Neurotech to commence clinical study program this quarter
Neurotech International Limited (ASX:NTI) has provided an update on its clinical study program.
As we reported in late December, Neurotech successfully completed a series of in vitro studies that demonstrated that the NTI/Dolce strains, with the newly discovered rarer cannabinoids CBDP and CBDB, have powerful and unique anti-inflammatory and neuro-modulatory properties.
The neuro-modulatory activity of CBD has been well characterised and documented over the last five years.
Recent studies and discoveries have confirmed that the rarer cannabinoids (CBDP and CBDB) have wider - novel neuro-modulatory and neuro-protective modes of action when compared to CBD alone.
An exciting new chapter into the field of medical cannabis is being opened up by the discovery and research of new cannabinoids, potentially offering a wider range therapeutic options to patients.
Following the successful in vitro findings, Neurotech has begun designing a phase I/II study to assess the safety and efficacy of the novel NTI/Dolce strain in a paediatric population.
Under the guidance of A/Professor Michael Fahey, the company has been engaging with international clinical experts in the field of translational medicinal cannabis to also assess the efficacy of the Mente device when used in combination with the novel NTI/Dolce medicinal cannabis strains.
If successful, this combination of the cannabis strains and the Mente device has the potential to be a “world-first” in the management of neurological diseases.
Neurotech is on-track to initiate its phase I/II clinical program through Monash Children’s Hospital toward the end of this current quarter.
Commenting on the commencement of the forthcoming clinical study, Brian Leedman, Chairman of Neurotech International said, “It is exciting to be able to conduct these first-in-human studies at Monash Children’s Hospital to assess the safety and efficacy of our cannabis strains in children with autism.”
“Positive results will pave the way for larger studies to address the unmet need for effective treatments in broader neurological conditions”.
Neurotech’s paediatric focus
Working together with RMIT and the Victorian College of Pharmacy, Neurotech is in the process of developing a child friendly delivery form for its NTI/Dolce cannabis strains.
This study is intended to form the basis for larger future studies which will assess the efficacy of these strains in a broader patient population in respect of autism and other neurological disorders.
Prototypes are being developed which will be used in the upcoming clinical program, and all regulatory documentation for program initiation is currently underway in line with TGA and hospital ethics requirements.
Journey to TGA approval
Along with this, Neurotech has been working with national and international regulatory experts to map out its preferred path forward regarding product development and registration for Australia and globally.
The recent TGA developments regarding the ‘over the counter’ sale of CBD products are promising for the company, who see these clinical studies as one important step toward any approval to sell CBD products.
The study will be the first to assess the safety and efficacy of the newly discovered rarer cannabinoids CBDP and CBDB with regards to neurological disorders.
The NTI/Dolce full spectrum plants have demonstrated through in vitro to have very powerful properties in relation to suppressing and inhibiting inflammation in neuronal and microglial cells derived from the human brain.
The strain has also demonstrated an “entourage effect”, a mechanism where the various phytocompounds (“phyto” means plant) found in cannabis such as cannabinoids cooperate to attain a compounded effect – one that is greater than the sum of its parts
NTI/Dolce full spectrum plants exhibited properties that are far more powerful and novel when compared to CBD alone.
CBD products are currently the market leaders and considered to be the ‘gold standard’ in the medicinal cannabis field.
When compared in pre-clinical studies to Aricept and CBD alone, the Dolce/NTI strains demonstrated 30% and 80% more potency respectively.
Aricept is the leading therapy in the early treatment of Alzheimer’s Disease and currently has annual sales of over $1 billion USD.
These studies demonstrated that the DOLCE/NTI full spectrum strains:
- Reduced inflammation within the brain cells;
- Were able to improve mitochondrial viability in the presence of an external toxic insult (glutamate);
- Increased cell health and viability in the presence of an external insult;
- Were more potent than CBD isolate alone in all tests – between 30% and 80%;
- Increased the number of mitochondrial cells without any toxic insult;
- Do not have any negative effects on cell health and maintain cell viability;
- Demonstrate neuroprotective activity in the presence of insult.