The company plans to study the safety and efficacy of PBI-1402 in up to 30 cancer patients undergoing chemotherapy and suffering from anemia.
This clinical trial will be undertaken at Maisonneuve-Rosemont Hospital, in Montreal, under the supervision of Drs Denis-Claude Roy (hematologist) and Julie Beaudet (oncologist). “Following the results obtained during the phase I trial, displaying an excellent safety profile and an increase of reticulocyte numbers, we are very excited to initiate this phase Ib/II study in chemotherapy-treated patients”, said Dr Denis-Claude Roy.
In addition, ProMetic scientists have made significant progress towards the elucidation of the mechanism of action of PBI-1402. This important step will support future clinical development strategies for this candidate drug.
The mechanism of action of PBI-1402 is different from the current drug of choice for the treatment of anemia, erythropoietin (EPO). As such, PBI-1402 offers the potential to treat anemic patients who are not responsive to EPO.
Furthermore, since PBI-1402 has shown an additive effect in combination with EPO on human progenitor cell proliferation in vitro, it could be used in monotherapy and/or in combination with EPO.