The clinical trial was random, regulated, double-blinded and broad-based. The drug was tested on 457 patients, aged 16-45, who had been diagnosed with Type 1 diabetes a short time before joining the trial. The trial took place in around 40 medical centers in Europe, Israel and South Africa. The patients in the trial were randomly assigned to one of two groups: One received the trial drug (DiaPep277®) through a subcutaneous injection once every three months, for a period of two years, while the control group was given a placebo in the same way. In addition, all of the patients received insulin as needed to stabilize their glucose levels.
DiaPep277® was invented by Prof. Irun Cohen
and his team at the Weizmann Institute of Science. This unique peptide, containing 24 amino acids, is derived from the sequence of the human heat shock protein 60 (Hsp60). The peptide acts by modulating the immune system, preventing the destruction of the pancreatic cells that secrete insulin and preserving their natural function. Treatment of Type 1 diabetes patients with DiaPep277® may have several medical benefits: slowing the deterioration of the diseased tissue, improved metabolic control, a reduction in daily insulin requirements and fewer complications of diabetes.
During the trial, the ability of the patients’ pancreas to secrete insulin was tested. From an initial analysis of the results, it appears that the patients treated with the drug for a year or more had significantly higher pancreas function than those in the control group.
From the point of view of safety, no significant differences were found in the incidence of side effects between the treated and control groups.
Additional data on the drug’s efficacy and safety were collected and evaluated, and these will be presented in a final report on the trial, which will be completed in several months.
Andromeda Biotech is now planning to conduct another trial, to try to reproduce these results. Recruitment of patients into this trial is expected to be finalized in the second quarter of 2012.
The research and development team of Andromeda Biotech emphasize that the drug is still under development, and there is no absolute guarantee that the drug will eventually be marketed.
Prof. Irun Cohen’s research is supported by the Laszlo N. Tauber Family Foundation