On November 21, 2022 Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, reported presentations on investigational rhPSMA compounds and Axumin (fluciclovine F 18) at the upcoming 23rd Annual Scientific Meeting in Urologic Oncology (SUO), to be held in San Diego, Calif., from November 30 to December 2, 2022 (Press release, Blue Earth Diagnostics, NOV 21, 2022, View Source [SID1234624301]). They include the first presentation of key results from Blue Earth Diagnostics’ completed Phase 3 LIGHTHOUSE trial (NCT04186819) investigating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer. 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. An rhPSMA presentation from Blue Earth Diagnostics’ sister company, Blue Earth Therapeutics, will report on its ongoing Phase 1/2 trial investigating the use of 177Lu-rhPSMA-10.1 for treatment in metastatic castrate-resistant prostate cancer. In addition, a further presentation will report findings from experiments designed to better understand PSMA regulation in castrate-resistant and neuroendocrine prostate cancer and the potential role of 18F-fluciclovine PET imaging when these tumors have low PSMA expression.
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Details of selected presentations by Blue Earth Diagnostics and its collaborators are listed below.
NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment. Currently, rhPSMA compounds are investigational and have not received regulatory approval.
HIGHLIGHTED SCIENTIFIC PRESENTATIONS
SUO has designed this year’s meeting to feature all presentations in digital poster format, presented in scheduled blocks and available in the online poster gallery.
Blue Earth Diagnostics invites participants at the SUO 23rd Annual Meeting to attend the presentations above and to learn more about the company at its Medical Affairs educational booth. For session details and scientific presentation listings, please see the SUO online program here.
About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)
rhPSMA compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: ("SPOTLIGHT," NCT04186845), in men with recurrent disease and ("LIGHTHOUSE," NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.
Indication and Important Safety Information About Axumin
INDICATION
Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.
IMPORTANT SAFETY INFORMATION
Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.