Cannabis for COVID-19 medical trial starts in Israel

Cannabis news is high on our radar for coronavirus, as Israel is a medical cannabis pioneer dating back to the 60s thanks to Prof. Raphael Mechoulam. The Tel Aviv hospital Ichilov has already gone ahead started using CBD or the non-psychotropic parts of the cannabis plant against the novel coronavirus in a new study. And now we are told of a second study using CBD by a company called Stero – developing CBD into a novel therapy.

All cannabis plants have CBD and THC molecules in them, and about one hundred or more other active ingredients. Some parts of the natural plant can be isolated or simply synthesized for therapeutic effects. And this is how drug developers hope to make new inventions and make money.

The second study on COVID-19 is now being initiated by Stero Biotechs, an Israel-based, clinical-stage company focused on Cannabidiol (CBD) formulation research and development, in a collaboration with its main partner and shareholder, Mor Research Applications, the commercial arm of Israel’s largest health provider, Clalit.

Steros applies CBD and makes CBD products to help calm down lung and tissue inflammation in corona patients, reducing the use of and improving the efficacy of steroids. Steroids are critical for reducing inflammation in hospitals. I saw how they helped my dad when he was fighting cancer pain. Steroids are used to reduce inflammation. They reduce pain and make pain meds work better.

But extended use of steroids creates serious side-effects, like fragile bones or osteoporosis. One day my dad stood up and his femur just crumbled. His bones were disintegrating. If Steros gets fast-tracked for CBD use in inflammation in hospitals for corona specifically and later for cancer, that’s a silver lining.

Medical cannabis in Israel

Touted as a wonder drug by the medical cannabis industry, even though the well-funded medical cannabis company Syqe is starting to lay off employees, we will start to see more cannabis in hospitals as physicians scramble to assess how to treat COVID-19 with tools they have on hand. Cannabis is one of them.

Largely approved for medical use in the general population in Israel (it is not exactly easy to get a permit though), cannabis is widely accepted, if only quietly in the establishment. It is known that pain doctors treating cancer patients in Israel prescribe it. Or at least whisper to patients on how to find it.

The problem is that few doctors if any at all know how to prescribe medical cannabis correctly (take 3 gummies and call me in the morning?) and this is why we need novel drug companies who can understand dosing and therapeutic methods.

That’s what Stero aims to do. Their unique application is to enhance the effects of steroids, widely used to reduce inflammation of all kinds. There is a limit to how long steroids can be taken, as long term steroids are very destructive to the body. Physicians would like to use them less. Stero might have the way, using CBD.

Stero’s new 10-patient study, which is starting now will be a small-scale clinical trial taking place at the Rabin Medical Center in a Tel Aviv suburb called Petach Tikva. Pending final approval by the final Helsinki Committee the study will be a PoC or proof of concept study, a study that happens before wider clinical trials are initiated. PoC studies are the first step between a go and no go in a clinical study.

In the PoC Stero Biotechs aims to benefit and help hospitalized patients with COVID-19 infection. The treatment cycle will be for a few weeks with a subsequent follow-up period of the same length, the company reports.

“We estimate that our CBD-based treatment can enhance the current treatment of those patients who are in life-threatening conditions,” says David Bassa, the CEO of Stero Biotechs.

“Hospitalized COVID-19 patients are mostly being treated with steroids and our study is planned to demonstrate the benefit of a combined solution with Steroid treatments. We are hopeful that this study will lead to faster benefit for the growing number of COVID-19 patients in Israel and around the world.”

After the initial PoC, Stero plans to scale up and expand to a Phase IIa multi-center clinical trial, with an additional 40 hospitalized patients with COVID-19 Infections, under the usual US-governed FDA clinical trial guidelines and regulations. The FDA is based in Maryland and Israel has been working with the US in clinical trials for decades.

Stero was founded in 2017 to enhance the effects of steroid treatments. The company reports having a wide patent on CBD applications, covering over 130 autoimmune and inflammatory diseases by name, CBD from any source (synthetic or botanic), CBD in any combination, CBD in any dosage and in any delivery system.

Steroid treatment is usually the first or second line of treatment for hospitalized patients. CBD enhances the therapeutic effect of steroid treatment and treats the bio-mechanism affected by the virus.

The initial study will evaluate the tolerability, safety, and efficacy of the CBD treatment, for hospitalized patients with COVID-19 Infections.

While you could theoretically plants some high CBD cannabis strains in your garden and self-medicate, you may or may not know how to dose or take the treatment. For that you would need to ask an expert, still very hard to find in the science of cannabis as medicine. That’s why novel drug companies developing solutions get my support.

If you are interested in the first study on coronavirus and cannabis we reported on, you can find it here.

In other medical news from Israel, Israel’s Pluristem using stem cell treatments, seems to bring patients back to life.