FDA Grants IND Approval for Prostate Cancer Clinical Trial

Clarity Pharmaceuticals recently announced its Investigational New Drug (IND) approval from the FDA to test theranostic SAR-Bombesin for prostate cancer. Prostate cancer is the fifth leading cause of cancer-related deaths in the world. In men, it is the second most common cancer diagnosis. According to the NCI, each year, there are approximately 268,490 cases and 34,500 deaths associated with prostate cancer in the United States.

SAR-Bombesin is a radiopharmaceutical that targets receptors on the cell surface in different cancers. According to the press release, gastrin-releasing peptide receptors (GRPr) are found in 75–100% of prostate cancers.

SAR-Bombesin is multipronged. The SAR component, also called sarcophagine, holds copper isotopes inside a chelator, preventing the copper from leaking into the body. In the statement, the company notes, “SAR-Bombesin is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.”

The study will be called COMBAT, short for copper-67 SAR Bombesin in metastatic castrate-resistant prostate cancer. The study will be a dose escalation study with cohort expansion.

In the press release, Clarity's Executive Chairman, Alan Taylor, commented, "We look forward to further progressing the development of SAR-Bombesin as a theranostic under this trial, as well as a stand-alone diagnostic agent under the SABRE and BOP clinical trials that are currently progressing in the US and Australia, respectively.”

“The diagnostic SAR-Bombesin product has already shown utility in improving the management of the disease for PSMA-negative prostate cancer patients, and given the mounting clinical and preclinical data to date, we believe that it has the potential to provide this large patient population with more accurate and precise detection and treatment of disease. SAR-Bombesin is a pan-cancer product, and the open IND offers exciting opportunities for exploring new theranostic indications with this versatile product as Clarity pursues our ultimate goal of improving treatment outcomes for children and adults with cancer," he continued.

Overall, having an additional tool to treat prostate cancer could be beneficial for patients who have not had success with earlier treatment. Considering the prevalence of prostate cancer, providers may take comfort in the availability of treatment methods. As this treatment goes through the FDA approval process, the FDA and providers will watch closely to monitor progress and outcomes.