A drug for Type 1 diabetes meets primary and secondary goals of Phase III clinical trials
Posted: 23 November 2011 | | No comments yet
The clinical trial was random, regulated, double-blinded and broad-based…
Professor Irun Cohen, Weizmann Institute
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.
Professor Irun Cohen, Weizmann Institute
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
The Weizmann Institute of Science in Rehovot, Israel, is one of the world’s top-ranking multidisciplinary research institutions. Noted for its wide-ranging exploration of the natural and exact sciences, the Institute is home to 2,700 scientists, students, technicians and supporting staff. Institute research efforts include the search for new ways of fighting disease and hunger, examining leading questions in mathematics and computer science, probing the physics of matter and the universe, creating novel materials and developing new strategies for protecting the environment.
