Stockholm, June 14, 2003
DIAMYD REPORTS SUCCESSFUL CLINICAL PHASE II TRIAL WITH DIABETES VACCINE
Diamyd Medical AB, publicly traded on the Stockholm Stock Exchange in Sweden (O-list), today reported a positive outcome from a phase II trial with its GAD-based diabetes vaccine Diamyd™. The results may lead to a new treatment to prevent type 1 diabetes.
The presentation of the results took place at the American Diabetes Association (ADA) convention in New Orleans, by Dr. Åke Lernmark, University of Washington, Seattle. "My opinion is that this phase II study has been tremendously successful", says Åke Lernmark "Not only is it now shown that the Diamyd™ vaccine can be safely administrated in a wide range of doses, but a clear and significant positive effect (P=0.01) of the vaccine was found at one of the dose levels six months from first vaccination. It is also important to note that the trial was conducted to the highest standards which ads further weight to its results."
"We could not have hoped for better results. The Diamyd™ vaccine is safe and we have an effective dose to go on with", says Anders Essen-Möller, President and CEO of Diamyd Medical.
In type 1 diabetes, the immune system mistakenly destroys the insulin-producing cells in the pancreas in an autoimmune attack. Over time, this attack leads to a lack of insulin, the hormone that controls blood sugar levels. People with type 1 diabetes must inject insulin daily.
In type 2 diabetes, patients normally continue to produce their own insulin but are less sensitive to it. Therefore these patients may be treated with tablets to increase their sensitivity to insulin. A large group (about 10%) of the type 2 diabetes patients have antibodies to GAD. These patients are called LADA and suffer from a similar autoimmune attack as the type 1 diabetes patients, which leads to the need for insulin injections.
Diamyd Medical conducted the phase II clinical trial by vaccinating patients with recently diagnosed LADA. The GAD-vaccine successfully improved these patients´ C-peptide levels and therefore their ability to make insulin over a six-month period, compared with patients who received a placebo.
"The study shows that the vaccine is safe and that it is possible to inhibit the autoimmune attack on the cells that make insulin, thereby slowing the progression of the disease", said Essen-Moller.
The vaccine to prevent type 1 diabetes arose from experiments with diabetes prone-mice that were protected from developing the disease by injecting GAD-protein. "It´s tremendously satisfying to see our work at UCLA go from the lab to a clinical application with the potential to help so many people" said Daniel Kaufman, Ph.D., Professor, UCLA Department of Molecular and Medical Pharmacology, whose research team was first to develop and test a GAD-vaccine in diabetes-prone mice.
Diamyd Medical´s phase II trial was conducted on 47 diabetes patients with the GAD-based vaccine Diamyd™ at the UMAS hospital in Malmoe and St.Gorans Hospital in Stockholm, Sweden. The patients were randomly divided into four groups with 12 patients in each group. Each patient received one first injection of Diamyd™ followed by at least one boost injection four weeks after. Nine patients in every group received active drug whereas three received placebo. The groups received different doses of the vaccine ranging from 4 to 500 micrograms per dose. All patients visited the hospitals 10 times during this six-month study, and detailed clinical, immunological as well as neurological investigations showed no safety concerns at the administered dose levels.
The study results show that the diabetes vaccine significantly improves the serum C-peptide levels both at fasting (P=0.01) and after meals (P=0.02) at one of the doses.
"Since the vaccine seem effective when given to people with an advanced disease, we are hopeful that it will be highly effective when given at earlier stages of the disease process - we now know that type 1 diabetes takes years to develop and that we can detect people who are at early stages of the disease process by testing for GAD autoantibodies in their blood" said Essen-Moller.
"We will now continue to analyze the results from this study", says Essen-Möller. "The future for the Diamyd™ diabetes vaccine is promising".
Diamyd Medical is identifying and developing therapeutic candidates through phase II. The Company´s intention is thereafter to seek co-operation with established pharmaceutical companies for further development. Diamyd Medical is pursuing various GAD-based development projects of which the GAD-based diabetes vaccine Diamyd™ is the most advanced at this time. Diamyd Medical has licensed exclusive and worldwide intellectual rights for therapeutic use of GAD from the Universities of California in Los Angeles and University of Florida in Gainesville, Florida.
The first application for Diamyd™ is older patients with adult onset diabetes with GAD antibodies since this patient group progress to full insulin dependence within a few years. The market for this application may be in the area of one billion US dollars per year. Future studies will address whether the vaccine can also prevent the development of type 1 diabetes in young people that have not yet developed the disease. With the availability of a potential therapeutic, the pre-diagnostic tests for who is at risk for developing the disease (based on the detection of antibodies to GAD and other islet proteins), becomes quite valuable. Diamyd has an extensive array of pre-diagnostic kits for detecting autoantibodies to these proteins. Additional possible applications of the vaccine are to prevent recurrent autoimmune diabetes after transplantation of islet cells and stem cell therapy.
About Diamyd Medical:
Diamyd Medical’s business idea is to identify and develop pharmaceutical projects up to and including Phase II. At present Diamyd Medical is running a number of GAD-based development projects and has the licensed rights for this from universities in the US.
For further information, please contact:
Johannes Falk, Diamyd Medical AB (publ),
Phone: +46 8-661 00 26, +46 8-661 12 25,
fax: +46 8-661 63 68, or via e-mail: firstname.lastname@example.org.
No guarantee is given or implied for the accuracy of any statements on present, historical or future results.