Blue Earth Diagnostics Announces Agreement with Siemens Healthineers to Share PET Imaging Agent POSLUMA® (Flotufolastat F 18) Clinical Data to Support AI-based Algorithms Development
2024年5月8日 - 9:30PM
ビジネスワイヤ(英語)
–Includes data from Phase 3 LIGHTHOUSE trial
evaluating POSLUMA in newly diagnosed prostate cancer–
Blue Earth Diagnostics, a Bracco company and recognized leader
in the development and commercialization of innovative PET
radiopharmaceuticals, today announced the signing of a
non-exclusive data-sharing agreement with Siemens Healthineers for
anonymized POSLUMA® (flotufolastat F 18) injection (formerly known
as 18F-rhPSMA-7.3) clinical data and images from Blue Earth
Diagnostics’ Phase 3 LIGHTHOUSE trial in newly diagnosed prostate
cancer. Siemens Healthineers plans to evaluate the data to enhance
its analytics and artificial intelligence (AI)-based algorithms for
prostate cancer image quantification and interpretation across its
advanced PET/CT imaging software. 18F-flotufolastat is an
optimized, high-affinity radiohybrid (rh) Prostate-Specific
Membrane Antigen-targeted agent approved in the United States 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 or with suspected recurrence based on elevated serum
prostate-specific antigen (PSA) level.
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“Blue Earth Diagnostics is committed to helping men with
prostate cancer across the care continuum, and we recognize the
importance of AI in advancing healthcare,” said David Gauden,
D.Phil., Chief Executive Officer, Blue Earth Diagnostics. “AI-based
algorithms have the potential to streamline the PET/CT analytical
workflow for hospitals and imaging centers by efficiently providing
physicians with information critical to patient management and
care. Blue Earth Diagnostics has a long-standing relationship with
Siemens Healthineers, a leading medical technology company
pioneering breakthroughs in healthcare.”
Dr. Gauden continued, “We are excited to provide these
anonymized POSLUMA data from our LIGHTHOUSE trial, for use in
enhancing the Siemens Healthineers syngo.via platform. We also plan
to make analytical data from the Phase 3 SPOTLIGHT trial of POSLUMA
available in the future. POSLUMA represents a new class of
high-affinity PSMA-targeted radiopharmaceuticals based on novel
radiohybrid technology, and provides physicians with clinically
useful information based on its performance at low PSA levels, PSMA
binding and low urinary bladder activity. Our product is included
in nationally recognized clinical oncology guidelines for prostate
cancer, alongside and for all the same categories as the other
currently FDA-approved PSMA PET radiopharmaceuticals, and covered
by the vast majority of insurance plans. POSLUMA is labeled with
the radioisotope fluorine-18 (18F) to leverage high image quality
and to enable broad, readily available geographic access for
patients via the manufacturing and distribution network of our
commercial U.S. manufacturer and distributor, PETNET Solutions Inc,
A Siemens Healthineers Company.”
“We believe that the LIGHTHOUSE trial data will be enormously
helpful in tailoring our AI technology to support the
quantification and clinical interpretation of POSLUMA PET/CT images
and are pleased to collaborate with Blue Earth Diagnostics on this
data-sharing agreement,” said Bruce Spottiswoode, Ph.D., Director,
Clinical Applications Research, Siemens Healthineers. “The neural
networks we are using have been shown to learn radiotracer-specific
PET uptake, and we expect them to more efficiently identify
clinically relevant features in 18F-flotufolastat images.”
The LIGHTHOUSE clinical trial (NC04186819) was an open-label,
prospective, Phase 3, multi-center, single-dose, imaging study
investigating the safety and diagnostic performance of POSLUMA PET
imaging in men with newly diagnosed unfavorable intermediate-risk,
high-risk, or very high-risk prostate cancer. The study enrolled
356 patients at clinical sites in the United States and Europe. The
SPOTLIGHT study (NCT04186845) was an open-label, prospective, Phase
3, multi-center, single-dose, imaging study investigating the
safety and efficacy of POSLUMA PET imaging in men with suspected
prostate cancer recurrence. The study enrolled 391 patients at
clinical sites in the United States and Europe.
About Radiohybrid Prostate-Specific Membrane Antigen
(rhPSMA) Radiohybrid Prostate-Specific Membrane Antigen
(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 imaging isotopes for PET imaging, or with
therapeutic isotopes for therapeutic use – providing the potential
for creating a true theranostic technology. 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 sublicensed the
therapeutic application to its sister company Blue Earth
Therapeutics. Blue Earth Diagnostics received U.S. Food and Drug
Administration approval for its radiohybrid PET diagnostic imaging
product for use in prostate cancer in 2023. rhPSMA compounds for
potential therapeutic use are investigational and have not received
regulatory approval.
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.
- 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.
POSLUMA is a registered trademark of Blue Earth Diagnostics
Ltd.
PP-rh-US-0481
This press release is for U.S. audiences only
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For Blue Earth Diagnostics (U.S.) Priscilla Harlan Vice
President, Corporate Communications (M) (781) 799-7917
priscilla.harlan@blueearthdx.com
For Blue Earth Diagnostics (UK) Clare Gidley Associate
Director Marketing and Communications Tel: +44 (0)1865 784186
clare.gidley@blueearthdx.com
Media Sam Brown Inc. Mike Beyer (M) (312) 961-2502
mikebeyer@sambrown.com