Clarity receives US FDA clearance of IND Application for its next-generation PSMA theranostic products

SYDNEY, May 4, 2021 / PRNewswire / – Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company focused on the treatment of serious diseases, is pleased to announce that it has received a response from the U.S. Food and Drug Administration (FDA) to his research New Drug (IND) application that continues the study for the selection and treatment of prostate-specific membrane antigen (PSMA) -positive prostate cancers using 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA.

The SECuRE (Systemic Cu theranostics in prostate cancer) study is a phase I / IIa study for the identification and treatment of metastatic castration resistant prostate cancer expressing PSMA (mCRPC) to be conducted in the US (NCT04868604)[1]. It is a theranostic multicentre, single-arm, dose-escalation study with a cohort extension planned for up to 44 patients. The study uses diagnostic Positron Emission Tomography imaging with 64Cu-SAR-bisPSMA to select patients suitable for therapy cycles with 67Cu-SAR-bis-PSMA.

Prostate cancer is the second most common cancer in men and the fifth leading cause of death worldwide[2]. The American Cancer Society estimates there will be 248,530 new cases of prostate cancer in the U.S. by 2021 and about 34,130 deaths from the disease[3]. For metastatic prostate cancer, the 5-year relative survival rate is 30%, indicating a high unmet need for early detection and better treatment options for mCRPC. There are approximately ~ 34,000 men in the US annually who are diagnosed with mCRCP[3], ~ 90% of whom have tumors expressing PSMA[4].

While there are some new therapeutic radiopharmaceuticals for prostate cancer in late phase clinical trials, given the large patient population, the product supply for therapeutic radiopharmaceuticals is limiting as they depend on the production of therapeutic isotopes from a small number of nuclear reactors, with a reactor shutdowns often cause isotope shortages around the world.

Clarity’s SAR bisPSMA product uses two isotopes of copper, which do not have the same limitations:

The therapeutic product uses copper-67, which is produced on electron accelerators in the US, avoiding the problems commonly associated with isotope production in nuclear reactors. The diagnostic product uses copper-64, which is regularly produced in significant quantities on cyclotrons in the US, and has a half-life of 12.7 hours, avoiding the short half-life problems of other diagnostic isotopes. The diagnostic and therapeutic products can be centrally manufactured and shipped as a finished product directly to the treatment centers, eliminating the need for dedicated radiopharmacy facilities in treatment centers.

Dr. Alan Taylor, Clarity’s executive chairman, said of the IND approval: “The FDA response not only suggests the importance of developing new treatments for men with late stage prostate cancer, which are currently very poor prognosis. , but also confirms Clarity’s copper pairing paradigm and centralized manufacturing concept, which sets it apart from the competition’s products and enables product delivery to levels suitable for use in large patient indications. ”

“We are very excited to start the SECuRE trial in mCRCP patients and have engaged a group of key world-class prostate cancer thought leaders to support the development of 64 / 67Cu SAR-bisPSMA. Clarity’s Global Clinical Development Group has announced unparalleled experience in the commercialization of the only currently approved radiotherapeutic agent for prostate cancer The FDA response is a critical milestone in the development of SAR-bisPSMA theranostics and we look forward to continuing this study at some of the leading cancer centers in the US as part of our ultimate goal of developing better treatments for children and adults with cancer, ”said Dr. Taylor


National Institute of Health, US National Library of Medicine, World Cancer Research Fund, Prostate Cancer Statistics, cancer statistics American Cancer Society, Cancer Statistics Center,!/cancer-site/ Prostate 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

About clarity

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

SOURCE Clarity Pharmaceuticals

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