Blue Earth Diagnostics Announces Additional Results from Phase 3 SPOTLIGHT Trial of Investigational FAMILY PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer

− Results at the American Urological Association’s 2023 Annual Meeting (AUA2023) –

MONROE AREA, N.J. & OXFORD, England, April 29, 2023–(BUSINESS WIRE)–Blue Earth Diagnostics, a Bracco business and acknowledged leader in the advancement and commercialization of ingenious family pet radiopharmaceuticals, today revealed extra arise from its finished Phase 3 SPOTLIGHT trial of ¹⁸F-rhPSMA-7.3 in frequent prostate cancer, amongst a subgroup of clients who had actually gone through main treatment with radiation treatment just. It assessed the general Detection Rates (DRs) of ¹⁸F-rhPSMA-7.3 at client level and stratified by physiological area, Gleason rating, standard Prostate Specific Antigen (PSA) levels and PSA doubling time. ¹⁸F-rhPSMA-7.3 is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted family pet imaging representative. The outcomes were reported in a moderated poster discussion at the American Urological Association’s 2023 Annual Meeting (AUA2023), in Chicago, Ill.

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“The capability to figure out the degree and area of frequent prostate cancer to notify suitable scientific management for these males is essential for doctors and their clients, since as much as 50% of clients who go through radiation treatment will establish regional or far-off reoccurrences within ten years,” said Brian T. Helfand, MD, Chief of Division of Urology, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group. “The energy of traditional imaging for the localization of reoccurrence is restricted, and regression after curative-intent radiation treatment stays a significant scientific problem. Precise imaging methods are needed to recognize locations of participation in order to help with shipment of enhanced management for clients. These findings from the Phase 3 SPOTLIGHT subgroup research study revealed high detection rates by bulk read for ¹⁸F-rhPSMA-7.3 throughout all areas. In specific, the finding that 43% (33/76) of males had far-off extra-pelvic reoccurrences has crucial ramifications for scientific management, as treatments such as salvage prostatectomy would be useless in those cases.”

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“These arises from the Phase 3 SPOTLIGHT trial in biochemically frequent prostate cancer are consisted of in our New Drug Application for ¹⁸F-rhPSMA-7.3 family pet imaging presently under evaluation by the U.S. Food and Drug Administration, and we are delighted that they are existing to the urology neighborhood at AUA 2023,” said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Diagnostics. “¹⁸F-rhPSMA-7.3 represents a brand-new class of PSMA-targeted family pet radiopharmaceuticals, with early research studies revealing a high binding affinity for PSMA, together with biodistribution information recommending the capacity for low bladder activity. The substance becomes part of Blue Earth Diagnostics’ thorough prostate cancer portfolio, that includes other substances and this investigational rhPSMA substance for prospective usage in diagnostic family pet imaging and targeted radiopharmaceutical treatment.”

The findings provided at AUA consisted of analyses of scientific aspects affecting DRs for ¹⁸F-rhPSMA-7.3 as assessed by 3 blinded main readers: DRs, general patient-level detection rate, and regional-level analyses, stratified by Gleason rating, standard PSA levels and PSA doubling time. For example, results revealed that amongst the subgroup (n=76) of clients in the Evaluable FAMILY PET Scan Population who had actually gone through main treatment with radiation treatment for prostate cancer, the general patient-level DR was 99% (75/76) and regularly high throughout the 3 independent readers (variety 93-99%). Recurrence by area was 76% (58/76) for the prostate, 25% (19/76) for pelvic lymph nodes and 43% (33/76) for extra-pelvic reoccurrences. As kept in mind formerly, no severe negative responses were credited to ¹⁸F-rhPSMA-7.3 FAMILY PET in the SPOTLIGHT research study. Of the 391 clients who received ¹⁸F-rhPSMA-7.3 in the SPOTLIGHT research study, 16 (4.1%) clients had at least one treatment-emergent negative occasion that was thought about potentially related/related to ¹⁸F-rhPSMA-7.3. The most regularly reported occasions were: high blood pressure: 1.8% (n=7); diarrhea: 1.0% (n=4); injection website response: 0.5% (n=2), and headache: 0.5% (n=2).

The SPOTLIGHT trial (NCT04186845) was a Phase 3, multi-center, single-arm imaging research study carried out in the United States and Europe to assess the safety and diagnostic efficiency of ¹⁸F-rhPSMA-7.3 family pet imaging in males with believed prostate cancer reoccurrence based upon raised PSA following previous treatment. Key results for ¹⁸F-rhPSMA-7.3 family pet were formerly provided at ASCO GU in February 2022,¹ with extra outcomes revealed at AUA in April 2022², at SNMMI in June 2022³ and at ASTRO in October 2022⁴.

The findings were talked about in a moderated poster discussion at AUA 2023 on April 29, 2023, “¹⁸F-rhPSMA-7.3 Detection Rates in Patients with Recurrence of Prostate Cancer Following Primary Treatment with Radiation Therapy: Results SPOTLIGHT Study,” by Brian T. Helfand, MD, NorthShore University HealthSystem, Evanston, Ill., on behalf of the SPOTLIGHT Study Group. Full session information and the abstract are available in the AUA online program HERE.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA substances include a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which connects to and is internalized by prostate cancer cells and they might be radiolabeled with ¹⁸F for family pet imaging, or with isotopes such as ¹⁷⁷Lu or ²²⁵Ac for healing usage – producing a real theranostic innovation. They might play an essential function in client management in the future, and use the capacity for accuracy medication for males with prostate cancer. Radiohybrid innovation and rhPSMA stemmed from the Technical University of Munich, Germany. Blue Earth Diagnostics obtained unique, around the world rights to rhPSMA diagnostic imaging innovation from Scintomics GmbH in 2018, and healing rights in 2020, and has actually sublicensed the healing application to its sibling business Blue Earth Therapeutics. Blue Earth Diagnostics has actually finished 2 Phase 3 scientific research studies examining the safety and diagnostic efficiency of ¹⁸F-rhPSMA-7.3 family pet imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in males with frequent illness and (“LIGHTHOUSE,” NCT04186819), in males with recently detected prostate cancer. Currently, rhPSMA substances are investigational and have actually not received regulative approval.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing worldwide molecular imaging business concentrated on providing ingenious, well-differentiated diagnostic options that notify client care. Formed in 2014, the Company’s success is driven by its management knowledge and supported by a shown performance history of quick advancement and commercialization of positron emission tomography (FAMILY PET) radiopharmaceuticals. Blue Earth Diagnostics’ broadening oncology portfolio includes a range of illness states, consisting of prostate cancer and neuro-oncology. Blue Earth Diagnostics is dedicated to the prompt advancement and commercialization of accuracy radiopharmaceuticals for prospective usage in imaging and treatment. For more details, please go to: www.blueearthdiagnostics.com.

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging company. Headquartered in Milan, Italy, Bracco Imaging establishes, produces and markets diagnostic imaging representatives and options. It uses an item and service portfolio for all essential diagnostic imaging methods: X-ray imaging (consisting of Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and unique family pet imaging representatives to notify scientific management and guide look after cancer clients in locations of unmet medical requirement. Our constantly developing portfolio is finished by a variety of medical gadgets, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its item portfolio by broadening the series of oncology nuclear imaging options in the urology sector and other specializeds with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging developed Blue Earth Therapeutics as a different, advanced biotechnology vehicle to establish radiopharmaceutical treatments. Visit: www.braccoimaging.com.

¹Schuster, DM, SPOTLIGHT Study Group, J. Clin. Onc. 2022; 40 (6_suppl):9-9.

²Fleming, MT, SPOTLIGHT Study Group, J. Urol. 2022; 207 (5_suppl):31047.

³Kuo, P, SPOTLIGHT Study Group, J. Nucl. Med. 2022; 63 (2_suppl):2539.

⁴Lowentritt, B, SPOTLIGHT Study Group, Int. J. Radiat. Oncol. Biol. Phys. 2022; 114(3):S130-S131.

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Contacts

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
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Mike Beyer
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