Program relevance: TLX591-CDx (68Ga-PSMA) for the imaging of prostate cancer with positron emission tomography (PET). Branded as illumetTM in the United States.
Synopsis: Cancer researchers at the Winship Cancer Institute, Emory University (Atlanta, USA) have been awarded a USD $3.4m (AUD 4.9m) grant by the National Institutes of Health (NIH) to compare Axumin®1 against 68Ga-PSMA in high-risk prostate cancer patients that will be receiving radiation therapy following prostatectomy. Telix is a technology partner and collaborator for the grant and is providing the PSMA PET imaging for the study. The study is a prospective, randomised, phase II study in 140 patients.
Key Points for Investors:
Winship is a National Cancer Institute (NCI)-designated comprehensive cancer centre and a thought leader in molecular imaging with positron emission tomography (PET).
Axumin® is currently approved in the US for imaging metastatic prostate cancer. Axumin® was developed at Emory University and so this is a particularly meaningful collaboration in terms of Key Opinion Leader (KOL) engagement.
This study builds on prior comparative experience between PSMA imaging and Axumin®, in which PSMA imaging has demonstrated detection superiority.
The novelty of this study is the application of advanced prostate imaging techniques to guide radiotherapy.
Telix has elected to support this study as part of ongoing collaborative clinical activity to explore future applications and additional indications for 68Ga-PSMA (illumetTM) imaging
About Winship Cancer Institute: https://winshipcancer.emory.edu/about-us/index.html
About the study: https://winshipcancer.emory.edu/about-us/newsroom/press- releases/2019/clinical-trial-to-enhance-post-prostatectomy-outcomes
Study overview video (YouTube): https://youtu.be/fiicHpVxNqA
Clinicaltrials.gov (NCT03762759): https://clinicaltrials.gov/ct2/show/NCT03762759
Telix Pharmaceuticals and Emory Winship Cancer Institute to Collaborate on Clinical Trial Using Advanced Imaging of Prostate Cancer for Radiotherapy
Melbourne (Australia) and Atlanta (USA) – 31 May 2019. Telix Pharmaceuticals Limited (ASX.TLX) (“Telix”, the “Company”), 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 utilise positron emission tomography (PET) imaging with FDA approved fluciclovine (Axumin®) or Telix’s investigational 68Ga-PSMA kit, marketed as illumetTM 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 randomises 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 illumetTM 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."
About Telix Pharmaceuticals Limited Telix Pharmaceuticals Limited (Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com.