FPM clinical trial underway at Peter Mac

The CRCBID-sponsored clinical trial into the use of fluoro propyl methionine (FPM) has now studied four patients at Peter Mac.  

Approval for the phase 0/1 trial to proceed was given by the Peter Mac Ethics Committee in August 2011, following a first time in human (FTIH) review of the tracer’s manufacturing process.

The research is focusing on FPM’s potential as an imaging agent in a phase 0/1 trial that is designed to prove safety in humans, but that will also assess biodistribution and explore the tumour targeting potential of the novel radoiolabelled amino acid.

“This is the second FTIH trial that has been successfully developed and conducted under the auspices of CRCBID,” says Dr Rob Ware, CRCBID’s Executive Director, Clinical Business.

“Skills gained implementing the phase 0/1 clinical trial of the melanoma tracer MEL050 at the end of last year and earlier this year significantly informed our processes and procedures when we were preparing for the FPM trial.  We now have a considerable body of expertise to support these activities.”

10 patients are scheduled to take part in the FPM clinical trial, with results expected to be available by June 2012.

 

FPM_No_1_Scan_image_courtesy_Peter_Mac

FPM PET/CT scan showing increased retention of tracer in right and left lung tumours as well as in an unsuspected brain metastasis. Image courtesy Peter Mac