BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, today announced results from early clinical experience in Germany with positron emission tomography/computed tomography (PET/CT) imaging using rhPSMA-7.3 (18F), a radiohybrid Prostate Specific Membrane Antigen-targeted compound. The results were presented by the Technical University of Munich (TUM) in an oral presentation at the American Urological Association's AUA2020 Virtual Meeting on May 15, 2020. Results of the retrospective analysis of 56 patients with intermediate or high-risk prostate cancer indicated that rhPSMA-7.3 (18F) PET/CT demonstrated a patient-level sensitivity of 81%, specificity of 88% and diagnostic accuracy of 86%, when on-site image interpretations were compared to histopathological findings.
Blue Earth Diagnostics is conducting two Phase 3 clinical trials of rhPSMA-7.3 (18F) PET imaging. The LIGHTHOUSE study (NCT04186819) will examine the potential use of rhPSMA-7.3 (18F) in newly diagnosed prostate cancer, and the SPOTLIGHT study (NCT04186845) is focused on its potential use in biochemical recurrent prostate cancer. Results from the early clinical experience by TUM, including with rhPSMA-7.3 (18F) PET, were included Blue Earth Diagnostics' Investigational New Drug (IND) submission.
"We are very pleased that TUM is able to share the results of this early clinical experience with the prestigious urology community through the Virtual Science platform at AUA2020," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Blue Earth Diagnostics has rapidly advanced our rhPSMA-7.3 (18F) research program since acquiring exclusive rights to theranostic rhPSMA technology in 2018, in line with our strategy to expand and advance a world-leading prostate cancer radiopharmaceutical portfolio. Both rhPSMA-7.3 (18F) and approved, commercially available Axumin® (fluciclovine F 18) have unique and complementary mechanisms of action, and we believe that each may ultimately allow physicians and their patients flexibility in selecting the diagnostic agent most appropriate to each specific clinical situation."
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"The ability to effectively stage primary prostate cancer is important in determining appropriate management for these patients," said Tobias Maurer, MD, of the Martini-Klinik and Department of Urology, University of Hamburg-Eppendorf, Germany (previously in the Department of Urology at TUM), who presented the results at AUA2020. "This retrospective analysis is the first report investigating the potential efficacy of the single isomer product rhPSMA-7.3 (18F), in PET imaging for primary lymph node staging in patients with intermediate and high-risk prostate cancer. Our study results indicated that rhPSMA-7.3 (18F) PET demonstrated 86% accuracy in men with primary prostate cancer. These preliminary data are encouraging and we are pleased that further research is ongoing."