Impression Healthcare Limited ('Impression', 'IHL' or the 'Company') is pleased to announce that it has successfully registered its first clinical trial to investigate the effects of its formulations of toothpaste and mouthwash containing Cannabidiol ('CBD') on Gingivitis and Periodontitis, otherwise known as Gum Disease or Periodontal Disease.
The completed trial protocol has been submitted to and registered on the Australian and New Zealand Clinical Trials Registry ('ANZCTR'). IHL will now formalise approval for the trial from the Human Research Ethics Committee ('HREC'), and other approvals as necessary, prior to patient recruitment and dosing; with updates to the ASX at key junctures. Patient recruitment is expected to commence in August.
Importantly, the trial is considered a phase 2a randomised controlled clinical trial designed to investigate clinical efficacy and safety and is a more significant trial than first considered and announced to the ASX on 21st of March 2019, when the Company formalised activities with Cannvalate.
The trial will include 40 participants using the toothpaste and mouthwash three times daily over a period of 30 days. Gum inflammation will initially be induced within the cohort and then monitored. Overall gum health will be measured using the gingivitis bleeding index after 5 days of treatment and then again after 30 days. Safety of the products will be measured by the number and type of adverse events reported by trial participants.
The cannabinoid formulation for the clinical trial is being manufactured to Good Manufacturing Practice (GMP) standards by AXIM Biotechnologies Inc, pursuant to the supply agreement announced on 3rd of June 2019.
Impression Healthcare CEO, Mr Joel Latham said; "Formal registration of the gingivitis and periodontitis trial represents significant progress in IHL's medicinal cannabis activities and is the culmination of many months of work by our team and research partners.
We are excited to have assembled highly qualified researchers for a world first trial for the use of CBD in treatment of Gingivitis and Gum Disease, which are major problems representing a major market.
We are confident that the quality of the trial will supply the requisite peer-reviewed data for unique product sales under the SAS and will further develop commercialisation opportunities for our products in this field".
– Impression Healthcare CEO, Mr Joel Latham
About Impression Healthcare Limited (ASX: IHL)
Impression Healthcare Limited is an innovative healthcare company that sells customised oral devices both direct-to-the-consumer and via the Company's growing B2B preferred practitioner network of dentists. With its own laboratory in Victoria, Australia, Impression offers best-in-class teeth-protection and helps its customers to combat bruxism, snoring, mild-to-moderate sleep apnoea and teeth discolouration with custom-fitted oral devices.
Impression has broadened its commitment to disruption in the healthcare sector by progressing multiple opportunities in the field of medicinal cannabis. IHL has its licenses in place to import, export and distribute cannabis products. In March of 2019, Impression executed a binding collaboration with Cannvalate and Swinburne University of Technology to undertake four medicinal cannabis clinical trials. Cannvalate is Australia's largest distributor of medicinal cannabis products.
IHL also has a collaboration agreement with leading US Cannabinoid therapeutics Company, AXIM Biotechnologies Incorporated; a license agreement with Resolution Chemicals for the production and distribution of Dronabinol in the USA, Canada, Australia and New Zealand; and also intends to distribute medicinal cannabis oils through the Cannvalate network of cannabis medicine prescribers throughout Australia.
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