Clarity Pharmaceuticals (ASX: CU6) has announced the approval of its Investigational New Drug (IND) application by the US FDA to evaluate its SAR Bombesin product as an imaging agent in prostate cancer patients that are Prostate-Specific Membrane Antigen (PSMA)-negative.
Executive chairman Dr Alan Taylor said, “Receiving clearance from the FDA on the imaging trial with SAR-Bombesin is yet another significant milestone for Clarity. It shows our ability to develop cutting-edge theranostics from the lab, through preclinical studies and into clinical trials, with SAR-Bombesin being Clarity’s fourth IND across five products which are clear for investigation in the US.”
The company said the IND gives its clearance to proceed with a US-based Phase II 64Cu SAR-Bombesin Positron Emission Tomography (PET) imaging trial in participants with PSMA-negative BCR of prostate cancer following definitive therapy (such as surgery or radiation).
SABRE, which derives from 'Copper-64 SAR-Bombesin in Biochemical REcurrence of Prostate Cancer trial', is a multi-centre, 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.
The company said the SABRE trial builds on the promising clinical data from the pilot trial assessment of 64Cu SAR-Bombesin in breast cancer led by Professor Louise Emmett of St Vincent’s Hospital Sydney.
It said the trial was developed in response to the strong demand for this product from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents or conventional imaging (such as CT and/or MRI).
“We look forward to further progressing the development of SAR-Bombesin and hope it will provide a new and effective diagnostic option for prostate cancer patients. Building on the promising clinical and preclinical data acquired to date, we are also planning an IND submission for a theranostic trial in prostate cancer participants, using 67Cu SAR-Bombesin therapy paired with the imaging agent, 64Cu SAR-Bombesin. Combined with the clinical, environmental and logistical benefits enabled by the copper isotope pairing, SAR-Bombesin has potential to provide this large patient population with accurate and precise detection and treatment of prostate cancer. We anticipate the SABRE trial to commence shortly and the theranostic trial to commence in 2023,” added Dr Taylor.