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STOCKHOLM, December 16, 2020 / PRNewswire / – Diamyd Medical and the Critical Path Institute (C-Path) are proud to announce their collaboration to dramatically improve the scientific community’s knowledge of type 1 diabetes (T1D) through Diamyd Medical’s contribution of fully anonymized data from ” a European phase III trial to the outcome of the Measures Initiative’s Integrated T1D Database (TOMI) trial.
The phase III trial evaluated the use of the Diamyd diabetes vaccine®, an antigen-specific immunotherapy based on the autoantigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin-producing cells. The Data Contribution Agreement between Diamyd Medical and C-Path will integrate this unique, fully anonymized clinical trial data set into an ever-growing list of trial data sets committed to the TOMI-T1D project. .
TOMI-T1D is an international partnership between universities, the pharmaceutical industry and non-profit organizations. It is funded by the world’s leading diabetes research charities, JDRF and Diabetes UK, guided by the two organizations’ strong commitment to facilitate in-depth querying of community-wide consolidated trial data to accelerate clinical research and therapeutic development for T1D. TOMI-T1D aims to create a Clinical Trial Simulation Tool (CTST) with large and diverse clinical data sets from the T1D community. The project also seeks to engage the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory approval of these drug development tools.
Diamyd Medical’s data includes relevant information on disease progression, drug effects, and clinical trial design. The contribution of these strong data sets from industry-led trials is essential to TOMI-T1D’s work in developing innovative, quantitative tools that can facilitate clinical development efforts and be approved by regulators for further development. future use by the pharmaceutical industry to optimize the design of future clinical trials.
“Progress towards the implementation of approved therapies for people with T1D depends largely on the participation of our industry partners with their data,” said Simi ahmed and Elizabeth robertson, on behalf of the charitable partnership.
“It is indeed a good step in that direction,” said Colin Dayan, Principal Investigator at Cardiff University.
“We are delighted that Diamyd Medical is playing a leadership role and championing precompetitive collaborations to advance scientific solutions for the regulation of type 1 diabetes,” said Inish O’Doherty, Executive Director of C-Path. “Their data will help in the construction and evaluation of a clinical trial simulation tool to aid in the development of new therapies for type 1 diabetic patients.”
“We are very honored to be a part of this important collaboration – involving key stakeholders in the type 1 diabetes landscape,” said Ulf Hannelius, President and CEO of Diamyd Medical. “As we enter an era of precision medicine in type 1 diabetes, we can expect to see significant therapeutic advances, and access to high-quality data will be integral to maximizing these efforts.” .
To learn more about the TOMI-T1D project, visit: https://c-path.org/programs/tomi-t1d/
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, thereby accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia which currently include more than 1,600 scientists from government and regulatory agencies, universities, patient organizations, disease foundations and dozens of pharmaceutical and biotechnology companies. C-Path US is headquartered at Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in several other locations. For more information, visit c-path.org and c-path.eu.
About JDRF
JDRF’s mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To do this, JDRF has invested more than $ 2.5 billion in research funding since our creation. We are an organization built on a core model of people connecting in their local communities, collaborating regionally for effectiveness and wider impact in fundraising, and coming together on a national stage to pool together resources, passion and energy. We collaborate with academic institutions, policy makers, and business and industry partners to develop and deliver a pipeline of innovative therapies to people with T1D. Our staff and volunteers everywhere United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, visit jdrf.org or follow us on Twitter: @JDRF
About Diabetes UK
1. Diabetes UK’s goal is to create a world where diabetes can’t hurt. Diabetes is the most devastating and fastest growing health crisis of our time, affecting more people than any other serious health problem in the UK – more than dementia and cancer combined. There is currently no known cure for any type of diabetes. With the right treatment, knowledge and support, people with diabetes can lead long, full and healthy lives. For more information on diabetes and the association’s work, visit www.diabetes.org.uk
2. Diabetes is a condition where there is too much glucose in the blood because the body cannot use it properly. If not well managed, type 1 and type 2 diabetes can lead to devastating complications. Diabetes is one of the leading causes of preventable sight loss in working age people in the UK and is a major cause of lower limb amputation, kidney failure and stroke.
3. People with type 1 diabetes cannot produce insulin. About 10 percent of people with diabetes are type 1. No one knows exactly what causes it, but it’s not related to being overweight and it’s currently not preventable. It is the most common type of diabetes in children and young adults, which starts suddenly and gets worse quickly. Type 1 diabetes is treated with daily doses of insulin – taken by injection or through an insulin pump. It is also recommended to follow a healthy diet and practice regular physical activity.
4. People with type 2 diabetes do not make enough insulin or the insulin they produce does not work properly (called insulin resistance). About 90 percent of people with diabetes are type 2. They may have type 2 diabetes because of their family history, age and ethnicity that put them at increased risk. They are also more likely to develop type 2 diabetes if they are overweight. It starts gradually, usually later in life, and it can take years before they realize they have it. Type 2 diabetes is treated with a healthy diet and increased physical activity. Additionally, tablets and / or insulin may be needed.
For more information on diabetes reporting, download our Journalists Guide: Diabetes in the News: A Journalist’s Guide to Diabetes Reporting (PDF, 3MB).
About Diamyd Medical
Diamyd Medical is developing therapies for type 1 diabetes. The Diamyd diabetes vaccine® is an antigen-specific immunotherapy for the preservation of endogenous insulin production. Significant results were shown in a genetically predefined group of patients in a large-scale metastude as well as in the European phase IIb trial of the company DIAGNODE-2, where the diabetes vaccine is administered directly into a lymph node in newly diagnosed children and young adults. type 1 diabetes. A new vaccine manufacturing plant is being established in Umeå for the manufacture of recombinant GAD65, the active ingredient in the therapeutic diabetes vaccine Diamyd®. Diamyd Medical is also developing GABA-based investigational drug Remygen® as therapy for the regeneration of endogenous insulin production and for improving the hormonal response to hypoglycemia. A Remygen initiated by an investigator® a trial in patients with type 1 diabetes for more than five years is underway at Uppsala University Hospital. Diamyd Medical is a major shareholder of the stem cell company NextCell Pharma AB.
Diamyd Medical’s B share trades on the Nasdaq First North Growth Market under the symbol DMYD B. FNCA Sweden AB is the company’s certified advisor; phone: +46 8-528 00399, e-mail: [email protected]
CONTACT:
For more information, please contact:
Ulf Hannelius, President and CEO
Phone: +46736 35 42 41
E-mail: [email protected]
This information was provided to you by Cision http://news.cision.com
https://news.cision.com/diamyd-medical-ab/r/diamyd-medical-and-critical-path-institute-announce-data-sharing-collaboration-to-develop-advanced-d,c3255392
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