NEW YORK – Blue Earth Diagnostics on Wednesday said it would share clinical data from a Phase III trial of its prostate-specific membrane antigen (PSMA)-targeted, injectable PET imaging agent Posluma (flotufolastat F 18) in newly diagnosed prostate cancer patients with Siemens Healthineers.
Blue Earth Diagnostics is sharing data from the completed LIGHTHOUSE trial in which it evaluated the safety and diagnostic performance of Posluma PET imaging in men with newly diagnosed, unfavorable, intermediate-risk, high-risk, or very high-risk prostate cancer. Siemens Healthineers will use the clinical and imaging data to improve the artificial intelligence and analytics algorithms that its PET/CT imaging software applies to quantify and interpret prostate cancer images.
"We believe that the LIGHTHOUSE trial data will be enormously helpful in tailoring our AI technology to support the quantification and clinical interpretation of Posluma PET/CT images," Bruce Spottiswoode, director of clinical applications research at Siemens Healthineers, said in a statement. "The neural networks we are using have been shown to learn radiotracer-specific PET uptake, and we expect them to more efficiently identify clinically relevant features in 18F-flotufolastat images."
Blue Earth Diagnostics CEO David Gauden added in a statement that the firm also plans to make analytical data available from the Phase III SPOTLIGHT trial, which evaluated Posluma PET imaging to identify suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA).
The US Food and Drug Administration approved Posluma last year for detecting prostate cancer metastases based on data from the LIGHTHOUSE and SPOTLIGHT trials. In October, Blue Earth Diagnostics partnered with Sinotau Pharmaceutical Group to provide regulatory and technology support that could bolster Posluma's approval in China.