New study to prevent type 1 diabetes with the Diamyd® diabetes vaccine approved by the Swedish Medical Products Agency on World Diabetes Day
Diamyd Medical (Nasdaq Stockholm First North, Ticker: DMYD B) informs that today, on World Diabetes Day, the Swedish Medical Products Agency 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.
Type 1 diabetes starts long before the appearance of any clinical symptoms of the disease. The most recent research concludes that there are two early stages of type 1 diabetes, prior to clinical onset, during which the immune system has already started to attack the insulin producing cells in the body, but there are not yet any noticeable symptoms. It is however possible to detect that the autoimmune process has started by screening for certain markers in the blood. In large screening studies at Lund University, Sweden, children with these markers have been identified and those children will thus most probably present with symptomatic type 1 diabetes at some point in their life. If treatment with the diabetes vaccine in combination with Vitamin D can stop this autoimmune process, the onset of symptomatic type 1 diabetes could be prevented or delayed in these children.
“Since we know these children will likely present with symptomatic type 1 diabetes sooner or later, it is very satisfying to be able to offer them something to try to stop or delay the disease process,” says Helena Elding Larsson, pediatrician in Malmö and researcher at Lund University but also the lead investigator and sponsor for the new study.
“To halt the autoimmune attack against the insulin producing cells early in the type 1 diabetes disease process would be the ultimate goal,” says Åke Lernmark, Professor of Experimental Diabetes Research at Lund University. “Then, one might actually be able to prevent that these children present with full-blown type 1 diabetes with all of its implications, such as daily insulin injections and blood tests.”
“The now approved clinical study means that the diabetes vaccine will be made available to more children who most probably will present with symptomatic type 1 diabetes, both prior to and following any diagnosis,” says Anders Essen-Möller, Chairman of Diamyd Medical. “This could shorten the path to market acceptance.”
The new study, DiAPREV-IT 2, is a complement to the ongoing study DiAPREV-IT. The participants in the new study will also be supplemented with vitamin D with the aim of strengthening the efficacy of the Diamyd® diabetes vaccine. The study will stratify the participants according to which early stage of type 1 diabetes they are in at the start of the study. The first stage comprises children with two or more auto-antibodies directed at their own insulin-producing cells, but with normal glucose metabolism. The second stage comprises children with both auto-antibodies and impaired glucose metabolism. Vitamin D supplement is given to down-regulate the immune system’s inflammatory components in order to increase the diabetes vaccine’s tolerance-inducing effect regarding the preservation of the body’s insulin-producing capacity.
The study is double-blind and placebo-controlled. Half of the participants will be randomized to receive two injections of Diamyd® and half will be randomized to receive placebo (non-active substance), but no one will know which treatment group they are randomized to until the study is completed after 5 years. The children that present with symptomatic type 1 diabetes during the study will receive injections of active Diamyd® after diagnosis, regardless of what they received as preventative treatment. This way, the effect of the diabetes vaccine can be monitored also in new-onset patients.
DiAPREV-IT and DiAPREV-IT 2 are conducted by a research team at Lund University and funded by research grants. Diamyd Medical is providing the study drug and has participated in the design of the studies and is also able to utilize the findings of the studies.
About type 1 diabetes
Type 1 diabetes is an autoimmune disease where the immune system attacks the patients’ own insulin producing beta cells. By analyzing markers in the blood it is possible to identify persons in whom this autoimmune process is ongoing, although has not yet caused clinical symptoms of diabetes. When type 1 diabetes presents with clinical symptoms, patients must be treated daily, for the rest of their lives, with insulin to sustain life. The importance of finding a cure is high for the world’s health care systems and the wellbeing of patients. The annual market for an easy to use, successful therapeutic is estimated to several billion dollars.
About Diamyd Medical
Diamyd Medical is dedicated to fight type 1 diabetes and to work towards a cure for the disease. Diamyd Medical’s current projects include development of combination regimens for arresting the successive destruction of insulin producing beta cells using the Company’s GAD65-based diabetes vaccine Diamyd®, such as Diamyd® + Vitamin D with or without an anti-inflammatory compound; and Diamyd® combined with GABA, for which Diamyd Medical licenses exclusive intellectual rights from the University of California in Los Angeles (UCLA). Diamyd Medical has further acquired 46% of the stem cell company Cellaviva AB that is establishing a Swedish commercial bank for private family saving of stem cells in umbilical cord blood and other sources of stem cells. Stem cells are required for Personalized Regenerative Medicine (PRM), for example to restore beta cell mass in diabetes patients where autoimmunity has been arrested.
Remium Nordic AB is the Company’s Certified Adviser.
For further information, please contact:
Anders Essen-Möller, Chairman Diamyd Medical AB
Phone: +46 70 55 10 679. E-mail: email@example.com
Diamyd Medical AB (publ)
Kungsgatan 29, SE-111 56 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68
E-mail: firstname.lastname@example.org. Reg. no.: 556242-3797. Website: www.diamyd.com.