Summary of Safety Data
The safety of DiaPep277® was extensively evaluated by preclinical toxicology including chronic administration studies, studies in juvenile animals, and fertility and reproductive studies. The drug was well-tolerated and showed no toxicity or significant adverse effects. No immunological toxicity or immune compromise was observed after repeated dosing.
In clinical studies, more than 300 patients including children and adults have been treated with repeated doses of DiaPep277®. The drug has been found to be well tolerated without any clinical or immunological safety concerns.
The safety profile of the drug is being continually monitored by an Independent Data Monitoring Committee (IDMC) to carefully assess the risk/benefit of the treatment.
Summary of Efficacy Data
Several phase II studies were conducted to evaluate the ability of DiaPep277® to preserve insulin secretion in type 1 diabetes patients. The results of these studies clearly demonstrate preservation of beta cell function following treatment compared to a control, untreated group.
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In addition, a higher percentage of patients in the treatment group than in the control group reached a target of glycemic control of HbA1c < 7%.
