The clinical trial, which is being undertaken at Maisonneuve-Rosemont Hospital in Montreal, will consist of 30 patients in two cohorts.
Each cohort will receive PBI-1402 or placebo for two months and, in the case of favorable results, the treatment may be extended for up to another four months. The first cohort will receive PBI-1402 at a dose suggested by the phase I trial and this dose will subsequently be adjusted, based on the outcome, for the second cohort.
Several experiments demonstrated the effect of PBI-1402 in mice that had their immune system suppressed by chemotherapy. The results clearly demonstrate that PBI-1402 promotes the growth of red blood cells, and also protects various tissues such as spleen and bone marrow from the toxic effects of chemotherapy.
“It is clear that the anemia associated with cancer or chemotherapy is an unsatisfied market and demonstrating PBI-1402 efficacy in such type of patients would represent a significant improvement to current therapy” said Pierre Laurin, chief executive officer of ProMetic. “Additionally, PBI-1402 has the potential to treat anemia not associated with cancer or chemotherapy. This would represent an expanded market made more accessible since, unlike EPO, PBI-1402 can be taken by the oral route.”