At the beginning of June, the final participants were included in the researcher-initiated study DIABGAD-1 following intensive and successful recruitment efforts. Slightly more than 60 children and adolescents with newly diagnosed type 1 diabetes are participating in the study and testing our diabetes vaccine, Diamyd®, in a unique combination with vitamin D and ibuprofen. We strongly believe in attacking the disease process in type 1 diabetes from several angles simultaneously by combining Diamyd® with other drugs and this is one of the first such studies anywhere in the world. The Phase II study will also evaluate the effect of a double dose of Diamyd®. The aim of the treatment is to preserve the patients’ endogenous insulin production. Now that the last participant has been treated, we know that the first planned analysis focusing on immunological markers can be initiated at the end of 2014 and, accordingly, the results presented at the start of 2015.
The study is being led by Professor Johnny Ludvigsson at Linköping University. Professor Ludvigsson is ranked as one of the world’s ten most distinguished researchers of type 1 diabetes according to a recent analysis based on scientific publications in the field over the last ten years. Professor Mark Atkinson, who is a member of Diamyd Medical’s Scientific Advisory Board, is found at second place in the top-ten list and Diamyd Medical also collaborates with several other top names. The list was published in June at the annual US diabetes conference that was held in San Francisco and which brought together over 17,000 participants. As usual, Diamyd Medical was there to network and to discuss possibilities for future collaborations.
At the same time, there is an ongoing researcher-initiated pilot study with Diamyd®, called DiAPREV-IT, which is testing whether the diabetes vaccine can prevent or delay type 1 diabetes in healthy children who are at high risk of developing the disease. Simply delaying the onset of the disease with the help of the diabetes vaccine would be a major medical success. The pilot study currently comprises 50 children aged four and upwards and the research team at Lund University conducting DiAPREV-IT would like to test the concept on more children to increase the probability of being able to demonstrate a statistically significant preventive effect of the diabetes vaccine. The research team is in discussions with the Swedish Medical Products Agency and Diamyd Medical about the most appropriate way of increasing the sample size by means of additional children.
Efforts continue to launch additional researcher-initiated clinical trials with Diamyd® and we have well-advanced plans in place with several teams of researchers.
In April, we invested in two exciting startups. The first and largest investment was in Sweden’s first commercial stem cell bank for private family saving of umbilical cord blood and other sources of stem cells. Diamyd procured a 46-percent holding for an investment of MSEK 11.5. The company has taken the name Cellaviva and is in the process of establishing its operations in close proximity to Karolinska Institutet's cell therapy and regenerative medicine programs.
The second investment was in Companion Medical, a newly started medical technology company in San Diego, in the US, which develops advanced technical devices for people living with insulin-treated diabetes. For competitive reasons, Companion Medical does not want us to reveal exactly what it is developing, more than that it comprises a cost-effective system combining the best features of existing solutions for delivering insulin to the body together with advanced data management. It was our presence in the global diabetes world that generated the opportunity for us to invest in Companion with its highly skilled and experienced team. In addition to a ten-percent ownership stake, Diamyd Medical also gains the distribution rights for its future products in the Nordic region. The investment makes it possible to broaden our diabetes portfolio in the long term and to enter the medical technology market.
Stockholm, July 2, 2014
President and CEO Diamyd Medical AB (publ)