Clinical-stage radiopharmaceutical company Clarity Pharmaceuticals (ASX:CU6) has imaged the first patient in its registrational Phase 3 64Cu-SAR-bisPSMA diagnostic trial in participants with biochemical recurrence (BCR) of prostate cancer.
The trial, AMPLIFY (NCT06970847) 1, is at XCancer in Omaha.
Urologic medical oncologist and CEO of XCancer, Dr Luke Nordquist, “We are thrilled to recruit the first participant in the AMPLIFY trial and to image them just over a week after study initiation. 64Cu-SAR-bisPSMA could become a best-in-class diagnostic prostate-specific membrane antigen (PSMA) agent, and we are honoured to be part of this registrational trial that intends to gather sufficient data for a New Drug Application (NDA) and a potential subsequent commercialisation of this next-generation product.
"We have already observed the potential benefits of 64Cu-SAR-bisPSMA based on data from earlier phase trials such as Clarity’s PROPELLER and COBRA studies and look forward to participating in the AMPLIFY trial, providing this optimised product to our patients in need of novel diagnostic solutions. The COBRA trial that laid the foundation for AMPLIFY in patients with BCR of prostate cancer showed that more lesions and more patients with a positive scan were identified on 64Cu-SAR-bisPSMA positron emission tomography (PET) compared to conventional scans and on next-day vs. same-day imaging. 64Cu-SAR-bisPSMA also allowed for the identification of lesions in the 2-mm range and was able to detect lesions at least 6 months earlier than the current standard-of-care (SOC) PSMA PET agents. The team at XCancer looks forward to further building on this evidence in the AMPLIFY trial as we progress towards our mutual goal of improving treatment outcomes for patients with cancer.”
Clarity’s executive chairperson, Dr Alan Taylor, said, “We are excited to have imaged the first patient in the AMPLIFY trial and look forward to further progressing recruitment and opening clinical sites across the United States (US) and Australia, providing access to 64Cu-SAR-bisPSMA in both countries as part of this trial. We have built a robust supply of copper-64 with a wide network of product manufacturers in preparation for our two Phase III trials, AMPLIFY in BCR and CLARIFY3 in pre-prostatectomy, and potential commercialisation.
"As such, we are ideally positioned to build on the clinical advantages of 64Cu-SAR-bisPSMA based on its higher lesion uptake and contrast, increased lesion detection rate compared to SOC imaging and flexible imaging schedule, enabled by its dual targeting (bisPSMA), proprietary chelator technology (sarcophagine, SAR) and copper-64 properties. We are also prepared to fully leverage the logistical and supply chain advantages associated with the optimal half-life of this isotope, in comparison to short-lived gallium-68 and fluorine-18, which allows 64Cu-SAR-bisPSMA to be made centrally in one location and shipped on-demand to any treatment facility in the country. This model enables better access and geographic distribution, meaning men with cancer could get an accurate and early diagnosis whether their location is a major city or regional area, as long as there is a PET camera on site.
“With prostate cancer prevalence increasing year after year, we look forward to overcoming limitations of the current-generation PSMA PET diagnostics, such as sensitivity and accessibility, making earlier and more accurate detection of recurrent disease a potential reality and bringing our optimised diagnostic to more men with this insidious disease around the world.”
