Health: Medlab proves pot reduces a very specific kind of cancer pain
Health & Biotech
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Cannabis can reduce breast and prostate cancer pain by well over a third, according to results from a phase one clinical trial by Medlab Clinical (ASX:MDC).
Medlab says all patients had meaningful pain reduction, but those with breast and prostate cancers that had spread to the bone had an average of 40 per cent improvement in pain scores from baseline.
The regulatory threshold for new pain medications is a 30 per cent improvement above baseline.
Furthermore, the breast and prostate cancer sufferers needed to take significantly less opioid medication to get to that result.
Results from Medlab’s advanced cancer pain trial using its 1:1 THC:CBD mouth spray met its primary and secondary endpoints for safety and tolerance at 60 per cent of the maximum dose, as well as caused meaningful pain reduction.
The trial using NanaBis, conducted at the Royal North Shore Hospital with principal investigator professor Stephen Clarke, was a stage one Single Ascending Dose and a stage two Multiple Ascending Dose investigation into pain management of patients with metastatic — rapidly spreading — cancers.
The 30-day trial covered 30 patients with advanced cancer who were already taking opioid painkillers. Two-thirds were women and one third had breast and prostate cancers that had metastasized into the bone.
The way the trial was designed, with endpoints looking at safety and efficacy mean Medlab can now go straight into a broader phase three trial.
Medlab CEO Sean Hall says the phase three trial will recruit about 306 people and end in 2022, followed by drug registration in 2023. It will, at this stage, include three sites in Australia and one in the US, where Medlab is currently pursuing the first stage of Food and Drug Administration (FDA) approval of Investigational New Drug status.
Human clinical trials are done over three phases, with phase one testing whether a drug is safe, phase two looking at whether it works in small populations, and phase three looking at whether it works in larger populations. Phase four trials come after a drug is registered and use real-world use data.
Medlab plans to focus its next steps on metastatic bone pain where breast or prostate are the primary cancers, and looking to make it an alternative painkiller to opioids rather than an adjunct to existing opioid analgesics.
Hall says there are few painkillers that can treat “crippling bone pain” for these cancers.
But he says the market is not large — only an estimated 600,000 patients in the US, Canada, Europe and Australia. However, they are living longer and estimates suggest the UK, France, Germany and China are expected to be growth markets by 2030.
Cannabis limits the stimulation of different pain nerves.
Hall says the drug delivery platform sends the active pharmaceutical ingredient (API) in via the mouth surface, or oral buccal mucosa, to the facial emphatics which is a “super transport highway in the body”. It meant the APIs were released in 54 minutes.
Hall cited research suggesting cannabinoids ingested via the gut were absorbed slowly and erratically, typically hitting peak release after four hours, and only about 6 per cent of the API made it into the body.
Telix Pharmaceuticals (ASX:TLX) has engaged professor Dr Frederik L Giesel from the University of Heidelberg (Germany) to join its Scientific Advisory Board. He will advise Telix in relation to its R&D and clinical development activities spanning the company’s prostate cancer, kidney cancer and glioblastoma (brain cancer) programs.
Immutep (ASX: IMM) has had an Investigational New Drug application approved by the FDA for eftilagimod alpha, allowing it to initiate a planned phase one clinical study in metastatic breast cancer patients.