Panaxia Labs Israel Ltd, got positive topline results in its clinical trial evaluating bioavailability and safety of use of a variety of innovative delivery methods of medical cannabis products developed by the Panaxia Group. This is the first clinical trial of its kind to take place in Israel, to the best of the company’s knowledge, and one of the few performed in the world on medical cannabis-based products. An analysis of the results shows that the clinical trial successfully met its primary objectives.
The clinical trial commenced in January 2019 at the Wolfson Medical Center in Israel and included 12 healthy participants, according to a protocol approved by the Israel Ministry of Health (including the Medical Cannabis Unit) and by the Medical Center’s Ethics Committee (Helsinki Committee). It was a controlled, double-blind, multi-disciplinary trial involving single-day treatment of each of the innovative forms of the product, including sublingual tablets in varying doses; suppositories and extracts for inhalation using an inhaler; as well as Axiban®, sublingual cannabis oil manufactured by the company and marketed by Rafa laboratories ; Sativex®, the Gold Standard flagship product of the worldwide cannabis industry, and the only product containing THC from a plant source (cannabis), which was approved for sale by the European Medicines Agency (EMA); and a placebo. The clinical trial included a 12-hour follow-up period for each participant and each form of administration, with a set amount of time between each segment.
The primary objectives of the clinical trial were to evaluate the safety and bioavailability of the active substances in the blood of each form of administration, as well as the pharmacokinetic profile of each of the products. By examining the bioavailability of the products (the concentration of the substance in the patient’s blood, the rate of absorption in the bloodstream, and the fraction absorbed in the bloodstream of the total amount consumed), its pharmacokinetic efficacy was proven, and the main objective of the clinical trial was achieved. Moreover, regarding the products’ safety of use, no serious adverse events (SAE) were reported.
In light of the positive results that were achieved, the company intends to move forward with procedures in order to receive regulatory approval for the various formats of its products in Israel and in a number of European countries. Upon regulatory approvals, the company will commence marketing these products in Israel and exporting them to a number of European countries.
In addition to achieving the objectives set out in the trial’s protocol, the results analysis, comparing Panaxia’s products with the industry’s flagship Sativex products, indicate preliminary data suggesting that according to the company, its products have the potential for a significant breakthrough in comparison with Sativex (some comparison results to Sativex lacking statistical significance due to small number of participants, all other results show statistical significance ).
It was found that (1) Sublingual tablets produced by Panaxia have a faster rate of absorption into the bloodstream compared to Sativex; (2) Sublingual tablets produced by Panaxia have a lower variance in the rate of absorption into the bloodstream from patient to patient compared to Sativex; (3) Cannabis extracts for inhalation produced by Panaxia have a higher rate of absorption compared to Sativex, as well as a lower rate of metabolism in the liver (first pass effect); and (4) Following the administration of Axiban oil, the level of analytes found in participants’ plasma was similar to levels found after administration of Sativex.
In light of these preliminary data, the company is considering conducting a clinical trial to evaluate the efficacy and safety of Panaxia’s products in comparison with Sativex, and include a larger number of participants, in order to achieve statistical significance. The company will update if and when it decides to conduct an additional clinical trial.
“These clinical trial results are a significant achievement, demonstrating our R&D capabilities and positions Panaxia as one of the leaders in the industry worldwide,” says Dr. Dadi Segal, CEO of Panaxia. “As far as we know, Panaxia is the only Israeli medical cannabis company that has carried out such a comprehensive clinical trial to evaluate its products, and that has scientific proof of their bioavailability and safety. What is common and obvious in every existing drug in the pharma world, is nothing less than revolutionary in the Israeli cannabis industry, which didn’t start off in the pharma world, and as a result the efficacy of cannabis products was never tested. The significance of this is that once they are approved, these products will set a higher therapeutic standard, enabling both the patient and the physician to know for certain how much of the substance was absorbed into the bloodstream, the rate of absorption and the concentration in the blood. This critical information will allow patients and their physicians to feel much more comfortable and assured that the product they are using has been checked, and that its effects on our bodies are known.
Dr. Segal added: “Moreover, we are also thrilled about the preliminary data emerging from the results, which indicate better characteristics in comparison to the industry’s flagship drug. We intend to examine this data in a separate clinical trial, according to industry standards.”