Providence Therapeutics announced on Jan. 26, that it has begun human clinical trials of a COVID-19 vaccine.
“We started working on the vaccine when COVID-19 hit in March, and by the middle of April they had it formulated and ready,” said the Chief Medical Officer at Providence Therapeutics, Dr. Piyush Patel.
Volunteers between the ages of 18 to 65 will be given two doses of the PTX-COVID19-B RNA (mRNA) vaccine, 28 days apart, and then monitored for 13 months.
The volunteers that are enrolled in phase one will be divided into three groups of 20, and given three different dose levels, with a placebo in each group.
Enough data is expected to be accumulated by April, to move into phase two in May, pending regulatory approval.
“We’re hoping to see the results by the end of April. We’re following the patients for a year to make sure they continue to do well,” Patel said.
Adding, “Early next year is when we’re hoping to get it to market if things go well for us.”
Preclinical studies of PTX-COVID19-B supported robust antibody responses against the spike (S) protein of COVID-19 that were highly effective at neutralizing the virus in multiple assays.
“It’s similar to the Pfizer and Moderna vaccine, it’s completely synthetic, there are no biological things in it at all. Essentially, we took amino acids, and we put them in a vial, we added lipids and enzymes to construct the RNA. It’s a complicated process,” Patel said.
“It’s made in-Canada, it’s very similar to the other two vaccines that are currently being administered in Canada. The safety is very good of this vaccine, and it’s very effective. We expect it to be the same level as the other vaccines, around 90 to 98 per cent accuracy,” he said.
The vaccine will cause people to develop antibodies to neutralize the COVID-19 virus when exposed.
“It’s a fake infection to the body, the body makes antibodies, then in the future if an individual gets the virus, the body has seen the virus and destroys in immediately,” Patel said.
Developing a made in Canada COVID-19 vaccine was extremely important, as supply levels decrease.
“Essentially, we are at the mercy of other governments, who can very easily make a decision to look after their citizens before they look after Canadians,” Patel said.
“It’s very important to have a domestic supply, we really should have had a domestic supply all along in Canada. This is our chance to have a Canadian based supplier and manufacturer who have served the market, so we are not at the mercy of foreign governments,” he said.
Providence Therapeutics has relied on the contributions of collaborators to reach this phase of vaccine development, including the Government of Canada through the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) program, and the laboratories of Dr. Mario Ostrowski, Dr. Anne-Claude Gingras, Dr. Samira Mubareka, Dr. Rob Kozak, and Dr. Michael Pollanen.
“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,” said CEO of Providence Therapeutics, Brad Sorenson.
Adding, “We would also like to extend our gratitude to the volunteers who have stepped forward to take part in this important clinical trial.”
For more information, please visit https://www.providencetherapeutics.com/.
