Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has announced the extension of the company’s Phase I/II clinical trial investigating the use of NTI164 in female Rett Syndrome patients and an additional HREC approval.
“The extension phase to 52 weeks of daily oral treatment with NTI164 was approved by Westmead’s Human Research Ethics Committee under the clinical trial protocol,” Dr Thomas Duthy, Executive Director of Neurotech, said.
“It is certainly pleasing that under the supervision and care of Associate Professor Carolyn Ellaway at The Children's Hospital at Westmead that all patients and their families have elected to continue treatment with NTI164 for a period of one year. We eagerly await the clinical findings from this world-first cannabinoid drug therapy trial in Rett Syndrome over the coming weeks.”
Rett Syndrome is a rare genetic neurological and developmental disorder and is almost exclusively the result of a mutation(s) in the methyl CpG binding protein 2 (MECP2) gene located on the X chromosome, which is required for normal brain development and function.
Rett Syndrome occurs almost exclusively in girls, with incidence of one in 10,000 female live births. The prevalence is approximately 15,000 girls and women in the US and 350,000 globally. The market is estimated at over US$2 billion annually.