Application to double unique study with Diamyd’s diabetes vaccine submitted to the Swedish MPA
The research group at Lund University, that runs DiAPREV-IT, a clinical study evaluating if the diabetes vaccine Diamyd® can prevent or delay the onset of type 1 diabetes in children at high risk of developing the disease, has applied to the Swedish Medical Products Agency to expand the study with an additional 50 children. The first part of the study, which also comprises 50 children, is fully recruited and results are expected in 2015.
“To expand this unique study is important as the chance to demonstrate a statistically significant effect of Diamyd’s diabetes vaccine increases the more children that are enrolled in the study,“ says Peter Zerhouni, President and CEO of Diamyd Medical. “Type 1 diabetes is a lifelong and serious disease and if it could be prevented or delayed it would avoid a lot of worrying, suffering and costs for the children and their families as well as for the society. There is no treatment available today that can prevent or delay the disease process.”
DiAPREV-IT, which was started in 2009, is a double-blind and placebo-controlled clinical study which to date has enrolled 50 children from four years of age. Half of the children have been treated with the diabetes vaccine Diamyd® and half with placebo (a non-active substance). The children are currently in follow-up and the first results of the study are expected in 2015.
The Sponsor and Principal Investigator of the study, Helena Elding Larsson, pediatrician in Malmoe and researcher at Lund University in Sweden, has now applied to the Swedish Medical Products Agency to enroll an additional 50 children at high risk of developing type 1 diabetes. In the expanded part of the study two thirds of the children are planned to receive active diabetes vaccine and one third placebo. When the 50 new children have been in the study for three years the results of all 100 children are planned to be pooled and analyzed.
”The scientific value of the study will be much enhanced if we can double the number of participants,” says Doctor Helena Elding Larsson. “Also, it is fantastic to be able to offer something to these children that we know, by analyzing their genetic risk and biomarkers in their blood, are at high risk of developing type 1 diabetes. Half of them are expected to present with the disease within only five years. Just delaying the disease with the help of the diabetes vaccine would represent a medical breakthrough.”
In addition to the DiAPREV-IT study described above, the enrollment of patients to another researcher initiated Phase II study with the diabetes vaccine Diamyd® is underway at around ten pediatric diabetes clinics across Sweden. In that study, called DIABGAD-1, children and adolescents recently diagnosed with type 1 diabetes are treated with the diabetes vaccine Diamyd® in combination with vitamin D and ibuprofen. That study aims to investigate whether the treatment can preserve the body’s capacity to make insulin. Some insulin producing capacity reduces the risk of both acute and long-term diabetes complications. The first results from DIABGAD-1 are expected to be presented in 2015.
About Type 1 Diabetes
Type 1 diabetes is an autoimmune form of diabetes that ordinarily occurs in children. The disease is caused by an autoimmune attack, which means that the body’s own immune system destroys the insulin-producing beta cells in the pancreas that control the blood sugar. To survive with type 1 diabetes intensive treatment with insulin is needed every day for life, either through injections or an insulin pump, and the blood sugar must be checked through blood samples 7-10 times a day. Both too much and too little insulin can lead to unconsciousness and even death. Type 1 diabetes can also cause serious long-term complications, such as blindness, cardiovascular disease, nephropathy and neuropathy. Today there is no cure for type 1 diabetes and the disease cannot be prevented.
It is estimated that approximately 80,000 persons per year are diagnosed with type 1 diabetes in the US and Europe alone. The Nordic countries have the highest incidence of type 1 diabetes in the world. In Sweden two children are diagnosed with type 1 diabetes every day.
For further information, please contact:
Peter Zerhouni, President and CEO Diamyd Medical AB
Phone: +46 8 661 00 26. E-mail: press@diamyd.com
About Diamyd Medical
Diamyd Medical is a Swedish diabetes company. The Company’s primary development project consists of the GAD-based diabetes vaccine Diamyd®for the treatment and prevention of autoimmune diabetes. Two Swedish researcher-initiated Phase II studies with Diamyd®are ongoing. One study evaluates whether the diabetes vaccine can prevent type 1 diabetes in children who are at high risk of developing the disease, while the other study evaluates whether Diamyd®in combination with vitamin D and ibuprofen can preserve the body's own ability to regulate the blood sugar level in children and adolescents newly diagnosed with type 1 diabetes.
In May 2013 the Company concluded an exclusive licensing agreement with the University of California in Los Angeles (UCLA) relating to a patent portfolio for the therapeutic use of GABA (gamma-aminobutyric acid) and GABA receptor agonists for the treatment and prevention of type 1 and type 2 diabetes and other inflammation-related conditions, such as metabolic syndrome, rheumatoid arthritis and allergies.
Diamyd Medical also has holdings in the gene therapy company Periphagen Holdings, Inc. (US).
Diamyd Medical’s Series B share is traded on NASDAQ OMX First North under the ticker DMYD B. Remium Nordic AB is the Company’s Certified Adviser. Further information is available on the Company’s website: www.diamyd.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: info@diamyd.com. Reg. no.: 556242-3797.
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