STOCKHOLM, Sweden, Nov. 24, 2003 (PRIMEZONE) -- Diamyd Medical (O-list) is developing the Diamyd(TM) pharmaceutical for insulin dependent diabetes. In the Annual Report for the financial year 02/03, which is being published this afternoon, November 24, on the Company's web site www.diamyd.com, Director of Research and Development Dr. John Robertson reports on the successful result of the Phase II study carried out with the pharmaceutical. Dr. Robertson describes the unexpected and sensational finding that the pharmaceutical Diamyd(TM) increases the levels of C-peptide in diabetes patients rather than just slowing down their decrease as was expected. This indicates that treating patients with Diamyd(TM) results in an improved environment for their beta cells allowing them to produce more insulin. It may also indicate that the insulin producing cells are being regenerated.
The Phase II study included several methods for evaluating clinical safety -- one was to check the effect the pharmaceutical had on the status of the illness in diabetes patients by measuring levels of C- peptide. Furthermore, patients were treated with widely varying doses of the pharmaceutical to be able to identify an effective dose. Apart from being able to prove that the substance was safe, researchers hoped to be able to show that one of the doses would prevent the levels of C-peptide continuing to decrease thus having a braking effect on the development of the disease.
Decreasing levels of C-peptide are an indication of the onset of insulin- dependent diabetes. It was when analyzing these values that the sensational discovery was made that patients being treated with a 20ug dose showed a dramatic increase in the level of C-peptide in the blood. These results were also confirmed statistically.
"So, instead of having a braking effect on the development of the disease as we had hoped, it is clear that Diamyd(TM) has helped increase C-peptide levels," says Diamyd Medical's Director of Research and Development Dr. Robertson. "This could indicate that treatment with Diamyd(TM) can result in beta cells being regenerated and with them an increase in the production of C-peptide."
The result of the pharmaceutical causing the greatest increase of C- peptide levels in one of the doses investigated is natural and to be expected as a narrow treatment spectrum is also the case in the antigen treatment of certain allergies. That only one dose level works in antigen treatments has often been shown in animal models when researchers have studied immune various pharmaceuticals. This is why Diamyd Medical's researchers chose from the beginning to use four doses over a wide spectrum in order to identify the dose that has an effect in this type of antigen-specific immunomodulation.
Diamyd Medical has started the process of finding a partner for further commercialization of Diamyd(TM).
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