Reporting period, September 1, 2014 – November 30, 2014
- Net result amounted to MSEK -5.9 (-4.8)
- Result per share amounted to SEK -0.3 (-0.2)
- Cash flow from operating activities amounted to MSEK -5.8 (-4.3)
- Liquid assets and short term investments amounted
to MSEK 29.8 (61.0) at the end of the period
Significant events during the reporting period
- Diamyd-licensed technology, GABA in combination with Antigen Based Therapy, cures diabetes in pre-clinical model
- Diamyd® administered directly into lymph nodes will be tested in adults with type 1 diabetes
- Diamyd Medical and Protein Sciences deepen commitment to develop new treatment for diabetes
- Pioneering study combining the diabetes vaccine Diamyd® with GABA in children with type 1 diabetes approved by the US FDA
- New study to prevent type 1 diabetes with the Diamyd® diabetes vaccine approved by the Swedish Medical Products Agency
- Diamyd® in combination with vitamin D and etanercept approved for testing in children and adolescents with type 1 diabetes
- Treatment with GABA enhances transplanted human beta cell mass in preclinical model of type 1 diabetes
Significant events after the reporting period
- Diamyd Medical’s patent protection extended by ten years to 2032
CEO comments
Following an intense autumn with many positives, Diamyd Medical was able to start the New Year with yet more good news. On January 6, 2015, the United States Patent and Trademark Office granted a new patent for GAD65 for the treatment of autoimmune diseases, including diabetes. The GAD65 protein is the active substance in the Diamyd® diabetes vaccine and Diamyd Medical has an exclusive license for the new patent from the University of California, Los Angeles (UCLA). The term of the new patent runs into January 2032, which is more than ten years longer than previous US patent protection for the diabetes vaccine. The longer term should provide time for the remaining development of Diamyd® and many years of marketing in the US without competition. Diamyd® is the furthest developed Antigen Based Therapy for type 1 diabetes in the world.
In December, two new batches of GAD65 protein were manufactured by Protein Sciences in the US. Preliminary analyses indicate that the production went well even if much analytical work remains before the material can be released for use. In accordance with the production agreement from September 2014, Diamyd Medical has issued 100,000 Series B shares to Protein Sciences. Protein Sciences will receive a further 300,000 Series B shares upon release of the material. In addition, a cash amount was paid to Protein Sciences for the manufacturing, which explains the higher costs for the period compared with earlier periods.
The end product Diamyd® is comprised of GAD65 protein from Protein Sciences formulated with the vaccine adjuvant alum. Thus far, the formulation has been done in batches of 3,000 vials by Octoplus in the Netherlands, however, they have recently informed their clients that they plan to phase out their contract manufacturing services. We have a large stock of ready-for-use diabetes vaccine that will suffice until autumn 2017 for all studies, so we have plenty of time to select a new contract manufacturer for the final formulation.
The initial results of the DIABGAD-1 combination study are expected to be presented in the spring. The study encompasses a total of 64 patients between the ages of ten and 18 who have been recently diagnosed with type 1 diabetes. The study will continue for a total of 30 months, but an initial evaluation will take place now after six months with focus on immunological markers. The immunological markers can provide an indication of how the treatment has affected the immune system. However, in this patient group, six months is too short a time for relevant differences to arise between the treatment groups in terms of the clinically most interesting variables, for example, the patients’ ability to produce insulin. The 15-month results from the study, that may be available by the end of 2015, will show what effect the treatment has had on the ability to produce insulin.
DIABGAD-1 is a researcher-initiated study with the Diamyd® diabetes vaccine, in which a group of participants also receive the anti-inflammatory substance ibuprofen. In addition, several of the groups of participating children receive vitamin D to further steer the immune system in the right direction and, concurrently, strengthen the beta cells. The aim of the combination treatment is to preserve the body’s remaining capacity to produce insulin. The study is taking place at nine clinics in Sweden and is led by Professor Johnny Ludvigsson at Linköping University.
In addition to DIABGAD-1, the researcher-initiated DiAPREV-IT study is ongoing in southern Sweden and its results are expected at the end of next year. The study comprises 50 children that have been found to have an ongoing autoimmune process, but do not yet have any clinical symptoms of diabetes, and aims to evaluate whether treatment with Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. In the autumn, four new researcher-initiated studies with the Diamyd® diabetes vaccine were approved in Sweden and the US. Intense efforts are ongoing with getting these studies started and we expect several of them to start recruiting participants in the first quarter of 2015.
Stockholm, January 21, 2015
Peter Zerhouni
President and CEO Diamyd Medical AB (publ)
Significant events during the reporting period
Diamyd-licensed technology cures diabetes in pre-clinical model
Researchers at UCLA have confirmed earlier findings that combinations of GABA and Antigen Based Therapy (ABT) works synergistically as a treatment in the NOD mouse model of type 1 diabetes. Diamyd Medical is the exclusive licensee for the commercialization of UCLA’s GABA technology for metabolic diseases including diabetes.
New method to give Diamyd® will be tested in adults with type 1 diabetes
A new way to give Diamyd® will be tested in a clinical study with five adults newly diagnosed with type 1 diabetes. The investigator initiated study has been approved by the Swedish MPA. In analogy to the development in allergy therapy, where the administration of allergen into lymph nodes has significantly improved the efficacy, Diamyd® will in this study be administered directly into lymph nodes in combination with treatment with vitamin D.
Diamyd Medical and Protein Sciences deepen commitment to develop new treatment for diabetes
Protein Sciences has broadened its commitment to diabetes and become a strategic and significant shareholder in Diamyd Medical, its long-time partner in this domain. Protein Sciences will manufacture product for upcoming late stage clinical trials for type 1 diabetes involving Diamyd Medical’s recombinant GAD (glutamic acid decarboxylase) protein made using Protein Sciences’ proprietary Baculovirus Expression Vector System (BEVS) technology.
Pioneering study combining the diabetes vaccine Diamyd® with GABA in children with type 1 diabetes approved by the US FDA
An investigator initiated study combining the diabetes vaccine Diamyd® and GABA in children with new onset type 1 diabetes has been approved by the US Food and Drug Administration. Diamyd Medical and University of Alabama at Birmingham has entered a Clinical Trial Agreement regarding the study, which will be conducted at Children’s of Alabama in Birmingham, USA. The combination has shown promising results in preclinical studies
New study to prevent type 1 diabetes with the Diamyd® diabetes vaccine approved by the Swedish Medical Products Agency
The Swedish Medical Products Agency has approved the planned new investigator initiated study with the Diamyd® diabetes vaccine in 80 children at high risk of presenting with type 1 diabetes. The aim is to test whether the diabetes vaccine can prevent or delay the onset of type 1 diabetes in the children.
New concept with the Diamyd® diabetes vaccine approved for testing in children and adolescents with type 1 diabetes
The Swedish Medical Products Agency has approved another new researcher-initiated combination study with the Diamyd® diabetes vaccine. In the study, Diamyd® will be combined with two other agents – vitamin D and the immunosuppressive drug etanercept. This was the fourth researcher-initiated clinical trial with the Diamyd® diabetes vaccine to receive regulatory approval in the autumn of 2014. Two other clinical studies with the diabetes vaccine are already ongoing.
Diamyd-licensed technology enhances transplanted human beta cell mass in preclinical model of type 1 diabetes
A new scientific paper in the December issue of the journal Diabetes shows that GABA enhances transplanted human beta cell mass in the NOD mouse model of type 1 diabetes. Diamyd Medical licenses exclusive rights from the University of California for the therapeutic use of GABA for the treatment of diabetes and other inflammation-related conditions.
Significant events after the reporting period
Diamyd Medical’s patent protection extended to 2032 in pivotal decision
The Regents of the University of California on behalf of its Los Angeles Campus (UCLA) has been granted another key US patent for its GAD65 technology on which the Diamyd® diabetes vaccine is based. The term of the new patent runs into 2032, which is approximately ten years longer than current US patents. Diamyd Medical is the exclusive licensee to the new patent.
About the Diamyd® diabetes vaccine
Diamyd® is being developed with the objective of preventing, delaying or stopping the autoimmune attack on beta cells in type 1 diabetes and other forms of autoimmune diabetes and thus preserve the body’s own ability to produce insulin. Ongoing development work is aimed at enhancing the efficacy of the treatment by combining Diamyd® with other agents and to treat earlier in the disease process. New approaches are being evaluated in several clinical studies together with different teams of researchers. Two researcher-initiated clinical studies with Diamyd® are ongoing and an additional four are being launched.
- DIABGAD-1. A placebo-controlled study, where Diamyd® is being tested in combination with ibuprofen and vitamin D. The study comprises a total of 64 patients between the ages of 10 and 18 recently diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the combination treatment is to preserve the body’s residual capacity to produce insulin. All of the participants have been enrolled in the study and the initial six-month results, focusing on immunological markers, are expected to be presented in the spring of 2015. The study runs at nine clinics in Sweden and is led by Professor Johnny Ludvigsson at Linköping University.
- DIAPREV-IT. A placebo-controlled study, where Diamyd® is being tested in children with early stages of type 1 diabetes, meaning that they have been found to have an ongoing autoimmune process but do not yet have any clinical symptoms of diabetes. A total of 50 participants from the age of four have been enrolled in the study, which will last for five years. The aim of the study is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. The study is taking place in Sweden led by Dr. Helena Elding Larsson at Lund University. Results are expected at the end of 2016.
- DIAMYD®/GABA. A placebo-controlled study, where Diamyd® is being tested in combination with GABA. The study will comprise 75 patients between the ages of 4 and 18 recently diagnosed with type 1 diabetes, and will continue for a total of 12 months. The aim of the combination treatment is to preserve the body’s residual capacity to produce insulin. The study is taking place in the US led by Professor Kenneth McCormick at the University of Alabama at Birmingham and is in the start-up phase.
- DIAPREV-IT 2. A placebo-controlled study, where Diamyd® is being tested in combination with vitamin D in children with early stages type 1 diabetes, meaning that they have been found to have an ongoing autoimmune process but do not yet have any clinical symptoms of diabetes. A total of 80 participants between the ages of 4 and 18 will be enrolled in the study, which will last for five years. The aim of the study is to evaluate whether Diamyd® can delay or prevent the participants from presenting with type 1 diabetes. The study is taking place in Sweden led by Dr. Helena Elding Larsson and is in the start-up phase.
- DIAGNODE. An open label study, where Diamyd® is administered directly into lymph nodes in combination with treatment with vitamin D. The study will comprise five patients between the ages of 18 and 30 who have been newly diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the study is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The study is taking place in Sweden led by Professor Johnny Ludvigsson and is in the start-up phase.
- EDCR IIa. An open label study, where Diamyd® is combined with etanercept and vitamin D. The study will comprise 20 patients between the ages of 8 and 18 who have been newly diagnosed with type 1 diabetes, and will continue for a total of 30 months. The aim of the study is to evaluate the safety of the combination treatment and the effect on the immune system and the patients’ insulin producing capacity. The study is taking place in Sweden led by Professor Johnny Ludvigsson and is in the start-up phase.
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