Diamyd Medical has made a flying start to the autumn and the company is a hive of activity. Among all these activities, we will manufacture fresh GAD protein at our long-term partner Protein Sciences Corporation. The GAD protein is the active substance in the diabetes vaccine Diamyd®, which is being developed for the treatment and prevention of autoimmune diabetes. Since a portion of the payment is being made in Diamyd shares, Protein Sciences will become a strategic and one of the largest shareholders in Diamyd Medical. Having a well-established manufacturing process for Diamyd® in place represents a substantial value and further deepening the relationship with Protein Sciences in this manner is very positive for ensuring long-term manufacturing.
We are meeting increasing interest for conducting studies with the diabetes vaccine so it is strategically important that we keep the production process updated and, continuously, ensure that GAD protein and ready-for-use Diamyd® are available for clinical trials. Diamyd® is the Antigen-Based Therapy (ABT) that is at the forefront of development and can be used on children due to its favorable safety profile demonstrated in extensive earlier clinical trials. Together with researchers, we strongly believe in attacking the disease process for type 1 diabetes from several angles simultaneously by combining Diamyd® with other drugs and we are preparing such combination trials together with half a dozen different groups. The preparations for several of these have progressed as far as discussions with the regulatory authorities.
A new investigator-initiated trial with Diamyd® recently received approval from the Swedish Medical Products Agency and is being launched. In analogy to the development in allergy therapy, where the administration of allergen into lymph nodes significantly improved the efficacy, in this study, a low dose of Diamyd® will be administered directly into lymph nodes in combination with vitamin D treatment. Initially, this exciting concept will be tested on a small group of adult patients recently diagnosed with type 1 diabetes. The entire study will be conducted at Linköping University under Professor Johnny Ludvigsson.
Another investigator-initiated combination trial where discussions are ongoing with the US Food and Drug Administration (FDA) pertains to the combination of Diamyd® and gamma amino butyric acid (GABA). Last year, Diamyd Medical secured a license from the University of California, Los Angeles (UCLA) to the exclusive intellectual rights for GABA for the treatment of diabetes, among other conditions. The idea of combining GABA with Antigen-Based Therapy (ABT) for type 1 diabetes gained further support from a scientific paper at the beginning of September. In the paper, scientists at UCLA confirmed previous findings, that combination therapy with GABA and ABT acts synergistically when treating non-obese diabetic (NOD) mice, a model for type 1 diabetes. The new paper concludes that the use of GABA in combination with ABT also has potential for type 1 diabetes intervention in humans.
In parallel with the planning of new trials, one of the world’s first combination trials is ongoing in Sweden – DIABGAD-1. Slightly more than 60 children and adolescents with newly diagnosed type 1 diabetes are participating in the trial and testing Diamyd® in a unique combination with vitamin D and ibuprofen. The trial received a nice contribution corresponding to about SEK 1.1 million in EU funding at the end of August. The expectation is to be able to present the results from the first six months of the trial at the start of 2015 with a focus on immunological markers. Later in 2015, the 15-month results should also be available from the trial and these will be able to say more about the effects of the treatment on the patients’ ability to produce their own insulin.
Having widened the Company’s focus areas during the fiscal year through investments in the Swedish company Cellaviva, which is establishing a bank for umbilical cord blood and stem cell research, and the US medical technology company Companion Medical, we are now looking to leverage the increasing interest in Diamyd® and investing energy in identifying collaboration partners.
Stockholm, October 15, 2014
President and CEO Diamyd Medical AB (publ)