MMJ PhytoTech to initiate Phase II trial of PTL201 to treat MS symptoms

15th May 2017 (Last Updated May 15th, 2017 18:30)

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).

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.

"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.”

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.