NEW YORK – The US Food and Drug Administration on Tuesday accepted Clarity Pharmaceuticals' investigational new drug application for its theranostic product pair 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for the treatment of PSMA-positive prostate cancer.
64Cu-SAR-bisPSMA is a radiopharmaceutical diagnostic and 67Cu-SAR-bisPSMA is a radiopharmaceutical therapy to treat prostate cancer. The drugs were developed with Clarity's SAR technology platform, which pairs copper isotopes to both diagnose and treat cancers. These two products have identical molecules and biochemistry with the only difference being the copper isotopes used in the diagnostic, Cu-64, and in the radiopharmaceutical, Cu-67.
Clarity will study the diagnostic and radiopharmaceutical in the Phase I/IIa SECuRE trial and evaluate their ability to identify and treat PSMA-expressing, metastatic castration-resistant prostate cancer. The single-arm study will enroll up for 44 patients after determining dosage.
Participants will receive one to three 200 MBq administrations of 64Cu-SAR-bisPSMA and up to two administrations of 67Cu-SAR-bisPSMA in the trial. Researchers will measure patients' prostate-specific antigen (PSA) response and radiographic response.
"The FDA response [on the IND] 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 centralized manufacturing concept, which differentiates it from the competitor products and enables product supply to the levels suitable for use in large patient indications," Clarity's Executive Chairman Alan Taylor said in a statement.
Sydney-based Clarity is also developing theranostic products using its SAR platform for neuroblastoma, neuroendocrine tumors, and breast cancer.