The Phase I/II clinical trial announced today is a groundbreaking study where medicinal cannabis containing little to no THC is being tested on autistic children.

Neurotech International (ASX:NTI) has now started the world’s first study to assess full spectrum medicinal cannabis containing little to no THC, in children with autism.

The company announced that it has begun a Phase I/II open label clinical study in 20 children aged between 5-17 years with Autism Spectrum Disorder (ASD).

The study is conducted to evaluate the safety and efficacy of orally administered NTI/DOLCE full spectrum medicinal cannabis plant extract in the patients – and measure outcomes relating to behaviour, agitation and irritability as well as quality of life.

Results from this study will be used to plan future Phase II/III studies.

World’s first

This Phase I/II study is an open label clinical study in 20 children aged between 5-17 years with ASD, conducted under the guidance and supervision of Professor Michael Fahey, head of Paediatric Neurology at Monash Children’s Hospital.

It will be the first time that a full-spectrum of less than 0.3% THC medicinal cannabis strains will be assessed in ASD.

The NTI/Dolce lead strain (FEN 164) will assess key behaviours in ASD over 16 weeks, including a four-week washout period where no treatment is given.

“Medicinal cannabis has the potential to provide this treatment, but only NTI/Dolce naturally derived strains offer full-spectrum CBDs with little to no THC, an important consideration when treating children,” says Brian Leedman, chairman of Neurotech.

In the study, daily administration of NTI/Dolce FEN 164 will be delivered in a neutral tasting oil system.

The study follows promising results in vitro studies which demonstrated that the NTI/Dolce strains, with the newly discovered rarer cannabinoids CBDP and CBDB, have powerful, unique properties that extend beyond CBD.

Amongst others, that study concluded that the NTI/Dolce strains reduce inflammation within the brain cells, and have more potency than CBD isolate alone in all tests – of somewhere between 30% and 80%.

The study also found that the strains increase neuro-regulatory and neuro-modulatory activities, with no negative effects on cell health.

“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,” Leedman added.

What’s next

The Phase I/II study will be coordinated and managed using centralised medical databases systems, with interim results and updates to be provided throughout.

All patients will be monitored and assessed by Professor Fahey and his team, which comprise senior autism and behavioural clinical psychologists.

Neurotech’s Mente device, which is the company’s first device used to help relax the minds of children with ASD, will also be assessed during the study.

Neurotech says that it has begun discussions with the TGA and other relevant regulatory agencies, for the therapeutic expansion and registration of these novel full spectrum plants.

The company also says that going forward, it will continue with further in vitro study research in respect to other neurological disorders, as part of its ongoing research and development program.

This article was developed in collaboration with Neurotech International, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.