ProMetic Life Sciences Inc met US Food and Drug Administration's (FDA) Division of Medical Imaging and Haematology Products to discuss the regulatory pathway for the development of PBI-1402.

“We are very excited by the outcome of this meeting" indicated Pierre Laurin, ProMetic's president and chief executive officer. "The Division of Medical Imaging and Haematology Products acknowledged that PBI-1402 is a novel, first-in-class drug that differs, via its mechanism of action, from existing medications approved for the treatment of anaemia, such as the marketed erythropoiesis-stimulating agents (ESAs). This represents the achievement of a key milestone for our partnering discussions and strategic decisions as it creates a clear path for PBI-1402 and analogues to address unmet medical needs,” Laurin added.

The guidance and recommendations provided by the US FDA, corroborates ProMetic’s strategy for the global development of PBI-1402 and its analogues for the treatment of anaemia in cancer patients and in patients with chronic kidney disease.

The US FDA sought recommendations from the Oncologic Drugs Advisory Committee in March 2008 based on increased evidence of ESAs’ effect on patient survival, tumour progression and thrombotic events. Consequently, in December 2008, the US FDA published a Medication Guide for ESAs warning that serious adverse events, including death, were more likely to occur if patients undergoing treatment with ESAs had cancer. Additionally the risk of these serious adverse events occurring would be greater if the haemoglobin target was > 12 g/dL.

ProMetic scientists have demonstrated that PBI-1402 differs from ESAs by virtue of a unique mechanism of action. Several studies to date indicate that PBI-1402 reduces tumor growth and does not elevate haemoglobin to potentially dangerous levels.

ProMetic Life Sciences is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand technology.