Time magazine reported in its January 16, 2001 issue that a drug derived from modified cobra venom might be tested at Canadian MS clinics as a treatment for MS in the near future.
Immunokine has been tried in 25 people with MS under non-placebo controlled conditions with initial encouraging results. Phylomed, the Florida company that makes the drug, has applied to Health Canada to test it at several Canadian MS clinics. Additional details will be provided when they become available.
The study of Immunokine was a Phase I trial. This is a short study in which both the people receiving the therapy and the study investigators know the participants are receiving active treatment. The primary outcome is to test for safety of the therapy.
The usual next step would be a Phase II trial in which participants are divided into groups. One group receives active treatment and one receives a placebo (non-active) treatment. Neither the participants nor the physicians who examine them know who is taking which treatment until the code is broken at the end of the study. This is called a double-blind, placebo controlled study. The investigators start to gather data on whether the therapy actually works while still measuring safety.
If results from the Phase II study are positive, the next stage is a Phase III trial. It is a double-blind, placebo controlled study that involves a large number of people, often at many research sites for a number of months. It collects data on safety, the effectiveness of the therapy and side effects. These data are necessary for any submission to Health Canada for evaluation of a therapy for potential approval.
Prepared by National
Communications and Social Action Department