Medlab Clinical (ASX:MDC) says it has received the results from an Independent Reviewer for the NanaBis advanced cancer pain trial conducted at the Royal North Shore Hospital (RNSH) with principal investigator Professor Stephen Clarke.
The clinical trial was a Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) investigation into pain management of patients with metastatic cancers (n=30).
The company said NanaBis met the primary endpoints of safety and tolerability, as well as efficacy, and secondary endpoints including pain reduction.
NanaBis is a 1:1 purified and standardised blend of cannabidiol (CBD) and tetrahydrocannabinol (THC) delivered by Medlab's (MDC) NanoCelle platform.
"The trial was designed to accelerate the traditional phased trial pathway through typical Phase 1 and Phase 2 programmes," said the company. "The result is a robust trial that has delivered strong results allowing MDC to focus on Phase 3 designs, specifically in the patient group with metastatic bone pain where breast or prostate are the primary cancers."
The company said that, since the completion of the trial, the majority of patients have elected and been approved by Professor Stephen Clarke to continue on NanaBis.
According to Medbaln CEO Dr Sean Hall, “With a strong trial design, that involved a professional and strong clinical trial team and collaborators, today we have primary evidence that NanaBis is safe, tolerable and provided 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 (metastases).”
“We can confidently argue, NanaBis has a strong indication for use in pain management and is a compelling therapy for this patient group,” added Dr Hall.