Providence Therapeutics has announced that Health Canada has provided a Notice of Authorization for its Clinical Trial Application.
This enables the Canadian biotech business to start human clinical trials of its COVID-19 vaccine. PTX-COVID19-B is a messenger RNA (mRNA) vaccine and can be the very first completely made-in-Canada COVID vaccine to accomplish this stage of growth.
Health Canada’s authorization implies Phase I clinical trials will start early in the New Year. Afterwards phase clinical trials are expected to move in 2021, subject to regulatory acceptance.
This wouldn’t have been possible without two dozen exceptionally committed Providence workers which have been working long hours under considerable pressure.
Furthermore, It’s important that the Vital gifts of the collaborators are well known:
PTX-COVID19-B incorporates industry-leading lipid nanoparticle technology licensed by an affiliate of Genevant Sciences Corporation (Vancouver, BC), and the dedicated professionals at Genevant led to this vaccine development with invaluable technical and production assistance.
“We advised Health Canada empowerment and are eager to start clinical trials. This implies we could continue our crucial work of creating a made-in-Canada remedy to cover the worldwide COVID-19 pandemic.
“There’s a great deal of work that lies ahead, but the statement is equally essential as a Canadian firm will be set to help bring about the solution, strengthen domestic safety of supply to Canadians, and increase the international supply to satisfy overwhelming worldwide requirement for safe and effective vaccines,” Sorenson added.
“The vaccine growth thus far has efficiently validated mRNA for a vaccine system. Providence has been operating with mRNA for many decades. We plan to finish the trials, also concurrently secure manufacturing capability to produce vaccines here in Canada,” added Dr. Jared Davis, President of Providence Therapeutics.
Preclinical studies encouraging strong immunogenicity of PTX-COVID19-B were completed in the Combined Containment Level 3 Center at the University of Toronto. The results revealed strong antibody responses against the spike (S) protein which were highly capable of preventing the virus in many assays.
Around Providence Therapeutics
Providence Therapeutics is Canada’s top mRNA vaccine firm. In reaction to a global demand to get a COVID-19 vaccine, Providence has enlarged its focus beyond oncology and committed its power and resources to come up with a world-class mRNA vaccine for COVID-19. Providence Therapeutics is focused on serving the needs of Canada, along with other nations which could be underserved by big pharmaceutical applications. To learn more, please see ProvidenceTherapeutics.com.
