Medlab Clinical Ltd (ASX:MDC) has received independent review results for the NanaBis™ advanced cancer pain trial confirming that it was safe, tolerable and provided a major benefit in managing pain associated with metastatic cancers.
These results from an independent reviewer for the trial conducted at Royal North Shore Hospital in Sydney saw the company's share price increase 24% in early trade to an intra-day high of 28 cents.
The clinical trial was a single ascending dose (SAD), multiple ascending dose (MAD) investigation into pain management of patients with metastatic cancers with the NanaBis™ blend of cannabidiol (CBD) and tetrahydrocannabinol (THC).
Medlab chief executive officer Dr Sean Hall said: “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.”
The trial was ethics approved by the Kolling Institute, was given a Clinical Trial Number (CTN) by the Australian Federal Government and was listed in accordance to CTN guidelines on the Australian New Zealand Clinical Trial Registry.
Primary endpoints met:
- NanaBis™ is safe;
- NanaBis™ is tolerable - dosage tolerance achieved at 60% of maximum dosage;
- NanaBis™ is efficacious;
- Adverse events were predominantly mild or moderate and expected;
- NanaBis™ is demonstrated to be fast-acting as it showed time to with maximum concentration in serum to be 54 minutes; and
- Improvements in Quality of Life (QoL) measures, specific in role and emotional functioning and insomnia.
Secondary endpoints met:
- Total cohort had meaningful pain reduction, a specific patient subset being breast or prostate cancers with bone metastasis had an average of 40% improvement in pain scores from baseline;
- Breast or prostate cancers with bone metastasis showed significantly less morphine milliequivalent (MMEq) of dispensed opioid analgesics prescribed, than the remaining cohort; and
- No change in number of rescue medication doses during the course of the trial.
Notable results for pain relief
NanaBis™ was shown to be effective, safe, tolerable (dosage tolerance achieved at 60% of maximum dosage), and fast-acting with any adverse events predominantly mild, or moderate, and expected.
Improvements in quality of life measures showed the drug has a specific role in emotional functioning and insomnia.
Hall said: “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 metastasis."
This patient group had an average of 40% improvement in pain scores from baseline and showed significantly less MMEq of dispensed opioid analgesics prescribed, than the remaining cohort.
Hall said: “We can confidently argue, NanaBis™ has a strong indication for use in pain management and is a compelling therapy for this patient group.”
Next phase for NanaBis™
The trial was designed to accelerate the traditional phased trial pathway through typical phase one and phase two programs, with strong results allowing the company to focus on phase three designs in the patient group with metastatic bone pain where breast or prostate are the primary cancers.
Medlab director of medical research Professor Luis Vitetta said: “The completion of Medlab’s SAD/MAD clinical study with NanaBis™ in advanced cancer pain management has proven safe.
“Furthermore, the results relevant to pain management provides information that allows progression to the next phase of NanaBis™’ development.
“The design of a robust phase three 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 for phase three clinical trials.