Neurotech International Limited (ASX:NTI) has commenced a Phase I/II open label clinical study in 20 children aged between 5-17 years with Autism Spectrum Disorder (ASD).

This much-anticipated study is being conducted under the guidance and supervision of A/Professor Michael Fahey, Head of Paediatric Neurology Monash Children’s Hospital.

It will be the first time full-spectrum <0.3% THC medicinal cannabis strains will be assessed in ASD, and NTI/DOLCE lead strain (FEN 164) will assess key behaviours in ASD over 16 weeks including a 4-week washout period (no treatment).

Neurotech’s progress in this area hasn’t gone unnoticed over the last 12 months with the company’s shares up 700% over that period.

However, a slight retracement in April may just have thrown up a useful entry point for investors looking to take advantage share price catalysts that could emerge as a result of the study.

On this note, investors can expect to receive updates throughout the course of the study, suggesting there could be near-term market sensitive news.

Platform for study established through in vitro findings

Importantly, Neurotech embarks on the study with valuable research already suggesting that the NTI/Dolce strains, with the newly discovered rarer cannabinoids CBDP and CBDB, have powerful, unique properties that extend beyond CBD alone.

For example, results that have been observed include reduced inflammation with the brain cells and increased cell health and viability.

The strains displayed more potency than using CBD isolate alone with outperformance ranging between 30% and 80%.

In terms of efficacy, the company has not observed negative effects on cell health.

Commenting on the rigorous nature of the upcoming study, Fahey said, “It is exciting to undertake a properly planned and executed study on a novel CBD product.

‘"Many other studies do not have the rigor to ensure that the results are translatable to evidence-based clinical treatments.”

Commencement of discussions with TGA

Neurotech has commenced discussions with the TGA and relevant regulatory agencies for the therapeutic expansion and registration of these novel full spectrum plants.

Studies have been designed to assess dose escalation, efficacy and a 4-week wash-out period.

All patients will be monitored and assessed by Fahey and his team which comprises senior autism/ behavioural clinical psychologists.

The company’s Mente device will also be assessed in combination with the NTI/Dolce medicinal cannabis strains.

Discussing the significance of the potential outcomes in terms of quality of life, Neurotech chairman Brian Leedman said, "This is a very exciting and novel approach to the treatment of ASD for which there is the need for safe, effective therapies with no side effects that can improve a patient’s quality of life.

"Medicinal cannabis has the potential to provide this treatment, but only NTI/DOLCE naturally derived strains offer full-spectrum CBDs with no THC, an important consideration when treating children”.

Further reading: NTI Begins Autism Clinical Trials for Unique Cannabis Strain