Australian-based MMJ PhytoTech's Israeli division PhytoTech Therapeutics has initiated the Health Authorities-approved Phase II clinical trial of PTL101 capsules to treat refractory epilepsy in children.
Developed using MMJ's Gelpell-CBD product technology, the PTL101 capsules contain organically derived and purified cannabidiol (CBD) packed in natural gelatin beads under 2mm.
With maximised surface-to-volume ratio, the gelatin matrix pellets dispense over the gastrointestinal (GI) system to ensure a constant GI-transit time.
The open-label, single-centre Phase II trial is designed to evaluate the safety, tolerability and efficacy of oral PTL101 as an adjunctive treatment to refractory epileptic children.
MMJ PhytoTech managing director Andreas Gedeon said: “The commencement of the Phase II clinical trial of our PTL101 capsules is a key step towards the potential commercial development of the capsules for treating refractory epilepsy in children.
"Importantly, the Phase II clinical trial has the potential to serve as a significant value catalyst for MMJ’s shareholders in addition to the Harvest One transaction, which has been strongly supported to date.
"We look forward to providing our shareholders with updates on the progress of our Phase II clinical trial, in conjunction with further updates from our Duncan Facility in Canada, as we ramp up production over coming months.”
The trial will establish efficacy endpoints such as the seizure frequency and global impression of improvement in patient's clinical condition after the treatment with PTL101.
A Phase I study conducted last year to evaluate the safety and performance of the Gelpell-CBD capsules showed the effective delivery profile of CBD compound in the subjects.