BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced that the first patient has been dosed in its Phase 3 REVELATE clinical trial of 18F-fluciclovine, a positron emission tomography (PET) imaging radiopharmaceutical being studied for potential use in detecting recurrent brain metastases. The REVELATE study is a Phase 3, multi-center, single-arm imaging study being conducted in the United States. Its purpose is to assess the diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases in patients previously treated with radiation therapy. The first patient dosed in the study was at Yale University, New Haven, Conn., under the auspices of Dr. Mariam Aboian, Assistant Professor of Radiology.
Note: 18F-fluciclovine, under the tradename Axumin® (fluciclovine F 18) injection, is an FDA-approved and commercially available molecular imaging radiopharmaceutical for use in PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. The safety and efficacy of 18F-fluciclovine PET imaging for the detection of recurrent brain metastases has not been established.
Blue Earth Diagnostics has two clinical studies underway to investigate the use of 18F-fluciclovine PET in the detection of recurrent brain metastases. The Phase 2 PURSUE trial is designed to establish image interpretation criteria for 18F-fluciclovine PET in detecting recurrent brain metastases. REVELATE is a Phase 3 study designed to evaluate its diagnostic performance in the detection of recurrent brain metastases in patients previously treated with radiation therapy. Further information about these trials, including a current list of clinical trial sites, can be found on www.clinicaltrials.gov (PURSUE, NCT04410367; REVELATE, NCT04410133).
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"The mission of Blue Earth Diagnostics is to develop novel PET radiopharmaceuticals to address unmet medical needs and inform the management and care of patients with cancer. With these two clinical trials now underway, we are hopeful that our efforts may help patients with recurrent metastatic brain cancer," said Jonathan Allis, D. Phil., Executive Chairman of Blue Earth Diagnostics. "Blue Earth Diagnostics' initial focus for 18F-fluciclovine has been on the successful development and commercialization of Axumin in the United States and Europe for the detection and localization of recurrent prostate cancer, where it has become widely adopted as the standard of care and commercially administered to more than 110,000 U.S. patients. Broadening our 18F-fluciclovine franchise into neuro-oncology is part of our overall growth strategy for the company. This rapid advancement of 18F-fluciclovine into Phase 3 clinical development marks a significant milestone for Blue Earth Diagnostics and is testimony to the proven expertise of the team."