MMJ PhytoTech’s Israeli division PhytoTech Therapeutics has obtained approvals from Ministry of Health and the Sheba Hospital regulatory body Helsinki, to initiate a Phase II clinical trial of its PTL201 for the treatment of spasticity related symptoms in patients with multiple sclerosis (MS).
Formulated with the firm’s Gelpell-CBD product technology, PTL201 contains a combination of tetrahydrocannabinol (THC) and cannabidiol (CBD).
THC and CBD are bound to and covered by gelatin matrix beadlets that are packed in gastro-resistant capsules.
The double-blind, randomised, placebo-controlled, parallel-group, single-centre Phase II trial is designed to assess the safety, tolerability and efficacy of oral PTL201 in 70 patients with spasticity related symptoms.
MMJ PhytoTech managing director Andreas Gedeon said: “PhytoTech Therapeutics is continuing to implement our ambitious clinical development plan, which is the result of our group’s synergistic global positioning and our focus on science-based product development in the medical cannabis field.
“The current PhaseII clinical trials have the capacity to create significant value for our shareholders, not only on their stand-alone merits in the pharmaceutical development chain, but also by supporting the commercialisation of Satipharm’s Gelpell products, which have been exclusively licensed to Phytotech Therapeutics in the Rx fieldon a royalty-free basis, for the international medical cannabis and dietary supplement markets.”
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The change in spasticity numerical rate scoring (sNRS scores), walking velocity and clinical global impression improvement (CGI-I) will be measured as the efficacy endpoints during the trial.
The trial will also evaluate other parameters such as the improvement of spasm frequency, sleep disturbance and decrease in pain.