Clinical Development Path of Buccal and Oral Products
Perth, Feb 6, 2015 AEST (ABN Newswire) - Phytotech Medical Limited (
ASX:PYL), the Australian owned Medical Grade Cannabis (MGC) company and the first MGC company to list on the Australian Stock Exchange, is pleased to provide an update on the research and development of its MGC based therapeutic delivery systems for administering Medical Grade Cannabis (MGC).
Highlights:
- Phytotech Medical is developing an oral capsule and buccal patch therapeutic products containing a combination of Cannabinoid (CBD) and Tetrahydrocannabinol (THC) for treating various clinical indications
Favorable regulatory path due to;
- Both the THC and CBD compounds are currently used in commercially registered products and as such are proven to be safe and efficacious
- The buccal and oral products in development with Yissum are based on proprietary technologies already implemented in commercial products, significantly lowering the regulatory hurdles
The clinical-development regulatory route for both the oral capsule, which demonstrated in pre-clinical studies enhanced bioavailability of THC or CBD and the buccal muco-adhesive patch is expected to be shorter and simpler to register, when compared to a new drug entity.
Both cannabinoids to be used in the products; Cannabinoid (CBD) and Tetrahydrocannabinol (THC), are currently used in commercially registered products and have been prescribed to patients for an extensive period of time. As such both have been proven to be safe and efficacious.
The products in development are based on Yissum's proprietary technologies, implemented in various commercial products.
Using active ingredients, which are already registered and implemented in technologies is expected to markedly decrease the regulatory requirements resulting in a significantly shorter and less expensive pathway.
Managing Director of Phytotech Boaz Wachtel commented: "Our agreement with Yissum enables us to harness existing technologies and cannabinoids, which have previously been commercialised, thereby decreasing the development period. Whilst there is never zero risk in biotech development and unexpected delays can occur in clinical trials we are expecting that the clinical development path for the products currently in progress will be significantly shorter than the market average."
Under the agreement with Yissum, Phytotech is utilizing Yissum's state-of-the-art technologies to develop an oral capsule and buccal patch containing a combination Tetrahydrocannabinol (THC) and Cannabinoid (CBD) for treating a variety of clinical indications.
The technology, which will be able to overcome the effects of first pass metabolism will markedly increase the oral absorbance of the active cannabinoid and in pre-clinical studies, the formulations of CBD and THC for use in the oral capsule showed significantly enhanced bioavailability.
About MMJ Group Holdings Ltd
MMJ Group Holdings Ltd (ASX:MMJ) is a global cannabis investment company. MMJ owns a portfolio of minority investments and aims to invest across the full range of emerging cannabis-related sectors including healthcare, technology, infrastructure, logistics, processing, cultivation, equipment and retail. For MMJ's latest investor presentation and news, please visit: https://www.mmjphytotech.com.au/investors/
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