September 10, 2019
Building Momentum Toward First-in-Human Clinical Trials
Morphocell Technologies Inc. held a successful pre-pre-Clinical Trial Application (CTA) meeting with Health Canada in August 2019.
Health Canada agreed in principle to the proposed non-clinical plan in support of a first in human clinical trial. The discussion focused on the acceptability of our non-clinical and quality development plans for ReLiver®ELT. A high-level discussion on the potential design of our first-in-human clinical trial that provided great direction for fine-tuning our approach.
Health Canada’s Biologics and Genetic Therapies Directorate and Medical Devices Bureau offered valuable guidance on data that would be considered acceptable to support our initial CTA.
The Morphocell team is looking forward to using Health Canada’s input to further refine ReLiver®ELT development plans. More to come – follow us on Twitter for updates.