Imugene Limited (ASX: IMU) has received Human Research Ethics Committee (HREC) approval to begin a Stage 2 clinical trial of its immunotherapy candidate, HER-Vaxx in Australia.
The ethics approval confirms that the Company has completed the required pre-clinical safety as well as efficacy testing of HER-Vaxx mandatory to start its nextHERIZON clinical trial in Australia.
nextHERIZON is an open-label, multi-center, signal generating, Stage 2 clinical trial intended to evaluate the safety & effectiveness of HER-vaxx along with chemotherapy or pembrolizumab in patients with metastatic HER-2/neu over-expressing gastric or gastroesophageal junction adenocarcinomas who have earlier progressed on trastuzumab.
The Australian constituent of the Stage 2 trial will be done under Australia’s Clinical Trials Notification Scheme. IMU will inform the Therapeutic Goods Administration of HREC approval & complete local site initiation activities.
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