10 September 2020
Release date 8 September 2020
Australian clinical-stage drug development company Noxopharm Limited (ASX:NOX) is pleased to announce that after a rigorous global search, the clinical research organisation (CRO), Parexel® Biotech, has been appointed to manage the Company’s Phase 2 DARRT-2 clinical study.
This marks a major commitment by the Company in its aim of seeing Veyonda® eventually come to market as a final line of treatment of end-stage cancer, with the DARRT program focused on prostate cancer in the first instance.
The clinical objective with Veyonda® is to deliver a form of immuno-oncology therapy considerably better tolerated, more accessible, more cost-effective and more broadly active than current forms of immuno-oncology therapy.
DARRT (Direct and Abscopal Response to RadioTherapy) is a novel form of immuno-oncology based on the ability of Veyonda® to convert tumours from COLD (lacking immune function) to HOT (possessing immune function). DARRT relies on a low dose of radiotherapy to provide the trigger for immune activation, with the role of Veyonda® being to amplify and spread that response to tumours throughout the body.
The DARRT-2 study is a multi-national Phase 2 control-arm study in approximately 200 men with end-stage metastatic castrate-resistant prostate cancer.
Hospital and clinician recruitment will now commence, with all regulatory and ethical approvals to follow. Patient recruitment is anticipated to commence early in the New Year. The trial has a number of in-built milestones that will be reported on over the course of the study.
What the Company is hoping to show is that a combination of Veyonda® and low-dose radiotherapy delivered as standard external beam radiotherapy is well tolerated and provides a more meaningful anti-cancer response (less disease progression, less pain, better quality of life) compared to standard palliative care.
Parexel Biotech will administer and implement the study. Parexel Biotech is a division of Parexel, a global leader in biopharmaceutical and CRO services. With more than 20,000 employees in 100 countries around the world, Parexel Biotech is ideally situated to commence the administration and implementation of the DARRT-2 study.