Clarity Pharmaceuticals begins phase II trial using SAR-Bombesin as prostate cancer diagnostic
SAR-Bombesin is a “highly targeted” wide-ranging cancer radiopharmaceutical, which can be paired with Copper-64 for diagnostic use and Copper-67 for therapy.
Clarity Pharmaceuticals (ASX: CU6) has begun a phase II diagnostic trial for patients with prostate cancer using its Copper-64 SAR-Bombesin product in imaging scans.
According to Clarity, SAR-Bombesin is a “highly targeted” wide-ranging cancer radiopharmaceutical.
It has “broad cancer application” and works by targeting the gastrin-releasing peptide receptor (GRPr), which is present in a range of cancer cells including prostate, breast and ovarian malignancies.
GRPr is found in 75-100% of prostate cancers.
SAR-Bombesin uses Clarity’s proprietary sarcophagine (SAR) technology, which holds copper isotopes “inside a cage-like structure” known as a chelator.
Clarity says that unlike other commercially available chelators, its SAR technology prevents copper leakage into the body.
As well as a diagnostic tool with Copper-64, Copper-67 can be paired in SAR-Bombesin for targeted therapy.
Prostate cancer trial
The phase II investigator initiated trial (IIT) that has just begun is evaluating the safety and diagnostic potential of SAR-Bombesin in imaging prostate specific membrane antigen (PSMA) negative prostate cancer sufferers.
In today’s announcement, Clarity revealed the first patients had been recruited and imaged for the trial.
Up to 30 patients will join the trial, which is being carried out at Sydney’s St Vincent’s Hospital under Prof Louise Emmett’s leadership.
“The SAR-Bombesin product is a promising target for a large patient population with a high unmet need and few treatments available to them,” Prof Emmett explained.
“We are excited to now make the product available to a larger pool of patients under clinical trial conditions.”
Prof Emmett noted that SAR-Bombesin has already shown “very promising data” through a previous PSMA study under Australia’s Therapeutic Goods Administration’s Special Access Scheme as well a pilot diagnostic study investigating SAR-Bombesin in breast cancer patients.
In the current trial, two different groups of men will be assessed. The first group will involve patients with suspected biochemical recurrence of their prostate cancer with negative PSMA position emission tomography (PET) imaging scans or low PSMA expression.
The second group will include patients with metastatic castrate resistant prostate cancer who are not eligible for PSMA therapy.
Commenting on the study, Clarity executive chairman Dr Alan Taylor said he believes SAR-Bombesin has the potential to provide “accurate and precise detection and treatment of cancers” across large patient populations.
Radiopharmaceuticals expert joins Clarity
Earlier this week, Clarity revealed Dr Jeffrey Norenberg had been appointed as the company’s chief scientific officer.
Dr Norenberg has more than three decades’ experience in radiopharmaceuticals including a 27-year tenure as a Prof Emeritus of Pharmacy and Anesthesiology and Critical Care Medicine and director of Radiopharmaceutical Sciences at the University of New Mexico’s Health Sciences Centre.
Dr Taylor said Dr Norenberg brought “highly relevant and valuable” expertise to Clarity as it develops and commercialises its next generation radiopharmaceuticals.
China patent
Clarity also reported it had secured a patent in China covering its SAR-bisPSMA targeting agent.
The patent follows ones previously granted for SAR-bisPSMA in the US, Australia and Mexico, with others pending in Europe and Japan.
“This milestone continues Clarity’s strong emphasis on intellectual property (IP) protection covering the SAR Technology platform and each new product that stems from it,” Dr Taylor said.