Clarity Pharmaceuticals: Receives IND approval from FDA for phase 2 SAR-Bombesin imaging trial

Clarity Pharmaceuticals Receives IND approval from FDA for phase 2 SAR-Bombesin imaging trial

• Clarity Pharmaceuticals (CU6) receives approval from the US Food and Drug Administration (FDA) of its investigational new drug (IND)
• The approval will enable a Phase 2 imaging trial to detect prostate cancer in up to 50 prostate-specific membrane antigen (PSMA)-negative using its SAR-Bombesin product
• The primary objectives of the trial is to investigate the safety and tolerability of copper-64 SAR-Bombesin and in addition, its ability to correctly detect the recurrence of prostate cancer
• Further, the trial is developed in response to the strong demand from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents of conventional imaging
• Shares in Clarity end the day 2.11 per cent in the red to close at 46.5 cents