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Zelda Therapeutics receives approval for US autism study

The approval received is the equivalent to human research ethics approval in Australia.
concept of medicinal cannabis with leaf and tablets
This study can lay the ground work for a potential future clinical trial

Zelda Therapeutics Ltd (ASX:ZLD) has received Institutional Review Board (IRB) approval for its autism project, to be conducted at the Children’s Hospital of Philadelphia (CHOP) in the US.

The study will monitor child patients already being treated with medicinal cannabis formulations.

This initial study will lay the groundwork for a possible future clinical trial.

READ: Zelda Therapeutics and Children's Hospital of Philadelphia to study the pharmacology of cannabinoids

Zelda’s executive chairman Harry Karelis said “We are very excited to be formally commencing this study in the US working alongside CHOP.

“The high calibre of CHOP researchers and clinicians coupled with access to extensive infrastructure positions this study to be one of the first formal, robust studies of its type conducted to date.

“Positive results will allow Zelda to potentially expand into a formal clinical trial to study the efficacy of standardised, high-quality medicines.

“This study is being conducted in parallel with our pending clinical trial in Chile leveraging the observational data generated in 2017.”

Results expected within six months

This study will utilise CHOP’s extensive research infrastructure.

It will also capture a number of key efficacy and safety measures including bioanalytical studies.

The ultimate goal is to identify cannabinoid-based compounds that may demonstrate efficacy in the treatment of paediatric autism.

Preliminary results expected within six months.

READ: Zelda Therapeutics expands pancreatic cancer research with Curtin University

In early March, Zelda outlined that it would expand its research program with Curtin University testing cannabinoid extracts to potentially treat pancreatic cancer.

New research activities were to investigate the effect of a range of Zelda’s formulations with a focus on animals.

Results from these studies are expected to generate highly relevant data for potential future human clinical trials.

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