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MEDICINAL CANNABIS 71 NanaBis clinical trial Regarding the NanaBis clinical trial, Dr Hall said: “We’re very much accelerated and at that cusp where it’s safe to say we’re entering a more mature stage of the program. “In March this year, we publicly announced data from the Royal North Shore \\\\\\\\\\\\\\\[Hospital, Sydney\\\\\\\\\\\\\\\] trial – a trial in unhealthy patients. They were all advanced cancer patients with \\\\\\\\\\\\\\\[significant\\\\\\\\\\\\\\\] pain. The data set is really good. We’ve got a publication that we’re just finishing off now and we’ll go to the review committee for publication shortly. “We have a very strong signal from the Royal North Shore data on when NanaBis is best indicated and we’re chasing that now. And at this point in time we’re working with the \\\\\\\\\\\\\\\[US\\\\\\\\\\\\\\\] FDA \\\\\\\\\\\\\\\[Federal Drug Administration\\\\\\\\\\\\\\\] on moving to an IMD ... for early next year, hopefully, all being well. And it’s an aggressive time period, \\\\\\\\\\\\\\\[but\\\\\\\\\\\\\\\] being that we’re good to go, \\\\\\\\\\\\\\\[we plan\\\\\\\\\\\\\\\] to start initiation and recruitment for a global multicentred petri trial to do that final efficacy step before we gap fill and go for a new drug application.” Medicinal cannabis manufacturing Dr Hall became involved with medicinal cannabis following a personal experience with the debilitating effects of cancer and cancer therapy. “That’s a bit of a personal story,” he said, recalling the death of his brother, Alex. “We can argue that Alex went before his time. The reality was that Alex had two significant bouts of neuro \\\\\\\\\\\\\\\[neurological cancer\\\\\\\\\\\\\\\]. The first one was around his 21st birthday and we were able to excise it through very strong chemo \\\\\\\\\\\\\\\[chemotherapy\\\\\\\\\\\\\\\]. He probably lived eight years’ borrowed life beyond that. “The problem was that it came back. It mutated. It was non-operable ... I got to see firsthand just how useless, I suppose, my medical training was. And in my mind, the epilepsy and the pain had a vast impact on Alex. It would do things like prevent him from eating, sleeping, getting out of bed. It was a horrible thing to see.” This devastating experience allowed Dr Hall to see that there may be “significant deficits in oncology- related care”. While oncology care provided to patients is the best currently possible, he says, “when it’s personal, the best is not enough”. “After we put Alex to rest, I realised where I can probably make an influence, and at that point I was already looking at cannabis ... in the aspect of pain ... \\\\\\\\\\\\\\\[and\\\\\\\\\\\\\\\] I just figured, it’s an area ripe for innovation.” This was the beginning of the road towards NanaBis, which today “is seen as \\\\\\\\\\\\\\\[Medlab Clinical’s\\\\\\\\\\\\\\\] lead program”, he says. “The hope is when we have a pain- related cancer or cancer-induced bone pain or bone metastasis resulting from a primary tumour, that maybe for other people we can do something – to buy them that ... time where standard oncology practices can actually weigh in and do significantly more benefit to the patient,” Dr Hall said. “NanaBis is an equimolar CBD THC in a proprietary delivery platform called NanoCelle – it’s sublingual. So, what we normally do is, via a precise actuator, apply a spray to the buccal membrane. The NanoCelle environment is optimised to pass that membrane, and then we utilise facial lymphatics to take the drug systemic very quickly.” Dr Hall says the benefits of manufacturing medicinal cannabis synthetically include the safety and standardisation that comes with not touching the leaf. “We don’t leaf touch,” he said. “We’re less concerned about the grow, and more concerned about turning that biomass to a standardised, purified crude, then tolling that crude into the NanoCelle environment that thus produces NanaBis. “We fundamentally understand the product \\\\\\\\\\\\\\\[including titration requirements\\\\\\\\\\\\\\\]. We fundamentally understand where it can elicit positive outcomes and what they look like. We know how to titrate accordingly. This puts us leaps and bounds beyond the majority of global cannabis companies out there. “We’ve got a patented delivery platform. We’ve had the product available under compassionate use for just over a year and a half now ... we’re doing further studies to try and determine potential abuse – potential adverse events that are different to what we’ve seen in the study cohorts. \\\\\\\\\\\\\\\[We’re looking\\\\\\\\\\\\\\\] at pharmacotherapy – whether that produces any contraindications, and looking at how the drug is used and potentially surrogated in world standards. That’s another ethics approved study that’s currently running in Australia.” Dr Hall continued: “The big differentiation between us and the guy down the street that’s selling a medical cannabis product is, I think, \\\\\\\\\\\\\\\[that\\\\\\\\\\\\\\\] going down the clinical trial route forces you into a situation where you either have to put up or shut up. The trial outcomes start to dictate, really, that efficacy model. “My take is, from a pharmacist and a medical point of view, you want to prescribe with some level of confidence. I think there are only three or four companies here who are taking the proper clinical trial route as opposed to some people who might be doing a bit more of a marketing trial. “But our goal in the end is a registered drug. That’s where we see this, and that comes with risks, but as a company in that biotech space, especially in that early discovery space, risk is kind of a cultural norm for us.” The role of a pharmacist While dispensing of medicinal cannabis is largely the domain of approved prescribers and doctors who have received approval through the SAS, given the potential change in low-dose CBD scheduling, all pharmacists will soon play a role within this arena, and will need to know how to dispense medicinal cannabis appropriately, and according to health conditions. Mr Sclavos says all pharmacists will “need to step up”. Dr Jansen said: “\\\\\\\\\\\\\\\[At present\\\\\\\\\\\\\\\] CBD is a Schedule 4; THC is a Schedule 8 – any product that has more than two per cent of any other cannabinoid apart from CBD is considered a Schedule 8 as well,” he said. “The government is looking to change the scheduling of smaller bottles of CBD to across-the- counter pharmacy only (Schedule 3) ... so \\\\\\\\\\\\\\\[if this goes ahead\\\\\\\\\\\\\\\] pharmacists would have more of a role in dispensing CBD ... \\\\\\\\\\\\\\\[and\\\\\\\\\\\\\\\] would need to give accurate advice,” said , adding the need for pharmacists to upskill in this area. “We do have pharmacists referring onto us and ... we try to support our TO PAGE 72 RETAIL PHARMACY • AUG 2020