IND approval from the US FDA for Phase II SAR-Bombesin imaging trial in prostate cancer
SYDNEY, June 6, 2022 /PRNewswire/ -- Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address growing medical needs in oncology, announces the approval of its Investigational New Drug (IND) application by the United States Food and Drug Administration (US FDA) to evaluate its SAR-Bombesin product as an imaging agent in prostate cancer patients that are Prostate-Specific Membrane Antigen (PSMA)-negative.
- Clarity's Executive Chairman, Dr Alan Taylor, commented,"Receiving clearance from the FDA on the imaging trial with SAR-Bombesin is yet another significant milestone for Clarity.
- SABRE, which derives from "Copper-64 SAR-Bombesin in Biochemical REcurrence of Prostate Cancer trial", is a multi-center, single arm, non-randomised, open-label trial in up to 50 PSMA-negative patients with known or suspected prostate cancer.
- The primary objectives of the trial are to investigate the safety and tolerability of 64Cu SAR-Bombesin, as well as its ability to correctly detect the recurrence of prostate cancer.
- Given the prostate cancer indication is one of the largest in oncology, there is a significant unmet medical need in this segment.