Results from an advanced cancer pain clinical trial using NanaBis oro-buccal spray developed by Medlab Clinical (ASX: MDC) has found the novel drug candidate to be safe, tolerable and fast-acting with mild adverse effects.
The trial at Sydney’s Royal North Shore Hospital was a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) investigation into pain management of patients with advanced metastatic cancers.
It involved the buccal (side of cheek) administration of NanaBis as an adjunct to opioid analgesics for the management of intractable pain and had safety, tolerability and exploratory primary end-points.
Meaningful pain reduction
The results found NanaBis to be safe and well tolerated by the study cohort, with tolerance achieved at 60% of the maximum dosage.
It was also demonstrated to be fast-acting, with the total cohort experiencing “meaningful pain reduction” and a patient subset of breast or prostate cancers with bone metastasis having an average of 40% improvement in pain scores from baseline.
The same subset showed significantly less morphine milliequivalent (MMEq) of dispensed opioid analgesics prescribed, than the remaining cohort.
Medlab chief executive officer Dr Sean Hall said the robust trial delivered strong results which will allow the company to focus on the next phase of development.
“We [now] have primary evidence that NanaBis is safe, tolerable and provides a significant benefit in managing pain associated with metastatic cancers,” he said.
“We can confidently argue that NanaBis has a strong indication for use in pain management and is a compelling therapy for this patient group.”
Dr Hall said the design and successful completion of a Phase 3 clinical study would advance the path toward registration for NanaBis as an alternative analgesic medication.
NanaBis has been developed as a non-opioid alternative for effective pain management and is a 1:1 purified and standardised blend of cannabidoil (CBD) and tetrahydrocannabinol (THC) delivered in Medlab’s proprietary platform NanoCelle.
In January, Medlab signed a commercial agreement with Tasmanian Alkaloids Pty Ltd for the manufacture and release of NanaBis for global supply.
The research and development company specialises in the extraction and purification of high-value plant-derived products for the pharmaceutical industry.
It recently added medicinal cannabis products and services to its portfolio including cultivation, manufacturing, formulation, analytical and release for supply.
Advanced metastatic breast or prostate cancers have a high unmet medical need, with conservative research in 2017 suggesting almost 600,000 patients exist across the US, Canada, Europe and Australia.
Studies show population numbers for both cancers are growing and survival rates are improving, meaning patients may have to live with pain for longer than before.
Inadequate control of chronic pain is believed to be a major contributor to disease burden in approximately half of cancer patients.
Opioids are used widely to treat pain but research suggests some of them may promote cancer progression.
Since the completion of Medlab’s trial, the majority of study participants have elected and been approved by principal investigator and medical oncologist Professor Stephen Clarke to continue on NanaBis free of charge.
At midday, shares in Medlab Clinical were up 10.87% to $0.255.