Phase 2 Epilepsy Clinical Trial Update
PhytoTech Therapeutics’ first Phase 2 clinical trial, which commenced in February 2017, is continuing as planned. This clinical trial is an open-label study aimed at evaluating the safety, tolerability and efficacy of oral administration of PTL101 as an adjunctive treatment for children with refractory epilepsy. The PTL101 drug beads are utilising proprietary formulation developed through the Company’s Gelpell-CBD™ product technology contain organically derived, highly purified cannabidiol (CBD). To date, 9 patients have been enrolled and 2 patients have completed the study. Patients are continuing to be screened for study entry and we expect to complete recruitment in a few months, to a total of 15 patients with intractable epilepsy, on stable doses of antiepileptic drugs (AEDs).
Patients begin with an initial dose of 50 mg CBD, which is then elevated (at increments of 50 mg) until reaching a stable dose, individually determined based on seizure frequency and adverse events. The efficacy measurements in this study will assess the seizure frequency, the global impression of seizure severity and the global impression of improvement in the patient’s clinical condition during treatment.
Epilepsy is one of the most common neurological disorders in children, with a point prevalence of 6.3 per 1,000 currently diagnosed children. Based on these rates, it is estimated that 466,000 childhood patients in the United States and 765,000 patients in Europe are currently diagnosed with epilepsy. While approximately 70% of patients achieve long-term remission of at least five years, the remaining patient population suffers from inadequate control of seizures with currently available treatment options. Approximately 3% to 3.5% of Australians will experience epilepsy at some point in their lives and over 250,000 Australians are currently living with epilepsy, with children being approximately 40% of the epilepsy patient population.
Cannabidiol (CBD), one of the principle active components of cannabis extract, has been shown to modulate the human endocannabinoid system and has been shown to create anticonvulsant, anxiolytic, antipsychotic, antiemetic and anti-inflammatory effects in experimental models. An optimal oral dosage form is not yet available due to the substantial “first pass” metabolic effect, which limits the oral bioavailability of cannabinoids to 6%. In our phase 1 study, the Gelpell-CBD™ capsules showed increased oral absorption compared to an oromucosal spray. We hope the oral capsules will become a simplified dose delivery technology for both doctors and patients.