There was big news from Medlab Clinical, after the company announced an "impressive start" to the progression of its Australian approved Ethics Observational Study for NanaBis.
The second round of the MedLab Clinical Ltd (ASX: MDC) NanaBis study was previously given Ethics approval for an Observational Study to assess real world use of the drug on 18 June 2019.
The study is intended to provide further clinical evidence of the safety and tolerability of NanaBis as a prescriptive medicine for patients suffering from chronic pain. If the trial is successful, it will significantly bolster the company's ultimate goal of receiving drug registration for NanaBis.
The study is part of the company's ongoing commitment to clinical research as a pathway to drug registration for NanaBis, which also includes a study at The Royal North Shore Hospital in Sydney that is currently close to completion.
An observational study on the safety, tolerability and efficacy of Medlab's cannabisbased medicine NanaBis™ is providing extremely noteworthy and very encouraging results for the effective management of pain, as well as the future development of the company's cannabis-based medicines.MedLab Director of Medical Research, Professor Luis Vitetta
Due to the sensitivity surrounding patient data, MedLab has spent the last 12 weeks operating under a soft launch to further refine the process around data collection, transport and management.
The CEO of MedLab, Dr Sean Hall, described the Observational Study as being, "critical in understanding real world use, dosing in relation to other prescribed medications and any potential effects to the patient."
"The study is a unique vehicle protecting Medlab, the Doctor and patient under an Ethics agreement. Moving forward, we are very optimistic as to the NanaBis benefit for the assumed patient cohort," he said.
Earlier today MedLab announced that it has completed its first monitoring process as part of the Study Protocol and is extremely pleased with results to date.
Thus far, over 100 Australian doctors signed on to participate in the study, while more than 200 Australian patients—representing 10% of the expected cohort—have also been successfully recruited into the study. The average age of the study's participants is 56 years old, while 66% of patients are female.
The study's dosage guidelines have been set at two sprays per day—which is a significantly lower dosage model than the one used in the RNSH NanaBis—while 50% of the participants currently suffer from neuropathic pain.
As of 2 December, all patients involved in the study have reported a noticeable reduction in pain.
The company expects to officially launch the Observational Study on a nationwide scale in January.
To learn more about MedLab Clinical visit their Company HQ here.
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