Clarity commences Cu-64/Cu-67 SAR-bisPSMA theranostic prostate cancer trial

SYDNEY,July 28,2021 -- Clarity Pharmaceuticals,a clinical stage radiopharmaceutical company focused on the treatment of serious disease,is pleased to announce that it has commenced its 64/67Cu SAR-bisPSMA theranostic clinical trial in patients with metastatic castrate resistant prostate cancer (mCRPC) in the US. Patient recruitment has commenced with the opening of the first clinical site at the Urology Cancer Center and GU Research Network in Omaha,Nebraska.

Clarity's Executive Chairman,Dr Alan Taylor,commented,"The prostate cancer market is a key focus for Clarity and we are very pleased to commence this clinical trial for men with mCRPC using our optimised theranostic PSMA products,64/67Cu SAR-bisPSMA. The exciting news about the commencement of the SECuRE trial (NCT04868604)[1] comes shortly after the initiation of our diagnostic 64Cu SAR-bisPSMA clinical trial called PROPELLER (NCT04839367)[2]. Clarity's SAR-bisPSMA products hold great promise of improving prostate cancer diagnosis and treatment and have the potential to provide multiple benefits in comparison to current products in the market."

The SECuRE trial is a Phase I/IIa theranostic trial for identification and treatment of PSMA-expressing mCRPC using Targeted Copper Theranostics (TCT). 64Cu SAR-bisPSMA is used for diagnosis and selection of patients and 67Cu SAR-bisPSMA for therapy. It is a multi-centre,single arm,dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this study is to determine the safety and efficacy of 67Cu-SAR-bisPSMA as a therapy.

Dr Taylor said: "We look forward to progressing both the SECuRE and PROPELLER trials in patients with prostate cancer to build on the compelling results from our therapeutic and diagnostic preclinical studies. There is a high unmet need for early detection and better treatment options for patients with prostate cancer,especially with mCRPC,for which the median life expectancy is less than three years. We believe that the TCT hold great promise for this patient population due to the logistical,manufacturing and treatment benefits associated with the optimised SAR-bisPSMA product and the "perfect pairing" of copper-64 (64Cu) and copper-67 (67Cu) radioisotopes. We look forward to progressing these trials and getting closer to achieving our ultimate goal of developing better treatments for 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 therapies based on its SAR Technology Platform for the treatment of cancer and other serious diseases in adults and children.

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 worldwide[3]. In 2021,the National Cancer Institute estimated 248,530 new cases of prostate cancer in the US and around 34,130 deaths from the disease[4]. Annually,there are around ~34,000 men in the US who are diagnosed with mCRCP[5],~90% of whom have tumours which express PSMA[6].

References

ClinicalTrials.gov Identifier: NCT04868604 https://clinicaltrials.gov/ct2/show/NCT04868604

ClinicalTrials.gov Identifier: NCT04839367https://clinicaltrials.gov/ct2/show/NCT04839367

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

American Cancer Society,https://cancerstatisticscenter.cancer.org/?_ga=2.79808020.284532473.1620009137-1916069442.1615761164#!/cancer-site/Prostate

D. A.Silver,I. Pellicer,W. R.Fair,W. D.Heston andC.Cordon-Cardo 1997. "Prostate-specific membrane antigen expression in normal and malignant human tissues." Clinical Cancer Research. vol. 3,81-85,January 1997

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