Neurotech International Limited (ASX: NTI) announced Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) scheme clearance by the Therapeutic Goods Administration (TGA) to commence a Phase I/II clinical trial investigating the use of NTI164 in paediatric patients with Spastic Diplegia Cerebral Palsy (Spastic CP) the most common form of CP, representing up to 80% of cases.
CP is the leading cause of childhood disability.
Approximately 750,000 children and adults in the United States have CP.
In Australia, there are approximately 34,000 persons living with CP.
The Phase I/II trial is proposed to be a single-arm, open-label clinical trial that will recruit up to 14 paediatric patients with a clinical diagnosis of Gross Motor Function Classification System (GMFCS) severity of 2-3, non-ambulant Spastic CP patients to determine the efficacy and safety of NTI164 in these patients from baseline to twelve (12) weeks of treatment with NTI164.
The trial intends to enrol patients at Monash Medical Centre. The primary endpoint of the trial is the Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD©) Questionnaire, which evaluates caregivers’ perceptions of health-related quality of life (HRQOL) and caregiver impact in children with CP.
Secondary endpoints include safety and the effect of Nti164 on pain, sleep, seizure frequency,dystonia (involuntary muscle contraction) and spasticity.
The Lead Investigator of the trial is Professor Michael Fahey, Head of the Paediatric Neurology Unit and Director of Neurogenetics at Monash Medical Centre, Victoria, Australia. Professor Fahey has significant experience with NTI164 having led both Neurotech’s Phase I/II and Phase II/III clinical trials in autism.
NTI164 is a proprietary drug formulation derived from a unique cannabis strain with low THC (M<0.3%) and a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB and CBN.
NTI164 has been exclusively licenced for neurological applications globally.
Pre-clinical studies have demonstrated a potent anti-proliferative, anti-oxidative, anti-inflammatory and neuro-protective effects in human neuronal and microglial cells.
NTI164 is being developed as a therapeutic drug product for a range of neurological disorders in children where neuroinflammation is involved.
Dr Thomas Duthy, Executive Director of Neurotech International -
“We are pleased to have received HREC clearance for this important clinical trial of NTI164 in children with spastic CP. Although there are a variety of drug therapies used in the treatment of spastic CP, they are often associated with sedation, confusion, memory loss, and attention deficits. For first-line treatment with oral Baclofen the actual evidence of efficacy remains somewhat subjective and not necessarily supportive of widespread use in spastic CP.1 Accordingly, we see NTI164 as potentially a new breakthrough treatment as part of the clinical armamentarium to treat CP spasticity more effectively noting improvements in gross motor function, increased participation at a social level and comfort are considered important treatment goals to improve the overall quality of life of the individual.”
The Phase I/II clinical trial will be registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) under registration number in due course.