- Imugene (IMU) receives Human Research Ethics Committee (HREC) approval to commence a phase one clinical trial of its VAXINIA drug in Australia
- The approval confirms the company has completed all necessary pre-clinical safety and efficacy testing of VAXINIA ahead of conducting human trials
- The Australian component of the trial will be conducted under the clinical trials notification (CTN) scheme
- The company will now notify the Therapeutic Goods Administration (TGA) of its HREC approval and complete local site initiation activities
- Shares in Imugene were up 6.25 per cent, trading at 17 cents at 11:00am AEDT
Imugene (IMU) has received approval to commence a phase one clinical trial of its oncolytic virotherapy candidate, VAXINIA in Australia.
The approval came from the from the Human Research Ethics Committee (HREC), and gives the green light for the company to progress towards commencing human clinical trials in Australia.
The sign off from HREC confirms all necessary pre-clinical safety and efficacy testing of VAXINIA has been completed.
The Australian component of the phase one trial will be conducted under the clinical trials notification (CTN) scheme.
This means the company will notify the Therapeutic Goods Administration (TGA) of HREC approval and complete local site initiation activities.
Managing Director and CEO Leslie Chong said the start of the company’s Australian study is a significant milestone for Imugene and clinicians treating Australians faced with the challenge of advanced solid tumour cancers.
“Accomplishing this goal speaks to the perseverance and dedication of Imugene’s clinical and research team as we continue to build on our clinical and commercial potential,” she said.
“In addition to the positive preclinical results, we’re incredibly eager to unlock the potential of VAXINIA and the oncolytic virotherapy platform for Australians inflicted with cancer.”
The first hospital to receive ethics approval is Tasman Oncology Research, a comprehensive cancer hospital located in South Australia.
Additional clinical sites will later be opened in Australia.
Shares in Imugene were up 6.25 per cent, trading at 17 cents at 11:00 am AEDT.