Blue Earth Diagnostics Highlights Presentations on POSLUMA® (Flotufolastat F 18), Axumin® (Fluciclovine F 18) and Investigational 18F-Flotufolastat/18F-rhPSMA-7 at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting
2024-05-29 · Blue Earth Diagnostics · original blueearthdiagnostics.com ↗
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Oncology: Cli SLUMA® (Flo ‐rhPSMA‐7 at MMI) Annual – Blue Earth D ation of innov tions by its co Meeting, to be PSMA‐7.3) is a mbrane antige e candidates f e‐specific ant ed prostate c tant scientific with the imag Earth Diagno ffects of urina by Dr. Isabel R tween 18F‐flot Lawal will dis ut the diureti Mallak of Ore of the use of nical experien th Diagnostics nces with an i A. tat and 18F‐rh n the evaluat /CT: Interim a n, Departmen inical Therapy tufolastat F 1 t Upcoming S Meeting Diagnostics, a vative PET ollaborators a e held June 8 t approved and en (PSMA) po for initial def igen (PSA) lev cancer recurre c information ging commun stics. “Two p ary bladder a Rauscher of th tufolastat an scuss interim ic furosemide egon Health a f Axumin in P nce with 18F‐r s collaborato investigationa hPSMA‐7 tion of bioche analysis of an nt of Radiolog y & Diagnosis 18), Axumin® Society of Nuc a Bracco comp at the Society to 11, 2024, i d indicated fo ositive lesions initive therap vel. Axumin® ence based o n about POSLU nity at SNMM resentations activity on ima he Technical d 68Ga‐PSMA results from e in patients w and Science SMA/PET‐ rhPSMA‐7 and rs are listed al agent for w emical recurr n ongoing gy and Imagin s 1 ® clear pany of in or s in py or is n UMA, MI,” aging ‐11 in a with d 18F‐ which rence ng 2 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241368 DATE: Sunday, June 9, 2024 Title: *Evaluation of qualitative and quantitative PET parameters in primary prostate cancer patients: double‐match comparison of 18F‐flotufolastat and 68Ga‐PSMA‐11‐PET Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241424 DATE: Saturday, June 8, 2024 Title: *18F‐rhPSMA‐7 and 18F‐flotufolastat PET‐guided salvage radiotherapy in recurrent prostate cancer Presenter: Isabel Rauscher, Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Department of Nuclear Medicine, Markt Schwaben, Germany Session Title: Prostate Cancer: Focus on Imaging Session Type: Oral presentation Session Time: 3:30 – 4:45 PM ET Presentation: 3:35 – 3:45 PM ET Abstract ID.: 241112 Axumin (fluciclovine F 18) DATE: Sunday, June 9, 2024 Title: Role of 18F‐fluciclovine PET/CT in patients with biochemical recurrence of prostate cancer and a negative PSMA PET/CT: interim results from a prospective trial Presenter: Nadine Mallak, MD, Associate Professor, Department of Diagnostic Radiology | Molecular Imaging & Therapy, Body Imaging Director, PET/MRI, Clinical, Oregon Health and Science University, Portland, Ore. Session Title: MTA05 POPs/Meet the Author: Oncology: Clinical Therapy & Diagnosis 1 Session Type: Poster presentation Session Time: 5:00 – 6:15 PM ET Abstract ID.: 241835 Blue Earth Diagnostics invites participants at the 2024 SNMMI Annual Meeting to attend the presentations above and to visit the Company at Exhibit Booth 1639. The Company is hosting a Satellite Symposium, “Let’s Talk about POSLUMA®,” which will discuss the most recent innovations in PSMA‐PET imaging for prostate cancer. It will feature invited speakers Sean Collins, MD, PhD, Professor, Georgetown University Hospital, and Elizabeth Hawk, MD, PhD, DABNM DABR, University of California San Diego, and be moderated by Todd Cohen, MD, VP of Medical Affairs, Blue Earth Diagnostics, Inc. The symposium will be held on Sunday, June 9, 2024, from 11:15 AM – 12:15 PM ET in the Toronto Convention Center, Room 701A, South Building – 700 Level. Blue Earth Diagnostics also has a Medical 3 Affairs information booth at SNMMI, where attendees can learn about the Company’s clinical research. For full session details and scientific presentation lists, please see the SNMMI online program here. 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. To report suspected adverse reactions to Axumin, call 1‐855‐AXUMIN1 (1‐855‐298‐6461) or contact FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch. Full Axumin prescribing information is available at https://www.axumin.com/prescribing‐ information.pdf. Indication and Important Safety Information About POSLUMA INDICATION POSLUMA® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate‐ specific membrane antigen (PSMA) positive lesions in men with prostate cancer • with suspected metastasis who are candidates for initial definitive therapy • with suspected recurrence based on elevated serum prostate‐specific antigen (PSA) level IMPORTANT SAFETY INFORMATION Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non‐malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended. 4 Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision‐making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline. POSLUMA use contributes to a patient’s overall long‐term cumulative radiation exposure. Long‐ term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers. The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain. Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established. To report suspected adverse reactions to POSLUMA, call 1‐844‐POSLUMA (1‐844‐767‐5862) or contact FDA at 1‐800‐FDA‐1088 or www.fda.gov/medwatch. Full POSLUMA prescribing information is available at www.posluma.com/prescribing‐information.pdf. About Blue Earth Diagnostics Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well‐differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro‐oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com. About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is a world‐leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X‐ray imaging (including Computed Tomography‐CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose‐management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting‐edge biotechnology vehicle to develop radiopharmaceutical therapies. Visit: www.braccoimaging.com. 5 Axumin and POSLUMA are registered trademarks of Blue Earth Diagnostics Ltd. Contact: For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice President, Corporate Communications (M) (781) 799‐7917 [email protected] For Blue Earth Diagnostics (UK) Clare Gidley Associate Director Marketing and Communications Tel: +44 (0) 7917 536939 [email protected] Media Mike Beyer (M) (312) 961‐2502 [email protected] # # # PP‐rh‐US‐0492
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