracts by Professor Johnny Ludvigsson and PhD Ulf Hannelius, CEO of Diamyd Medical at the Scandinavian Society of the Science in Diabetes (SSSD) on March 11, 2021.The abstracts will be presented during the conference session “Diabetes classification and precision medicine”.

    Meta-analysis updated with DIAGNODE-2 results provides further support for a precision medicine approach using Diamyd[®]

    The large scale meta-analysis, previously published in August 2020, based on data from Phase III and Phase II trials in Europe and in the United States with the type 1 diabetes vaccine Diamyd[®] (GAD/alum), has been updated with data from the recenly announced (Sep 2020) European Phase IIb trial DIAGNODE-2. This meta-analysis comprises data from 627 individual patients and provides further support for a positive and statistically significant dose-dependent treatment response on the preservation of endogenous insulin production in individuals with type 1 diabetes that carry the HLA DR3-DQ2

    Diamyd Medical invites to a webcast presentation on September 17 on the results from DIAGNODE-2

    Diamyd Medical announced earlier this week that the diabetes vaccine Diamyd[®] has demonstrated significant effect in a subgroup which covers about half of all type 1 diabetes patients. In connection to this, CEO Ulf Hannelius together with the trial’s  Coordinating Investigator Professor Johnny Ludvigsson and Professor Mark Atkinson will hold a webcast presentation on Thursday 17 September at 15.00 CET. The presentation is hosted by News Agency Direkt and Direkt Studios and can be watched at https://youtu.be/UH6sr8WIbaQ   About Diamyd Medical Diamyd Medical develops

    Phase IIb topline results demonstrate a significant treatment effect of Diamyd[®] in a previously identified genetic subgroup of individuals with type 1 diabetes

    Diamyd Medical today announced the topline results from the placebo-controlled Phase IIb trial DIAGNODE-2, where the diabetes vaccine Diamyd[®] (GAD-alum) was injected directly into a lymph node in individuals with recently diagnosed type 1 diabetes. In line with previous large-scale analysis of trials involving subcutaneous administration of Diamyd[®], the reults, encompassing a total of 109 patients, showed a statistically significant effect in the predefined HLA (Human Leukocyte Antigen) subgroup of trial participants. Specifically, this trial demonstated a preservation of beta cell

    All patients have completed their 15-month visits in the European Phase IIb trial with the diabetes vaccine Diamyd[®]

    Diamyd Medical's Phase IIb trial DIAGNODE-2 with the diabetes vaccine Diamyd[®] (GAD65-alum) is expected to present Topline results at the end of September. All patients in the trial where Diamyd[®] is given directly into the lymph node have completed their 15-month visits according to plan.“We have seen a great deal of interest and commitment to the trial from our trial participants, clinics and collaboration partners”, says Johnny Ludvigsson, Professor at Linköping University and Coordinating Investigator for the trial. “There is a great need for new treatments for type 1 diabetes. The

    Patients will be offered longer participation in the European Phase IIb trial with the diabetes vaccine Diamyd®

    Following approval from the Competent Authorities and Ethics Committees in Spain, the Czech Republic, Sweden and the Netherlands, Diamyd Medical can now offer the patients participating in the diabetes trial DIAGNODE-2 who have not yet performed their last visit at 15 months, to be included in a 9 month extension of the trial, which means that these patients will be followed for a total of 24 months. Top-line results of the trial will, as previously announced, be presented after 15 months, in the third quarter of 2020. The purpose of the longer follow-up is to further strengthen the

    Fully recruited European Phase IIb trial with the diabetes vaccine Diamyd®

    All patients in Diamyd Medical's European Phase IIb trial DIAGNODE-2, where the diabetes vaccine Diamyd® (rhGAD65/alum) is given directly into the lymph node, are now randomized and the trial is thus fully recruited. In total, 109 of originally 106 planned patients are included. The patients will be followed for 15 months and topline results are expected in the third quarter next year.In the Phase IIb trial DIAGNODE-2, a total of three injections of the Diamyd® diabetes vaccine (or its placebo) are given to patients aged 12-24 years, recently diganosed with type 1 diabetes, in order to

    Diamyd Medical announces strategic activities for 2019 and 2020

    With experience from clinical trials in more than 1,000 patients with the diabetes vaccine Diamyd®, preparations for a Conditional Marketing Authorization Application in Europe end of 2020 are underway. This includes regulatory, manufacturing and commercial activities as well as preparations for a Phase III clinical trial in Europe and the US, to be completed post-approval in support of an accelerated approval process.“As seen in the DIAGNODE-1 trial, where 11 out of 12 patients remain in Partial Remission at 15 months, it seems that our intra-lymphatic injections of Diamyd® finally may

    European Phase IIb trial in type 1 diabetes with the diabetes vaccine Diamyd® close to being fully recruited

    91 out of a total of 106 patients with type 1 diabetes are included in the European phase IIb trial DIAGNODE-2, where the diabetes vaccine Diamyd® is given directly into the lymph node with the aim to preserve the patients’ endogenous insulin production. As previously announced, results from the trial are expected during the third quarter of 2020.The Phase IIb trial DIAGNODE-2 is a follow up trial based on a smaller investigator initiated pilot trial, DIAGNODE-1, where results show that 11 out of 12 patients recently diagnosed with type 1 diabetes are in a so called honeymoon period, also

    75 percent of patients now enrolled in Diamyd Medical’s European Phase II trial

    Three quarters, 80 out of 106 patients, are included in the European Phase II trial  DIAGNODE-2, where the diabetes vaccine Diamyd® is administered directly into the lymph node. In January, a new clinic is expected to open for recruitment in Rotterdam, the Netherlands.“The interest in DIAGNODE-2 continues to be high,” says Ulf Hannelius, CEO of Diamyd Medical. “The goal is a fully recruited trial in the first quarter of 2019. I would like to wish everyone Happy Holidays and best wishes for the New Year.” About type 1 diabetesType 1 diabetes is an autoimmune disease where the beta cells,

    Strategic expansion of Diamyd Medical's European Phase II trial in Type 1 diabetes

    This is a resubmission of the earlier press release on August 21, 2018, in which it was incorrectly referred to the Market Abuse Regulation. The Swedish Medical Products Agency has approved an expansion of DIAGNODE-2, the Phase II trial where the diabetes vaccine Diamyd® is administered directly into the lymph node, to comprise a total of approximately 106 patients. The expansion, which is awaiting approval in Spain and the Czech Republic, is being made to increase the trial’s statistical power and weight in the development of the antigen-specific intralymphatic immunotherapy Diamyd® for

    Strategic expansion of Diamyd Medical's European Phase II trial in Type 1 diabetes

    The Swedish Medical Products Agency has approved an expansion of DIAGNODE-2, the Phase II trial where the diabetes vaccine Diamyd® is administered directly into the lymph node, to comprise a total of approximately 106 patients. The expansion, which is awaiting approval in Spain and the Czech Republic, is being made to increase the trial’s statistical power and weight in the development of the antigen-specific intralymphatic immunotherapy Diamyd® for Type 1 diabetes.The application for amendment to allow recruitment of approximately 26 more patients to a total of 106 participants, has been

    Update regarding the manufacturing of Diamyd® drug substance

    Diamyd Medical and the Company’s manufacturer of recombinant GAD, the active component of the diabetes vaccine Diamyd®, are working on an updated plan for the new batches of GAD that Diamyd Medical ordered last year for use in late clinical trials and possible early market launch. Manufacturing of the new batches will according to the updated plan be finalized within a time frame that coincides with results from the DIAGNODE-2 trial, which also optimizes the shelf life of the drug substance. About DIAGNODE-2The placebo-controlled trial DIAGNODE-2 encompasses approximately 80 patients

    50% enrollment milestone reached in Diamyd Medical’s European Phase II trial

    Half of the patients, 40 out of 80, are now included in the European Phase II trial DIAGNODE-2, where the diabetes vaccine Diamyd® is administered directly into the lymph node.“We are very pleased with the great interest in DIAGNODE-2, and the great commitment from the 18 leading clinics in Spain, the Czech Republic and Sweden where the trial is conducted, which enables the efficient recruitment of trial participants,” says Ulf Hannelius, CEO of Diamyd Medical.   As of April 23, 54 patients have been screened to assess if they are eligible to participate in the trial. Of these, 40 have

    High interest from patients to participate in the DIAGNODE-2 trial

    Five patients are now enrolled in the European phase II trial DIAGNODE-2 and several patients are scheduled for screening during the forthcoming weeks. Out of these first five patients, one patient has had the first intralymphatic injection of the diabetes vaccine Diamyd® (or its placebo) after a 30-day period of oral treatment with vitamin D (or its placebo).“I am very pleased to notice a great interest from patients and parents of younger patients to participate in the trial,” says Professor Johnny Ludvigsson, University of Linköping, Coordinating Investigator of DIAGNODE-2. “It is our

    The website www.diagnode-2.com launched for recruitment of patients for DIAGNODE-2 trial

    www.diagnode-2.com is aiming to reach patients aged 12–24 years recently diagnosed with type 1 diabetes and their relatives, to inform about the opportunity to volunteer to participate in the DIAGNODE-2 clinical trial.The website for the European Phase II trial DIAGNODE-2 has been approved by the Ethics Committees in the participating countries Sweden, the Czech Republic and Spain. Information regarding the clinics’ recruitment status will be updated continuously when sites become activated to recruit patients. For further information about DIAGNODE-2 and participating clinics, please visit

    Phase II-trial DIAGNODE-2 ahead of World Diabetes Day now open to include patients

    Diamyd Medical's pivotal trial DIAGNODE-2 is now open for booking patients. The diabetes vaccine Diamyd® for intralymphatic administration will be delivered to the clinics participating in the trial that can begin screening patients. DIAGNODE-2 comprises about 80 patients from Spain, the Czech Republic and Sweden between the ages of 12-24 who have been diagnosed with type 1 diabetes in the last 6 months.“Given the highly promising data we have seen from DIAGNODE-1, it is of course a great event and a potential opportunity for diabetes patients, and we are particularly pleased that we can

    Financial Statement 16/17

    September 2016 – August 2017, Diamyd Medical AB (publ), Fiscal year 2016/2017The period September 1, 2016 – August 31, 2017 in brief · R&D-expenses amounted to MSEK -12.9 (-6.2) of which the fourth quarter constituted MSEK -3.1 (-1.9) · Net result amounted to MSEK -25.6 (-32.0) of which the fourth quarter amounted to MSEK -6.5 (-4.8). Previous year’s result was charged with an impairment in associated company of MSEK -13.5 · Result per share, before and after dilution, amounted to SEK -0.7   (-1.3) of which the fourth quarter constituted SEK -0.1 (-0.2) · Cash flow from

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