Phase 2 Clinical Trial For Treatment of Epilepsy Underway
- Phase 2 clinical trial of PTL101, MMJ's investigational drug, now underway, following completion of successful Phase 1 trial in 2016
- Phase 2 clinical trial is aimed at measuring safety and efficacy of the PTL101 drug-beads for reducing seizures frequency in children with refractory epilepsy
- Successful Phase 2 clinical trial will be a major step towards commercial development of the PTL101 drug for epilepsy treatment
- Preparation for an additional Phase 2 study to treat spasticity related symptoms of multiple sclerosis patients utilising PTL201 is well advanced
The phase 2 study follows the highly successful Phase 1 study (announced 3 March 2016), which highlighted the safety and high performance of the Gelpell-CBD(TM) capsules. The capsules successfully demonstrated the effective delivery profile of CBD compound to trial subjects.
The PTL101 capsules / beads are utilising proprietary formulation developed through the Company's Gelpell-CBD(TM) product technology.
It is estimated that approximately 100,000 children in North America suffer from refractory epilepsy - a treatment resistant category of the disease, causing uncontrollable seizures.
To date, drug therapy remains ineffective in the treatment of epileptic seizures for approximately 30% of refractory epilepsy patients in North America alone, due to the drug failing to control the frequency of seizures or patients not being able to tolerate the related side effects. A number of currently available epilepsy drugs have been found to have significant side effects including the impairment of a patient's motor skills and cognitive abilities.
Phase 2 Clinical Trial Background
The Phase 2 study is an open-label, single-center clinical study to evaluate the safety, tolerability and efficacy of oral administration of PTL101 as an adjunctive treatment to refractory epileptic children.
The efficacy endpoints will assess the seizure frequency and global impression of improvement in patient's clinical condition following the investigational drug-product PTL101 treatment.
The PTL101 drug beads contain organically derived, highly purified CBD (cannabidiol) packed in seamless natural gelatin beads under 2mm that bound and protect the CBD compound. The beads do not contain filling material or emulsifiers which help to avoid irritation of gastric mucosa.
The gelatin matrix pellets dispense over the gastrointestinal (GI) system to achieve a constant GI-transit time. Maximised surface to volume ratio also contributes to enhanced bioavailability. In addition to the above investigational product virtues, the Company is expecting high pediatric patients' compliance as they are going to consume the tasteless tiny beads mixed with foods.
The study will be conducted in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice (ICH E6) and the Code of Federal Regulations on the Protection of Human Subjects (45 CFR Part 46).
MMJ PhytoTech's Managing Director, Andreas Gedeon, commented, "The commencement of the Phase 2 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 2 clinical trial has the potential serve as a significant value catalyst for MMJ's shareholders, in addition to the Harvest One (CVE:WON.H) transaction which has been strongly supported to date.
We look forward to providing our shareholders with updates on the progress of our Phase 2 clinical trial, in conjunction with further updates from our Duncan Facility in Canada, as we ramp up production over coming months."
About MMJ PhytoTech Ltd
In October 2017, MMJ PhytoTech Limited (ASX:MMJ) announced its strategy to become an incubator for strategic investments across regulated jurisdictions globally covering the entire cannabis value chain.
Following the successful listing of United Greeneries Holdings Ltd ("United Greeneries") and Satipharm AG ("Satipharm") on the TSX-V through Harvest One Cannabis Inc. (CVE:HVT), MMJ has focused on the identification of a number of independent strategic investment opportunities that have the potential to deliver significant value to the Company's shareholders.
MMJ is actively pursuing early stage opportunities with the ability to deliver significant future revenue and the opportunity to provide dramatic global synergistic value as regulatory frameworks in key international markets continue to evolve. MMJ is targeting the full range of emerging cannabis-related sectors including healthcare products, technology, infrastructure, logistics, processing, cultivation, equipment, R&D, hemp food products and retail.
MMJ currently holds an equity stake of 53,333,333 shares in Harvest One, 100% ownership of Israeli-based R&D division PhytoTech Therapeutics Limited ("PTL") and strategic holdings in e-Sense Lab Limited (ASX:ESE) and private Canadian-based company WeedMe Inc.
MMJ PhytoTech Ltd
Harvest One Cannabis Inc