Neurotech International Ltd (ASX:NTI) has today confirmed the successful completion of in-vitro studies using human brain cells to assess and validate the anti-inflammatory and neuro-modulatory properties of its proprietary DOLCE/NTI cannabis leads.
In vitro studies are those done in the laboratory within the confines of a test tube or laboratory dish. Neurotech’s in vitro studies have shown the superiority of the DOLCE/NTI strains over CBD alone and now pave the way for future studies, including phase 1 clinical trials.
Neurotech has been undertaking a series of in-vitro studies to assess the neuroprotective, anti-inflammatory and neuro-modulatory activities of the proprietary DOLCE/NTI cannabis leads CBDA, CBDP, CBDB.
The DOLCE/NTI strains are unique in that they contain minimal THC (<0.3%), which may result in a less onerous regulatory pathway to commercialisation (any cannabis strain with a THC level above 0.3% is regulated as a narcotic).
The in-vitro studies were conducted at three leading independent laboratories – Monash University, University of Wollongong and RMIT University.
Neurotech previously reported the mode of action and powerful neuro-protective and modulatory properties of these unique strains versus CBD alone. These in vitro findings have been further validated in these final trials.
As many as one billion people suffer from a neurological disorder
DOLCE/NTI strains have shown to significantly improve neuronal cell health, cell viability and have the potent ability to reduce inflammation compared with CBD alone.
All these physiological processes are vital in managing disorders with unmet need for therapies including; Autism, Epilepsy, ADHD, Alzheimer’s disease and related neurological disorders.
The World Health Organisation estimated that in 2006, as many as ‘one billion people’ suffered from a neurological disorder. Without effective treatments or cures, the number of those affected by neurological disorders will continue to increase as the world’s population grows.
With a range of disorders impacting so many people, the market opportunity for Neurotech is large. The global market size is estimated to be $112BN per year by 2027, growing at a rate of 5% per annum.
Path cleared for Phase 1 clinical trials
Neurotech’s in vitro studies have shown the superiority of the DOLCE/NTI strains over CBD alone and now pave the way for future studies, including phase 1 clinical trials.
Phase 1 clinical study preparations are currently underway to develop the optimum delivery and dosage forms.
Commencement of stage 1 is expected in Q1/ 2021. Clinical trials will be conducted under the guidance and supervision of A/Professor Michael Fahey (Head of Paediatric Neurology, Monash Children’s Hospital).
A/Professor Fahey recently completed his prestigious Fulbright scholarship in the USA and has extensive experience in the clinical development and management of medicinal cannabis in children with autism and related neurological disorders.
A/Prof Fahey and his team are experts in neurodevelopment and neuroprotection studies across various patient groups. “Preclinical studies suggest that these strains exhibit potent and unique properties when compared to CBD alone and warrant the further assessment of these strains in phase 1 clinical trials,” said A/Prof Fahey.
“These final trial results are very encouraging, in particular, the powerful anti-inflammatory mode of action of our strains compared to CBD alone,” said Brian Leedman, Chairman of Neurotech. These results demonstrate that the DOLCE/NTI leads may have a broader application in relation to the management and treatment of a number of neurological disorders”.
Neurotech continues to progress the development of its propriety cannabis strains, and is setting itself up for an active first half in 2021.