Telix and Oncidium foundation have announced positive results from the NOBLE Registry study regarding the use of TLX599-CDx (99mTc-iPSMA), a prostate-specific membrane antigen (PSMA) single photon emission computed tomography (SPECT) imaging agent, for prostate cancer imaging.
The findings were published in the European Journal of Nuclear Medicine and Molecular Imaging (EJNMMI) Reports.
TLX599-CDx is a prostate cancer imaging agent targeting PSMA, using 99m-technetium (99mTc)-based SPECT technology.
The publication reported initial results from a study of 40 patients across six countries. These patients received TLX599-CDx, followed by planar and SPECT imaging.
The study found a management change in 17 patients (42.5%) due to SPECT-based PSMA imaging. No adverse events were reported.
Based on the results, the study authors concluded that technetium-based imaging is a promising option for identifying PSMA-positive prostate cancer on SPECT. This method could improve access to PSMA imaging worldwide, addressing an unmet need for prostate cancer patients who lack easy access to PET imaging.
Oncidium foundation CEO Rebecca Lo bue said: “PSMA-PET imaging is today widely used in many countries worldwide, helping to extend life and improve treatment outcomes for men with prostate cancer through earlier diagnosis and better disease management.”
The NOBLE Registry is a global real-world evidence study, which aims to improve access to advanced imaging for prostate cancer patients. It is a collaboration between the Oncidium foundation, Telix, and clinical partners.
Oncidium foundation provides oncology expertise and sponsors the research, while Telix contributes intellectual property and partnered clinical and operational support. The study is supported by an international network of principal investigators (PIs) who collect patient data.
This data will aid the development of TLX599-CDx.
According to Telix, SPECT cameras are being evaluated for prostate cancer imaging because they are more widely available than PET/CT scanners.
99mTc, the radionuclide used with SPECT, has a well-established supply chain and can be produced using a bench-top generator, the Australian biotechnology firm said.
Telix group chief medical officer David Cade said: “As established leaders in PSMA imaging, Telix is committed to exploring multiple avenues to help men with prostate cancer get the diagnoses and treatments they need.”
Telix and the Oncidium foundation plan follow-up clinical activities for NOBLE Registry. This may involve collaboration with Rhine Pharma on expanded access or compassionate use programmes.
In November last year, Telix and Grand Pharmaceutical Group announced the dosing of the first patient in the Phase 3 ZIRCON-CP trial of TLX250-CDx for kidney cancer imaging in Chinese patients.
