This Alberta scientist received worldwide attention for his cannabis and COVID-19 study.
Submitted by Marijuana News
But getting funding and a clinical trial going in Canada remains a massive challenge
Dr. Igor Kovalchuk, a biological scientist and professor at the University of Lethbridge, wasn’t expecting his phone to ring this much.
In April, he and a team of researchers and biologists published preclinical research in PrePrints, a multidisciplinary publishing platform, that demonstrated certain cultivars (strains of cannabis) may reduce the rate of entry of COVID-19 into human cells.
But despite the worldwide interest the research garnered, Kovalchuk says it has been difficult to move the study forward in Canada, where a lack of funding and limited interest from the federal government, on top of working through a global pandemic, has created a challenging environment.
The decision to publish with PrePrints in April was a calculated one. It allowed Kovalchuk’s team to get the research out immediately, without the delay of being peer-reviewed. The strategy worked. The media picked up on the research shortly after it was published. The study, which is currently being peer-reviewed for publication in a scientific journal, has made waves globally.
How did it happen?
The team worked with 3D models of oral, airway and intestinal tissues and tested about 400 different strains using botanical extracts. They found that certain high CBD strains were effective in modulating the ACE2 gene expression and ACE2 protein levels, believed to be the gateway for COVID-19, potentially inhibiting the virus’ entry into cells.
Kovalchuk, who is licensed by Health Canada to conduct cannabis research, says that certain cultivars may be useful as a form of adjunct therapy in the treatment of COVID-19. He described the possibility of creating an infused mouthwash, for example, as a preventative measure.
Conducting research with his wife Olga, Kovalchuk has worked in various areas of plant biotechnology and genetic engineering for the past two decades. He’s never had a response quite like this to his work before.
When he takes a call from The GrowthOp, he says it is his 30th interview in the last five days. “For us to have an impact in terms of moving towards a clinical trial, we needed publicity,” he says. “We know we normally don’t do this. We are successful scientists with a high rate of publications. The only reason why we’ve done it is to get interest from potential partners to do the clinical trial.”
Last week, the research team published a second study relating to the use of cannabis extracts to reduce the cytokine storm that has been linked to severe cases of coronavirus and found that again, certain high CBD strains were beneficial. (All the strains tested were lab-created hybrids and are not yet commercially available.)
Investors in distress
Even with his scientific background and his connections in the cannabis industry — Kovalchuk is the CEO of Pathway Rx, a medical cannabis research company — the professor says it has been difficult to find a Canadian partner to move the research forward.
Conducting the clinical trial could cost anywhere from $200,000 to $500,000, he estimates. Money that is not easy to come by right now. “A lot of (investors) are in distress and Canada is not alone in this respect. And therefore, that’s the last thing on their agenda. And in the U.S. it’s also quite difficult to register for such a trial for multiple reasons, even getting material from here to the U.S. to study is such a huge burden.”
Despite that obstacle, Kovalchuk says they are currently engaged in discussions with a potential U.S. partner. “Frankly right now, we do not have any Canadian partners that are interested in moving it towards clinical trials. That means that there will be no clinical trial in Canada until this happens.”
And while Canada is happy to be recognized as a world leader in cannabis and cannabis research, to date, Health Canada has not authorized any clinical trials intended to study cannabis in the context of COVID-19.
Safety must be proven
There’s also another potential obstacle to Kovalchuk’s study getting off the ground.
A spokesperson for Health Canada told The GrowthOp that “before any drug moves to a clinical trial stage, there needs to be sufficient safety data available to determine that potential benefits of the treatment are expected to outweigh its potential risks.”
In an emailed statement, they continued, “Existing information on CBD would provide information on the general safety profile of the CBD drug product. However, safety information specific to the formulation being studied would also be required.”
And herein lies a problem: It is not yet clear which cannabis compounds are demonstrating effectiveness against the virus. It’s likely not CBD alone, as some high CBD cultivars performed poorly, even increasing the expression of ACE2.
While there is enough research out there to demonstrate that CBD and THC are safe, other parts of the plant, including terpenes and flavonoids, are understudied. Any potential formulations that involve these compounds, have to first demonstrate that they are safe before they can reach the clinical trial stage of research. Kovalchuk says this is a roadblock that can push research back years.
“We did not talk about active ingredients. It would be difficult to pinpoint what is the perfect cocktail because we’re dealing with botanical extracts. Frankly, for us, it’s irrelevant what the active ingredient is. If we know that a specific extract works, does it matter? For science, yes; for a patient who is infected, likely not.”
To potentially register for a clinical trial, Kovalchuk says he can list the cannabinoids where data for safety exists and hope that is enough to move it forward.
“The thing is, if you want to make it to medicine, that would be the first question from Health Canada, and the FDA (U.S. Food and Drug Administration) and when I submit the clinical trial application, I have to hypothesize what the active ingredient is and actually state it in the application. So, I can list a bunch of cannabinoids where the data for safety exists.”
The information is out there
There is some envy in Kovalchuk’s voice when he speaks of researchers in Israel, which is widely recognized as the world’s leading country when it comes to cannabis research. Currently, there are three clinical trials underway in Israel that relate to CBD and COVID-19. “In Israel, all these clinical trials are much easier to register,” Kovalchuk explains. “They go through an expedited process. All clinical trials, typically with cannabis, are approved without additional vigorous safety data because the information is out there.”
Despite the regulatory hurdles, Kovalchuk says Canada is in a better position than most countries when it comes to studying cannabis. He’s quick to point out that he and his team have benefited from research grants from the federal government.
And he remains hopeful that his team will find a partner and reach the clinical trial stage. “I believe we will be able to. My take on this is that an infection of this magnitude is going to be seasonal. Therefore, if a drug with cannabis is over the counter that would help immensely to give people a better chance, either to prevent infection or to cope with a milder disease rather than a more severe one.
“So no doubt it’s going to happen. It just needs more time, needs more partners, and needs more interest from the government.”
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