Sydney, Australia 10 August 2021 – Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, is pleased to announce that the first patient has been dosed in the 64Cu SAR-bisPSMA clinical trial in patients with confirmed prostate cancer.
Clarity’s Executive Chairman, Dr Alan Taylor, commented, “We are very excited to have treated our first patient in this clinical trial for men with confirmed prostate cancer using our optimised PSMA agent, 64Cu SAR-bisPSMA, at GenesisCare CTA Medical Clinic in Perth, Australia. We look forward to recruiting additional patients at all three of the clinical sites and generating data to confirm the compelling results from our preclinical studies.”
SAR-bisPSMA derives its name from the word “bis”, which reflects the novel approach of connecting two PSMA binding motifs to Clarity’s SAR chelator technology (instead of one) to increase tumour uptake and retention in cancerous tissues. Preclinical data confirms that both uptake and retention are higher for 64Cu SAR-bisPSMA than that of the single PSMA binding motif utilised by other radiopharmaceutical products on the market.
The PROPELLER trial is a Phase I Positron Emission Tomography (PET) imaging trial of participants with confirmed prostate cancer using 64Cu SAR-bisPSMA. It is a 30-patient multi-centre, blinded review, dose ranging, non-randomised study of 64Cu-SAR-bisPSMA administered to patients with confirmed prostate cancer prior to radical prostatectomy (NCT04839367)1. The aim of the PROPELLER trial is to determine the safety and tolerability of 64Cu SAR-bisPSMA in participants with untreated, confirmed prostate cancer and planned for radical prostatectomy, as well as compare 64Cu SAR-bisPSMA to 68Ga PSMA-11, the standard of care for prostate cancer imaging in Australia.
Dr Taylor said: “We look forward to further exploring the benefits of the Targeted Copper Theranostics (TCT) platform for patients with prostate cancer, one of the largest indications in oncology. With our 64/67Cu SAR-bisPSMA theranostic trial having commenced last week in the US (SECuRE trial (NCT04868604)2), we believe that Clarity is well positioned to leverage the logistical, manufacturing and treatment benefits associated with the optimised SAR-bisPSMA product and the “perfect pairing” of copper-64 and copper-67 to provide a large patient population with early, accurate and precise detection of prostate cancer and improve patient outcomes. These two trials, PROPELLER and SECuRE, will enable Clarity to get closer to achieving its ultimate goal of improving the treatment of children and adults with cancer.”
About Clarity
Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious disease. The Company is a leader in innovative radiopharmaceuticals, developing targeted copper theranostics based on its SAR Technology Platform for the treatment of cancer in children and adults.
www.claritypharmaceuticals.com
About Prostate Cancer
Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death worldwide3. The National Cancer Institute estimates in 2021 there will be 248,530 new cases of prostate cancer in the US and around 34,130 deaths from the disease4.
References
- ClinicalTrials.gov Identifier: NCT04839367 <https://clinicaltrials.gov/ct2/show/NCT04839367>
- ClinicalTrials.gov Identifier: NCT04868604 <https://clinicaltrials.gov/ct2/show/NCT04868604>
- Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries <https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660>
- American Cancer Society, Cancer Statistics Center, <https://cancerstatisticscenter.cancer.org/?_ga=2.79808020.284532473.1620009137-1916069442.1615761164#!/cancer-site/Prostate>
Media Contact
Dr Alan Taylor
Executive Chairman
+61 (0)413 871 165
ataylor@claritypharm.com
