ProMetic Life Sciences Inc. has received regulatory approval from Health Canada for the expansion of its lead compound PBI-1402's clinical programme to include the treatment of anaemic patients with Chronic Kidney Disease (CKD).
Nearly half of erythropoietin (EPO) sales in the US is used for anaemic patients with renal diseases and, as much as 60 per cent of EPO used in CKD patients is actually for 10 per cent-15 per cent of CKD patients requiring a high dose of EPO to treat their anaemia, a ProMetic press release stated.
The trial is designed to monitor the safety and tolerability of PBI-1402 and whether it has additive effects when combined with EPO in this high dose patient population.
"The mechanism of action of PBI-1402 is different from the current drug of choice for the treatment of anaemia, EPO," stated Dr. Christopher Penney, Chief Scientific Officer for the Therapeutic Unit of ProMetic. "PBI-1402 does not bind to the same cell surface receptor molecule as EPO, and therefore offers three potential uses for PBI-1402 to treat anaemic patients: as a stand alone treatment, in patients not responsive to EPO, and in combination with EPO."
"An additive effect on red blood cell progenitors in human bone marrow combining PBI-1402 and EPO in in-vitro cell culture has already been demonstrated" commented Dr. Lyne Gagnon, Director of Biology at ProMetic. "The prospect of improving the clinical outcome with the combination or even achieving a similar outcome with a lower dose of EPO would be a great benefit to this patient population."
This clinical trial will be undertaken at the Maisonneuve-Rosemont Hospital in Montreal, under the direction of Drs. Vincent Pichette and Martine Leblanc, Nephrologists. Patients enrolled in the study will be treated for a period of 12 weeks followed by 4-week observational period.
ProMetic Life Sciences Inc. is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand enabling technology. This technology is used in large-scale purification of biologics and the elimination of pathogens.