Nuclear medicine

BURLINGTON, Mass. & OXFORD, England (BUSINESS WIRE)- May 6, 2019- Blue Earth Diagnostics, a molecular imaging diagnostics company; today announced results from early clinical experience in Germany with positron emission tomography/computed tomography (PET/CT) imaging using a lead radiohybrid Prostate Specific Membrane Antigen-targeted compound ( 18 F-rhPSMA-7) by the Technical University of Munich (TUM) in two presentations at AUA2019.

Early clinical experience

Blue Earth Diagnostics acquired exclusive rights to a broad family of rhPSMA agents in 2018. In an oral presentation; results of a retrospective analysis of 58 patients with high risk primary prostate cancer ; indicated that 18 F-rhPSMA-7 PET/CT demonstrated sensitivity of 72% (13/18); specificity of 93% (37/40) and diagnostic accuracy 86% (50/58); when compared to histopathological findings.

A poster presentation described results from another retrospective analysis of 261 patients with biochemically recurrent prostate cancer in which 18 F-rhPSMA-7 PET/CT demonstrated; therefore a detection rate of 81% (211/261) at a median PSA level of 0.96 ng/mL. Because These retrospective analyses were presented at the American Urological Association’s 2019 Annual Meeting; AUA2019, May 3-6, 2019 in Chicago, Ill.

An investigational agent

NOTE: this early clinical experience with 18 F-rhPSMA-7 by TUM in Germany; consistent with the German Medicinal Products Act 13 (2b); reflects use of an investigational agent for which safety and efficacy have not been established by the U.S. Food and Drug Administration. Because “We are very pleased that TUM is able to share the results of this initial clinical experience with the prestigious urology community at AUA2019;” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics.

“Blue Earth Diagnostics acquired rhPSMA last year as part of our mission to develop and commercialize innovative PET imaging agents for cancer. rhPSMA is a strategic expansion of our technologically advanced imaging portfolio; and a complement to approved, commercially available Axumin (fluciclovine F 18).

We believe that both agents may ultimately provide physicians and their patients living with recurrent prostate cancer the ability to select the diagnostic agent most ; because appropriate to each specific clinical situation. We are currently progressing development of a lead 18 F-rhPSMA imaging candidate and collaborating with Scintomics to identify optimized therapeutic candidates for future development.”

Ultimately provide physicians

“Effective staging of primary prostate cancer and determining the extent and location of recurrent disease are important elements in determining appropriate management of 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 AUA2019.
“The retrospective analyses of 18 F-rhPSMA-7 PET/CT demonstrated an accuracy of 86% (50/58) in men with primary prostate cancer and a detection rate of 81% (211/261); therefore in men with biochemical recurrence; at a median PSA level of 0.96 ng/mL. These preliminary data are encouraging and support further research with rhPSMA.”