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As a medicinal cannabis company focused on evidence-based science to boost its sales prospects, Medlab Clinical (ASX: MDC) has announced a major milestone today.
A clinical trial of Medlab's flagship NanaBis mouth spray at the Royal North Shore Hospital (RNSH) in Sydney has been deemed safe and efficacious by an independent reviewer.
The reviewer found meaningful pain reduction was achieved for the total cohort of 30 patients suffering from breast or prostate cancers with bone metastasis.
An average improvement of 40 per cent improvement was recorded over the baseline, while adverse events were described as "predominantly mild or moderate and expected".
NanaBis itself is a purified, standardised blend of CBD and THC delivered through the company's proprietary NanoCelle platform.
Following the trial, the majority of patients have elected with Professor Stephen Clarke's approval to continue the NanaBis treatment free-of-charge.
Medlab Clinical CEO Dr Sean Hall says with a strong trial design involving a professional and a strong clinical trial team and collaborators, there is now evidence that NanaBis is safe, tolerable and provides a significant benefit in managing pain associated with metastatic cancers.
"There were a number of notable secondary gains, one of the biggest worth mentioning was a drastic reduction of breakthrough medication used by those patients with breast or prostate cancers with bone METs," says Hall.
"We can confidently argue, NanaBis has a strong indication for use in pain management and is a compelling therapy for this patient group."
Medlab's director of medical research Professor Luis Vitetta reiterates the clinical study using NanaBis in advanced cancer pain management has proven to be safe.
"Furthermore, the results relevant to pain management provides information that allows progression to the next phase of NanaBis' development," says Vitetta.
"The design of a robust Phase 3 clinical study and it's successful completion will advance the path toward registration for NanaBis, as an alternative analgesic medication."
Medlab will now undertake secondary analysis of the data whilst canvassing with various global regulatory agencies in preparation of the forthcoming Phase 3 clinical trials.
MDC shares were up 13.33 per cent at $0.255 at 10:45am AEDT.
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