The Trial was a single-centre, multi-arm, randomised, crossover study to assess the safety, tolerability and pharmacokinetics (cannabinoid dose and profile in the blood) undertaken at the Sourasky Medical Clinical Research Center, a highly regarded clinical site in Israel. The trial was focused on the study of two of the Company’s THC:CBD Pro-Nano-Lipospheres (PNL) oral capsules licensed from Yissum.
The study was designed to fulfil all the regulatory requirements needed for the New Drug Application (NDA) to the Food and Drug Administration (FDA).
The trial involved administering dosages of MC to 15 healthy volunteers of two oral THC:CBD formulations in comparison to Sativex, the leading oromucosal MC spray of GW Pharmaceuticals.
Phase 2 Clinical Study on Multiple Sclerosis
Following the successful completion of the Phase 1 Trial, MMJ plan to undertake a Phase 2 Trial commencing in the second half of 2016. The Phase 2 Trial will assess the efficacy of the oral capsules for treating pain and spasticity in patients who suffer from multiple sclerosis, with results expected in the first half of 2017.
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