Kanabo has applied for approval to conduct a clinical trial using its proprietary cannabis inhalation formula with its VapePod device to determine its bioavailability and efficacy.
In accordance with ISO13485, Kanabo’s VapePod was produced in a certified GMP medical facility in full accordance with a formula that was developed and tested in Israel. This standard is often seen as the first step toward compliance with European regulatory requirements.
A Kanabo spokesperson told investors earlier this year the company had developed and launched the first medical cannabis vape formula in the United Kingdom that initially targets pain management.
A three-month trial, to be conducted by an Israeli-based company, will lead to an approval that could allow it to sell its VapePod device and formulations in the Israeli market, as the company previously announced in February 2021.
A cannabis vape cartridge approved by the Israeli government would become the first in the country, it said.
By providing physicians and medical establishments with evidence-based medicine, Kanabo said the three-month trial could also boost sales in the UK and Germany.
According to the company, this would be the first clinical trial for a cannabis vape pen in the world, thereby providing bioavailability and efficacy data.
As a result of its high bioavailability and rapid onset, the Company believes its VapePod provides cannabis-based treatments “more safely and simply than ever before.”
Since the end product contains 70% THC, it is pure enough to work in the handheld device, and doctors can administer the medication with precision micro-doses, it outlines.
It also allows researchers to collect accurate data to develop effective treatment regimens at the same time, thereby providing a more efficient means to deliver cannabis than smoking it.
The Hadassah Medical Centre has approved Kanabo’s clinical trial protocol for review by the Helsinki Committee, in partnership with Seach Medical Group.
During the trial, several cannabis formulas will be inhaled by healthy volunteers using the VapePod, which dispenses metered doses of standardised cannabis inhalation.
During its three-month trial, the Company plans to conduct a PK test to determine how the Company’s proprietary VapePod Formulas affect absorption, distribution, metabolism, and excretion (“ADME”), according to the company.
Using a clean and measurable method of treatment,’ Kanabo explained that the trial would target the growing segment of the medicinal cannabis market.
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.”
To address concerns regarding the licensing of e-cigarettes as medical devices in the UK, the MHRA, an executive agency within the Department of Health and Social Care, published updated guidance in October 2021. Doctors who want to quit smoking may be able to prescribe vaping devices with the new guidance if the devices prove effective.
Following a public consultation with the E-Cigarette Expert Working Group, a group of UK experts who provide oversight and advice to the MHRA, the updated guidance – under the heading ‘Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines’ – replaces the previous guidance.
Additionally, the MHRA provided further details on the licensing process for electronic cigarettes as medicines in its guidance. Moreover, a license would be issued only if the products met a set of quality, safety, and efficacy standards.
According to the agency, this may allow tobacco smokers who wish to quit or reduce smoking access to safe and effective products through prescription.
Since cartridges are the fastest-growing segment of the cannabis industry in North America, Tamir believes this category will also grow in the UK. He said that devices VapePod will help patients in the UK give up the habit of smoking medical cannabis flowers.
Kanabo disclosed last month that it had completed the majority of its due diligence for its proposed acquisition of Materia, a European-based medical cannabis and CBD company.
In addition to specializing in medical cannabis, Materia has subsidiaries in Malta, Germany, and the UK.
In order to expand and strengthen the supply value chain of medical cannabis and CBD products, Materia’s complementary infrastructure will be crucial.
Kanabo said it will gain direct entry into the German market, which generated revenue of over €200 million last year and is expected to remain a dominant player as the European market grows to a projected value of €3.2 billion by 2025, according to Prohibition Partners.
It has been reported by Reuters that Materia’s main focus to date has been the German market, with the company calling it “market number one, two, and three” in May 2021.
Kanabo and Provacan team up to create two new high-potency 72% CBD products for the UK market.
In partnership with Kanobo, Provacan, the science-led CBD brand from the market leader in cannabis research, brings the latest cannabis technology to the U.K. with two ultra-potent 72% CBD formulas in it’s award-winning VapePod range.