Friday, May 31, 2019
Telix Pharmaceuticals Limited, a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR) has today announced a prostate cancer imaging clinical collaboration with Winship Cancer Institute of Emory University. The trial is led by Winship radiation oncologist Ashesh Jani, MD, and Emory radiologist and nuclear medicine physician David Schuster, MD.
The collaboration, funded by a USD $3.4m (AUD $4.9m) grant from the National Institutes of Health (NIH), will utilize positron emission tomography (PET) imaging with FDA approved fluciclovine (Axumin®) or Telix’s investigational 68Ga-PSMA kit, marketed as illumet™ in the United States. The Phase II study (NCT03762759) will prospectively evaluate 140 prostate cancer patients who are eligible for radiation therapy post-prostatectomy. The trial randomizes the two different imaging techniques with the goal of determining the degree to which either imaging approach guides radiotherapy decisions, and whether there are improvements in patient outcome.
Director of the Division of Nuclear Medicine and Molecular Imaging and Georgia Research Alliance Distinguished Cancer Scientist, Dr. David Schuster noted, “We have worked very closely with Telix to get this study up and running with the illumet™ 68Ga-PSMA kit, including referencing the company’s FDA Drug Master File (DMF) in our Investigational New Drug (IND) application. The ease of use of the Telix product has made nuclear pharmacy validation straightforward and we are pleased to be collaborating with the Company to complete this study.” Dr. Schuster also noted, “This trial involves many innovative components including the first use of PSMA PET in Georgia and continues Emory’s tradition of innovation including the development and first use of fluciclovine for prostate cancer imaging.”
Telix Pharmaceuticals co-founder and CEO, Dr. Christian Behrenbruch stated, “We are very excited to be collaborating with Dr. Schuster and Dr. Jani, the co-principal investigators (PIs) on the study. This is an excellent study, both in its comparative scope between Axumin® and PSMA imaging, but also as a robust, prospective evaluation of how advanced prostate imaging has the potential to impact the application of radiotherapy techniques. It is precisely these kinds of prospective studies with PSMA imaging that are needed to gain the confidence of the oncology community.”
