Recruitment for the dosimetry phase of Clarity’s Cu-64/Cu-67 SAR-bisPSMA theranostic prostate cancer trial completed

The SECuRE study is a Phase I/IIa theranostic study for the identification and treatment of mCRPC expressing prostate-specific membrane antigen (PSMA) using TCT. 64Cu SAR-bisPSMA is used to visualize PSMA-expressing lesions and select candidates for subsequent 67Cu SAR-bisPSMA therapy. The initial dosimetry phase used 64Cu SAR-bisPSMA to determine the biodistribution and dosimetry of the products in humans. The SECuRE study is a multicenter, single-arm, dose-escalation study with a planned cohort expansion 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.

Clarity’s Executive Chairman, Dr Alan Taylor, commented: “We are very pleased to have completed recruitment for the initial dosimetry phase of the SECuRE trial in mCRPC quickly and successfully using our optimized next-generation PSMA agent. , SAR-bisPSMA, and look forward to We are excited to move quickly into the therapy phase with 67Cu SAR-bisPSMA at all seven clinical sites selected for this study in the US.

“The PET imaging data obtained so far in the SECuRE study looks promising and the images confirm our excellent preclinical results of high tumor targeting and retention, while seeing outgrowths in other tissues. We are excited about the comparison with the standard bone scan (the recommended modality for bone imaging in clinical trials according to the Prostate Cancer Clinical Trials Working Group 3), indicating that 64Cu SAR-bisPSMA can visualize bone involvement. This further supports the emerging evidence of increased sensitivity and specificity of PSMA PET tracers for detecting micrometastases compared to conventional imaging.With the recently updated US National Comprehensive Cancer Network Guidelines® now allowing the use of FDA-approved PSMA PET agents as an alternative to conventional imaging, we are really looking forward to this product quickly through clinical Letting go of trials with the added value of production, logistics and patient benefits at 64Cu.

“Our TCT platform uniquely uses the same chemical entity for both diagnosis and therapy, leading to high accuracy and high precision, and highlights the benefits of generating 64Cu imaging data from 1 hour to 72 hours after administration to assess the suitability of strongly believe that SAR-bisPSMA will be an important pillar in the next generation of radiopharmaceuticals, with both diagnostic and therapeutic blockbuster prostate cancer will provide significant benefits to both patients and clinicians compared to current products on the market.”

dr. Luke Nordquist, CEO, Urologic Medical Oncologist at the Urology Cancer Center and GU Research Network in Omaha, Nebraska, who treated patients in the initial dosimetry phase of the study, commented, “I am very impressed with the data from the initial dosimetry phase. and we look forward to moving the SECuRE study into the therapy phase and further validating the benefits of the 64Cu SAR-bisPSMA and 67Cu SAR-bisPSMA products for both clinicians and patients. the new PET agents rely on radionuclides with a very short half-life, such as 18F and 68Ga, which limits their availability and use.Having access to centrally manufactured PET imaging products with a more suitable half-life, such as 64Cu, will significantly improve patient care and addressing the current backlog of patients waiting for critical imaging scans.sis and treatment will have significant benefits for p patients with prostate cancer.”

Taylor said: “The future of radiopharmaceuticals is here, where patient care is not defined by the limited half-life of the isotope, but instead focuses on what is important to the patient, clinician and treating staff – safety, efficacy, access and The further expansion of radiopharmaceuticals into more indications, with increased use by a broad spectrum of clinicians, will depend on centralized, high-volume and simple delivery logistics of isotopes and ready-to-use radiopharmaceuticals, with a focus on long-term environmental impacts. Clarity’s ability to centrally produce and widely distribute large quantities of copper-based products, without long-lived radioactive waste products or dependence on nuclear reactors, will be an important factor in addressing major markets in a sustainable way. TCT platform and numerous TCT products quickly through clinical The trials of genera of compelling clinical data and closer to reaching our ultimate goal of developing better treatments for children and adults with cancer.”

This announcement has been approved for publication by the Executive Chairman.

About prostate cancer

Prostate cancer is the second most common cancer in men worldwide and the fifth leading cause of cancer death worldwide[2]. In 2021, the National Cancer Institute estimated 248,530 new cases of prostate cancer in the US and approximately 34,130 deaths from the disease[3]. Annually, there are approximately ~34,000 men in the US who are diagnosed with mCRCP. is being asked[4], of which ~90% have tumors expressing PSMA[5].


1. Identifier: NCT04868604
2. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries
3. American Cancer Society, Cancer Statistics Center,!/cancer-site/Prostate
4. American Cancer Society, Cancer Statistics Center,!/cancer-site/Prostate
5. DA Silver, I. Pellicer, WR Fair, WD Heston, and C. Cordon-Cardo 1997. “Prostate Specific Membrane Antigen Expression in Normal and Malignant Human Tissues.” Clinical cancer research. full. 3, 81-85, January 1997

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About Clarity Pharmaceuticals

Clarity is a clinical-stage radiopharmaceutical company focused on the treatment of serious diseases. The company is a leader in innovative radiopharmaceuticals and develops targeted copper theranostics based on its SAR technology platform for the treatment of cancer in children and adults.

SOURCE Clarity Pharmaceuticals

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