Details on IHL clinical trials

Hi everyone,

I have been seeing a lot of questions raised in regards to the clinical trials recently, so I thought I would just set the record straight by providing some information and insights from my research.

For starters, if you're unfamiliar with the procedures, I would suggest you to have a read at the guidelines and requirement on running a clinical trial in Australia as it's a very complicated and time consuming process.
https://www.australianclinicaltrials.gov.au/researchers/getting-started

For a trial to officially begin, ethical approval is necessary and this involves application with a Human Research Ethics Committee (HREC). This process can often take weeks or even months depending on outcome of their meetings, which is normally held once a month.
https://www2.health.vic.gov.au/about/clinical-trials-and-research/health-and-medical-research/how-to-make-an-hrec-application-and-reporting

Importance of ethics review: https://www.australianclinicaltrials.gov.au/_files/elearn/module-2/02-the-importance-of-ethics-review.html

IHL, in partnership with Cannvalate and AXIM, currently has 2 of their 4 proposed clinical trials registered under the Australian New Zealand Clinical Trial Registry (ANZCTR).

#1 - Periodontitis trial
"A phase 2a randomised controlled trial investigating the effect of CBD (cannabidiol) toothpaste and mouthwash on gingivitis versus placebo in healthy volunteers"

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377742&isReview=true

Date Registered: 21/06/2019
Trial Duration: 35 days
Recruitment Target: 40


Ethics Committee: Bellberry HREC
https://bellberry.com.au/about-us/hrec/

I have personally contacted the person in charge at Swinburne University for some details as I was initially interested in participating in the trial, unfortunately I did not meet their criteria but I was told that they have just submitted their ethics application for the gingivitis trial. Bellberry hosts their meeting every Wednesday evening, so we should hear some feedback from it very soon in my opinion.




#2 - Sleep Apnoea trial
"A Phase 2a randomised controlled trial measuring the effects on apnoea hypopnoea index (AHI) with nocturnal IHL-42X versus placebo in adults with obstructive sleep apnoea (OSA)"

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378058&isReview=true

Date Registered: 09/08/2019
Trial Duration: 6 weeks
Recruitment Target: 30


Ethics Committee: Austin Hospital HREC
http://www.austin.org.au/ResearchEthics/HREC/

Austin Health currently hosts their meetings for ethics once a month, the next meeting (CRRC) is scheduled on 18/09 at 12pm, which also aligns with the anticipated date for ethics submission of the sleep apnoea trial.


In regards to the article published on the Australian recently stating that "the outcomes of the four clinical trials are expected before the end of the year", I found the statement itself to be vague and misleading, as we know that it all comes down to when ethical approvals are in place and finalisation of patient recruitment. Collecting data also requires a significant amount of time as we can see from the reports above, anticipation dates of last data collection are Jan 2020 and May 2020 for the periodontitis and sleep apnoea trials respectively.

In my opinion, we are likely to see initial feedback from the first group of recruitment once their trials have ended (35 days from recruitment) hopefully by years end, however we won't be seeing full results and outcome until at least early next year, so it's important to keep your expectations realistic.
https://impression.healthcare/wp-content/uploads/2019/09/Australia-on-a-high-in-cannabinoid-research-The-Australian-972019.pdf

Finally, I have also emailed CEO Joel Latham with some questions, he has confirmed that they are currently working closely with AXIM, Cannvalate and HREC for ethical approvals, and are making "positive inroads". When asked how quickly does he anticipate products to go into market once the trials are successful, he replied saying that the company already have supply and manufacturing agreement in place, but will need to follow standard regulatory steps with import permits etc. A rough estimate is that he expects the toothpaste and mouthwash products to be ready for sale on market 4-6 weeks following a successful clinical trial.

Hope this info helps.

Hez