Canadian Manufacturing

Providence Therapeutics announces first subject has been dosed in COVID-19 vaccine trial

mRNA vaccine maker has begun first human trial of a fully made-in-Canada vaccine.

January 26, 2021  by CM Staff

TORONTO and CALGARY — Providence Therapeutics has announced on Jan. 26 that it has begun dosing volunteers in human clinical trials of its COVID-19 vaccine. PTX-COVID19-B is a messenger RNA (mRNA) vaccine and is the first fully made-in Canada COVID vaccine to reach this stage of development.

Subjects will be monitored for a total of 13 months from the beginning of the trial. However, there will be enough data accumulated by April 2021 to move into Phase 2 in May 2021, pending regulatory approval.

The clinical study of PTX-COVID19-B will be carried out in Toronto, ON. Sixty volunteers between the ages of 18-65 will be enrolled in the Phase 1 study and divided into three groups of 20. Three different dose levels of PTX-COVID19-B will be administered together with a placebo in each group.

The study will test the immunogenicity of the vaccine, as well as its safety for human use. Pending positive results, commercialization is estimated to begin end of 2021 or early 2022.

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“We are thrilled to begin human clinical trials of PTX-COVID19-B. Having a made-in-Canada solution to address the global COVID-19 pandemic will augment the reliability of vaccine supply for Canadians, contribute to the global vaccine supply and position a Canadian company on the global stage as a contributor to the solution,” says Brad Sorenson, CEO of Providence Therapeutics. “We would also like to extend our gratitude to the volunteers who have stepped forward to take part in this important clinical trial.”