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Medlab Granted Ethics Approval to Initiate Clinical Trials

June 19, 2017

 

Earlier today, Medlab Clinical Ltd. (ASX:MDC) announced the company has obtained ethics approval allowing them to proceed with human trials of two cannabis-based medications. 


The Medicines:


NanaBis is a proprietary combination of cannabidiol (CBD) and tetrahydrocannabinol (THC) being developed for advanced stage cancer patients with intractable pain. The study will be conducted at Royal North Shore Hospital’s Northern Sydney CancerCentre and will be looking at the safety, efficacy and tolerability of the drug. These trials will form the basis of an TGA Special Access Scheme (SAS) application to enable prescription by specialist doctors.

 

For those not familiar with Australian pharmaceutical regulations, the Special Access Scheme enables specialists or general practitioners (depending on the nature of product and type of application) to prescribe products that aren't listed on the Australian Register of Therapeutic Goods (akin to FDA Approval in the U.S.) on a case by case basis. 

 

MedLab Clinical's trials of NanaBis come at an interesting time in the world of pain therapeutics. Given the increasing controversy of Opioid based painkillers in the U.S. and globally, alternatives (including cannabinoid-based products) are becoming increasingly sought after. 

 

Medlab Clinical is also initiating human clinical trials of NanaBidial for the indication of chemotherapy induced nausea and vomiting. NanaBidial is comprised of cannabidiol (CBD) derived from marijuana. The study will be looking at safety in healthy individuals (phase 0). This trial will put Medlab on the path towards Special Access Scheme approval that would enable general practitioners to prescribe the product. 


Market Reaction 


In Monday's trading on the ASX, shares of Medlab Clinical gained 3.145%, closing the day at $0.820 AUD. Trading volume today was more than three times the company's 30-day average volume!


View the original ASX announcement here


Conclusion

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