Imagion Biosystems (ASX:IBX) started manufacturing the MagSense HER2 imaging agent for its phase two clinical study, a requirement for filing an investigational new drug application with the US Food and Drug Administration, according to a Wednesday Australian bourse filing.
In the second phase of the clinical study, the company plans to optimize the dose of the imaging agent and the imaging protocol to establish the diagnostic performance.
The imaging agent is a candidate for use in the assessment of axillary nodal disease in HER2-positive breast cancer patients.
Manufacturing is expected to start in mid-April, and production is expected to be completed in June.
The firm's shares rose nearly 6% in recent trading on Wednesday.
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