Imugene Ltd (ASX:IMU) has received approval from the University of Hong Kong Institutional Review Board for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy for gastric cancer.
HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.
Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.
The approval from the Ethics Committee positions Imugene to enrol patients for the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.
The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.
This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.
The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.
For Hong Kong there were around 1,100 new gastric cancer cases last year, representing a market for any product that is commercialised from the studies.
Imugene held $2.4 million in cash as at 31 March 2016.
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