Therapy Areas
Clarity Pharmaceuticals receives positive FDA response for next-generation PSMA theranostic products Investigational New Drug application
5 May 2021 -

Clarity Pharmaceuticals, an Australia-based clinical stage radiopharmaceutical company, has received a response from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application, saying that the study for selection and treatment of Prostate-Specific Membrane Antigen (PSMA) positive prostate cancers using 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA can proceed, it was reported on Tuesday.

The SECuRE trial (Systemic Cu theranostics in prostate cancer) is a Phase I/IIa study intended for the identification and treatment of PSMA-expressing metastatic castrate resistant prostate cancer (mCRPC) that will be conducted in the United States (NCT04868604)[1]. It is a theranostic multi-centre, single arm, dose escalation study with a cohort expansion proposed for up to 44 subjects. The trial uses diagnostic Positron Emission Tomography imaging with 64Cu-SAR-bisPSMA for selection of patients suitable for therapy cycles with 67Cu-SAR-bis-PSMA.

Dr Alan Taylor, Clarity's executive chairman, was quoted as saying: "The FDA response suggests not only the importance of developing novel treatments for men with late-stage prostate cancer, whose prognosis is currently very poor, but also validates Clarity's copper pairing paradigm and the centralised manufacturing concept, which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications."