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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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    Preliminary results from GABA/Diamyd® trial

    Preliminary results from the US investigator initiated GABA/Diamyd® trial were presented today at the annual meeting of the EASD in Barcelona, Spain. Initial analyses indicate that GABA alone or in combination with two 20 µg Diamyd® injections under the skin (in contrast to three injections into a lymphnode as in the ongoing DIAGNODE trials) to recent onset type 1 diabetes patients does not significantly affect insulin production, blood glucose values or insulin dose compared to placebo. A potential positive effect of GABA on lowering glucagon levels was observed. No serious side effects were

    A new publication supports Diamyd Medical’s patent rights around GABA

    A new scientific article published in Journal of Diabetes Research supports previous findings that form the basis of patent applications that Diamyd Medical exclusively licenses from University of California, Los Angeles (UCLA). The study shows that treatment with GABA in combination with the GABA receptor modulating agent Alprazolam provides increased effect on the survival and growth of insulin-producing cells in animals.The authors behind the publication, active at UCLA, have investigated the influence of GABA and the GABA receptor modulator Alprazolam on diabetic mice transplanted with

    The GABA/Diamyd® trial in the US now fully recruited

    The placebo-controlled trial evaluating GABA in combination with Diamyd®, conducted at the University of Alabama at Birmingham in the U.S, is now fully recruited and has included 101 patients. Of these, 56 patients have already completed the entire trial. No serious side effects have been reported."The trial in Alabama is important in our commitment to GABA-based drugs in diabetes," says Ulf Hannelius, CEO of Diamyd Medical. “It gives us vital insights both regarding GABA:s therapeutic effects alone in type 1 diabetes as well as in combination with Diamyd®. Along with Remygen® and ongoing

    Diamyd Medical’s Remygen™ for regeneration of insulin-producing cells approved for clinical trials

    The Swedish Medical Products Agency has approved the initiation of the clinical Phase I/II trial ReGenerate-1, with Diamyd Medical's patent-pending study drug Remygen™. In addition to evaluating the safety of the study drug, the trial will investigate Remygen's ability to regenerate insulin-producing beta cells in patients with diabetes who have little or no endogenous insulin production."The positive decision by the MPA is very pleasing and a significant milestone for us as a company as we now have two study drugs, Diamyd® and Remygen™, in clinical phase," says Ulf Hannelius, CEO of Diamyd

    Results showing GABA’s relevance for diabetes, patent filed by Diamyd Medical and Uppsala University scientist, published in eBioMedicine

    Diamyd Medical holds, in collaboration with Professor Bryndis Birnir at Uppsala University, patent pending new GABA results. The results, now published in the scientific journal eBioMedicine, supports GABA’s role as a therapeutic important signal substance in the insulin producing beta cells and in immune cells from healthy humans as well as from patients with type 1 and type 2 diabetes.The results, published in two separate articles, identify new biomarkers and support the therapeutic effect of GABA treatment in humans. In the first article, an international research team lead by Professor

    The GABA/Diamyd®   trial in the US fully recruited this summer

    In the placebo-controlled combination trial GABA/Diamyd® conducted at University of Alabama at Birmingham, US, 82 patients have now been included, of which 48 have completed the entire trial. No serious side effects have been reported and the treatment appears to be safe. The trial is expected to be fully recruited this summer.GABA/Diamyd® is a three-arm, double-blind and placebo-controlled trial including a total of 95 children and adolescents between 4 and 18 years, recently diagnosed with type 1 diabetes. The patients are randomly assigned to one of three treatment groups: a) two

    Diamyd Medical strengthens GABA portfolio with new license

    Diamyd Medical has concluded a new exclusive licensing agreement with University of California, Los Angeles (UCLA) Technology Development Group on behalf of UC Regents. The license relates to new patent applications for the therapeutic use of GABA (gamma-aminobutyric acid) with positive allosteric modulators of the GABAA receptor to enhance beta cell regeneration, survival and immunomodulation.“This new GABA license together with our existing license, patent applications, and our proprietary GABA study drug Remygen®, provide a strong development platform to fully realize the therapeutic and

    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

    Update on the strategic development of the study drug Remygen®

    Diamyd Medical has filed a preliminary patent application on the formulation and release characteristics of the GABA-based study drug Remygen®. Based on the feedback from a scientific meeting yesterday with the Swedish Medical Products Agency, and in collaboration with Diamyd Medical’s scientific network, the Company will now commence designing the first clinical trial based on Remygen® and defining the long-term drug development strategy.“The development of Remygen® marks a significant milestone for Diamyd Medical,“ says Ulf Hannelius, CEO of Diamyd Medical. “We can now see the results of

    Diamyd Medical receives increased patent protection

    Diamyd Medical today announced that the U.S. Patent Attorney at the University of California, Los Angeles, (UCLA), has informed that another Diamyd Medical licensed UCLA patent application will be granted. The patent includes protection for treating type 1 diabetes with the combination GABA and the diabetes vaccine Diamyd® and has a maturity until September 27, 2031. Previously, a patent within the same patent family has been granted covering diabetes treatment with GABA and preproinsulin or an immunogenic fragment thereof.Diamyd Medical has previously licensed several approved independent

    PGVinvest AB invests in Diamyd Medical

    Diamyd Medical today announced that the investment company PGVinvest AB has acquired 953,333 series B unit rights and 46,667 series B shares in Diamyd Medical from Anders Essen-Möller, major owner of Diamyd Medical. All unit rights and shares were taken from an endowment insurance, meaning that the holding specified for Essen-Möller in the published prospectus remains unchanged. Anders Essen-Möller has announced that the entire sales proceeds will be used as part of Essen-Möller’s forthcoming investment in Diamyd Medical’s impending rights issue. About Diamyd MedicalDiamyd Medical

    Diamyd Medical prepares GMP-production of GABA

    Diamyd Medical announced today that a first amount of GABA has been produced and that the manufacturing process is to be scaled up for GMP production. The Company also highlights that two recently published scientific articles support GABA's relevance in the treatment of diabetes.Diamyd Medical has, as previously reported, expanded its operations to include type 2 diabetes and rheumatoid arthritis, where a significant part of the development plan is manufacturing of a proprietary GABA drug product. Diamyd Medical has during the autumn visited its selected manufacturer. GABA synthesis and

    Diamyd Medical starts producing proprietary GABA drug and expands its Scientific Advisory Board

    Diamyd Medical (Nasdaq Stockholm First North, DMYD B) today announced that production of a proprietary GABA drug has started. Concurrently, the Scientific and Medical Advisory Board is expanded with two leading experts in rheumatoid arthritis and type 2 diabetes, Professor Daniel Furst, University of California, Los Angeles (UCLA) and Associate Professor Michael Alvarsson, Clinic Director at the Karolinska University Hospital.Diamyd Medical has as previously reported broadened its operations to include type 2 diabetes and rheumatoid arthritis with its own GABA drug. Development of a GABA-

    Diamyd Medical expands activities to both type 1 and type 2 diabetes as well as rheumatoid arthritis with proprietary GABA drug

    Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that the Company will expand its activities to include both type 1 and type 2 diabetes as well as rheumatoid arthritis, which is planned to be pursued through the development of a proprietary GABA drug product.GABA forms alongside the diabetes vaccine Diamyd® a key asset of Diamyd Medical. To further develop GABA’s potential, Diamyd Medical expands, in dialog with leading experts in the field, its activities towards both type 1 and type 2 diabetes as well as rheumatoid arthritis. Results from previously published

    Diamyd Medical provides update on clinical studies with Diamyd®

    Diamyd Medical (Nasdaq First North, Stockholm, DMYD B) participates in six clinical studies with the diabetes vaccine Diamyd® for the treatment and prevention of type 1 diabetes. The Company announced today that yet another of these, the phase II study EDCR IIa now is fully enrolled and that results from a first evaluation after 6 months are estimated to be presented during the second quarter of 2017. The Company also announced that results from the placebo-controlled prevention study DiAPREV-IT 1 are expected to be presented during the first quarter of 2017.All 20 patients are now included

    Diamyd Medical signs agreement with Janssen R&D, JDRF and UAB regarding ongoing GABA/GAD-trial

    Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that it has signed an agreement with Janssen Research & Development, the Juvenile Diabetes Research Foundation (JDRF) and the University of Alabama at Birmingham regarding the ongoing clinical trial “Effect of GABA or Combination GABA/GAD on the Progression of Type 1 Diabetes Mellitus in Children”. The agreement entails that Janssen Research & Development and JDRF will support the trial with approximately USD 600 000 to be used to study GABA-biomarkers and to increase the number of patients in the trial.“The

    Diamyd Medical and UCLA advance therapeutic development for type 1 diabetes

    Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) announced today that Diamyd Medical has agreed to further advance its Antigen Based Technology together with researchers at the University of California, Los Angeles (UCLA). Strong synergistic effects have earlier been reported in an animal model receiving GABA in combination with either GAD65 or proinsulin. This new preclinical study will evaluate if GABA in combination with both autoantigens improves efficacy even further. Diamyd Medical licenses exclusive rights from UCLA for the therapeutic use of GABA alone or in combination

    Diamyd Medical is engaged in discussions regarding an extension of GABA/Diamyd® trial in Birmingham, Alabama

    Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced in its second quarterly report for the fiscal year 2015/2016 that the Company is engaged in discussions regarding an extension of the ongoing GABA/Diamyd®-trial in Birmingham, Alabama. The Company also announced that the associated company Companion Medical, Inc. has submitted a 510(k) Premarket Notification in the US as well as a CE-mark application in Europe.Moreover, the CEO’s comments in today’s quarterly report reads as follows. The second quarter of this fiscal year and the period thereafter have been

    Diamyd Medical agrees on new GABA/GAD study

    Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced that the Company has signed an agreement with Uppsala University and Uppsala University Hospital to conduct a clinical study with the diabetes vaccine Diamyd® combined with one or several GABA-related substances for which the stem cell researcher Professor Per-Ola Carlsson will be the Principal Investigator.The planned researcher-initiated combination study will be discussed with the Swedish Medical Products Agency this spring and is the first of its kind where GABA combined with the diabetes vaccine Diamyd® will

    Diamyd Medical’s major owners fully subscribe for their share of a rights issue

    Not for release, publication or distribution, directly or indirectly, in the United States, Canada, Australia, Hong Kong, Japan, New Zealand, Singapore, Switzerland, Singapore or South Africa. Diamyd Medical (NASDAQ Stockholm First North, DMYD B), world leader in the development of Antigen Based Therapy for type 1 diabetes, announced today that its major owners, Bertil Lindkvist and Anders Essen-Möller, notified that they will take up their share corresponding to approximately one third of the upcoming rights issue of SEK 22.1 million.Diamyd Medical’s rights issue is implemented with the

    Diamyd Medical implements aggressive rights issue

    Not for release, publication or distribution, directly or indirectly, in the United States, Canada, Australia, Hong Kong, Japan, New Zealand, Singapore, Switzerland, Singapore or South Africa. Diamyd Medical (NASDAQ Stockholm First North, DMYD B), world leader in the development of Antigen Based Therapy for type 1 diabetes, announced today that its Board of Directors, with authorization from the Annual General Meeting held on November 26, 2015, decided to offer shareholders to subscribe for new shares at a substantial discount compared to yesterday’s market price. The offer means that

    Diamyd Medical plans first interim report from the study DIAGNODE-1 where the diabetes vaccine Diamyd® is administered directly into lymph nodes

    Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) today announced in its first quarterly report for the fiscal year 2015/2016 that a first six month interim report for DIAGNODE-1, a clinical pilot study where the diabetes vaccine Diamyd® is administered directly into the lymph node, is intended to be presented during the first quarter of 2016. The study is open labeled, meaning not placebo-controlled. Professor Johnny Ludvigsson, Linköping University, is principal investigator and sponsor of the study. The report also announced that pre-clinical testing is ongoing to produce

    Quarterly Report I 15/16

    September 2015 – November 2015Diamyd Medical AB (publ), Fiscal year 2015/2016Reporting period, September 1, 2015 – November 30, 2015 · Net result amounted to MSEK -4.3 (-5.9) · Net result per share amounted to SEK -0.2 (-0.3) · Cash flow from operating activities amounted to MSEK -4.8 (-5.8) · Liquid assets and short term investments amounted at the end of the period to MSEK 24.9 (29.8) Significant events after the reporting period · Preliminary 15-month results from DIABGAD, a 30-month pilot study with the diabetes vaccine Diamyd® in combination with vitamin D and

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