[source: Kanabo]
Kanabo Group (KNB ) has applied to undertake a bioavailability and efficacy trial of its proprietary Cannabis inhalation formulas used in conjunction with its VapePod device.
Kanabo’s VapePod, which is based on a formula developed and tested in Israel, has been produced in a certified GMP medical facility in full compliance with ISO13485, a standard that is often seen as the first step in achieving compliance with European regulatory requirements.
Earlier this year, Kanabo told investors that it had developed and launched the first medical cannabis vape formula in the United Kingdom aimed at initially targeting pain management.
The Israeli-based medicinal cannabis company, which made its debut on London’s main market in February 2021, outlined that one of the outcomes of this three month trial will be an approval that would enable it to sell its VapePod device and formulas in the Israeli market.
If approved, this would be the first cannabis vape cartridges in the Israeli market, it explained.
Kanabo said the three month trial would also support sales in both the UK and Germany by providing physicians and the medical establishments with evidence-based medicine.
The Company also noted that the trial is expected to be the first clinical trial for a cannabis vape pen in the world and that it would therefore provide bioavailability and efficacy data.
The Company believes that by providing high bioavailability and exhibiting rapid onset, its VapePod can deliver cannabis-based treatments “more safely and simply than ever before.”
At 70% THC, the purity of the end product makes it amenable to use in the handheld device, which also allows doctors to administer the medication via precision micro-dose, it outlines.
In doing so, the company said VapePod can provide a more effective method of delivery than compared with smoked cannabis, ‘without the health implications, and allows accurate data to be collected by researchers developing effective treatment regimens at the same time.’
Kanabo, in partnership with Seach Medical Group, has submitted a clinical trial protocol for approval at the Hadassah Medical Centre and subsequent review by the Helsinki Committee.
The trial will test the impact from the inhalation of various Cannabis formulas via its the VapePod, which dispenses standardised and metered inhalations, on healthy volunteers.
As part of the three month trial, participants will undertake a pharmacokinetic (“PK”) analysis to define THC and CBD Absorption, Distribution, Metabolism and Excretion (“ADME”) following the administration of the Company’s proprietary VapePod Formulas, it outlined.
Kanabo said the trial will target the growing segments of the medicinal cannabis market for patients who want to manage their pain using ‘a clean and measurable method of treatment.’
Commenting, Avihu Tamir, Kanabo’s CEO said: “This is a ground-breaking trial which will evaluate the bioavailability and efficacy of Cannabis-based inhalation formulas administered via Kanabo’s VapePod medical device. It is an important milestone as it will help us with our ongoing efforts to allow specialist consultants to prescribe a metered dose of medicinal cannabis that is healthier for patients than the alternative which is typically smoking.”
In October 2021, the MHRA, the executive agency of the Department of Health and Social Care in the UK, published updated guidance on the steps required to licence an e-cigarette as a medicinal product in the UK. The new guidance is expected to pave the way for doctors to prescribe vaping devices to people who want to quit smoking - that is if it proves effective.
The updated guidance - under ‘Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines’ - followed a consultation with the E-Cigarette Expert Working Group, a group of UK experts who provide oversight and advice to the MHRA.
Within its guidance, the MHRA also provided further details on the steps required to licence an e-cigarette as a medicinal product. It outlined that to achieve a licence, products would need to ‘meet the standards of quality, safety, and efficacy expected of medicinal products.’
If successful, this would potentially allow safe and effective products to be made available for prescription, for tobacco smokers who wish to quit or reduce smoking, the agency outlined.
Since cartridges are the fastest-growing segment of the cannabis industry in North America, Tamir expects this category to be “significant in the UK.” He said devices VapePod will enable patients in the UK “to move away from the harmful habit of smoking medical cannabis flowers.
Last month, Kanabo told investors that it had finished the majority of its due diligence work as part of its proposed acquisition Materia, a European-focused medical cannabis and CBD firm.
Materia is an independent processor and distributor of medical cannabis and CBD wellness products focusing on the European market, with subsidiaries in Malta, Germany and the UK.
The Board believes that Materia’s complementary infrastructure will be crucial to expanding and strengthening its existing supply value chain of medical cannabis and CBD products.
Kanabo said it will acquire direct entry into the German market, which was valued at over €200m last year, and is anticipated to remain the dominant market as the European market grows to a forecasted total size of €3.2 billion by 2025, according to Prohibition Partners.
According to reports from Reuters, Materia’s main focus to date has been on the German market, with Executives calling it “market number one, two and three” back in May 2021.
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