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Blue Earth Diagnostics Announces Fluciclovine F 18 Research Presentations at Upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting

Blue Earth Diagnostics, a molecular imaging diagnostics company, today
announced that presentations related to the clinical use of fluciclovine
F 18 injection will be occurring at the Society of Nuclear Medicine and
Molecular Imaging Annual Meeting (SNMMI), from June 23 – 26, 2018 in
Philadelphia, Pa. In addition, a special program led by SNMMI,
“Fluciclovine Live Reader Training,” will be held immediately prior to
the Annual Meeting. The oral and poster presentations highlighting
ongoing investigations with fluciclovine F 18 are listed below.

ORAL PRESENTATION

Tuesday, June 26, 2018

SS54: Prostate Cancer Imaging II

18F-Fluciclovine PET/CT in patients with
biochemical recurrence of prostate cancer: Impact on management
and associations of clinical variables with scan findings

POSTER PRESENTATIONS

Monday, June 25, 2018

The role of fluciclovine (18F) PET/CT
directed, 3D ultrasound-guided fusion targeted biopsy in the
detection of biochemically recurrent prostate cancer*

Think outside the box: tackling fluciclovine PET-CT with
challenging extraprostatic findings

Probability of a positive F-18 fluciclovine scan based on level
of PSA

Utilization of F-18 fluciclovine PET/CT for initial staging of
prostate carcinoma*

Factors influencing the positivity rate of commercial 18F-Fluciclovine
PET/CT imaging in men with suspected recurrent prostate cancer

Single academic center experience with 18F-fluciclovine PET/CT
in prostate cancer management

Clinical experience with F-18-fluciclovine (Axumin®) in
prostate cancer patients with a rising PSA after primary treatment

18F-Fluciclovine for the restaging of
patients with biochemical recurrence of prostate cancer and the
correlation with PSA values: Results from a single centre

*Note: Axumin® (fluciclovine F 18) injection is FDA-approved 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. Presentations noted by
“*” are investigational studies.

Blue Earth Diagnostics invites participants at this year’s SNMMI Annual
Meeting to visit the company at Exhibit Booth 607. Blue Earth
Diagnostics is participating in SNMMI’s Interactive Training Showcase
events on the Exhibit floor, scheduled for Sunday, June 24, 2018, and
Monday, June 25, 2018 from 2 – 2:30 p.m. ET.

U.S. 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

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 www.axumin.com.

About Axumin® (fluciclovine F 18)

Axumin® (fluciclovine F 18) injection is a novel product indicated for
use in positron emission tomography (PET) imaging to identify suspected
sites of prostate cancer recurrence in men. Recurrence of prostate
cancer is suspected by an increase in prostate specific antigen (PSA)
levels following prior treatment. PET imaging with Axumin may identify
the location and extent of such recurrence. Axumin was developed to
enable visualization of the increased amino acid transport that occurs
in many cancers, including prostate cancer. It consists of a synthetic
amino acid that is preferentially taken up by prostate cancer cells
compared with surrounding normal tissues and is labeled with the
radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at
Emory University in Atlanta, Ga., with much of the fundamental clinical
development work carried out by physicians at Emory University’s
Department of Radiology and Imaging Sciences. Axumin was approved by the
U.S. Food and Drug Administration in May 2016, following Priority
Review, and is the first product commercialized by Blue Earth
Diagnostics, which licensed the product from GE Healthcare. The molecule
is being investigated by Blue Earth Diagnostics for other potential
cancer indications, such as glioma.

About Blue Earth Diagnostics

Blue Earth Diagnostics is a leading molecular imaging diagnostics
company focused on the development and commercialization of novel PET
imaging agents to inform clinical management and guide care for cancer
patients in areas of unmet medical need. Formed in 2014, Blue Earth
Diagnostics is led by recognized experts in the clinical development and
commercialization of innovative nuclear medicine products. The company’s
first approved and commercially available product is Axumin®
(fluciclovine F 18), a novel molecular imaging agent approved in the
United States and European Union for use in PET imaging to detect and
localize prostate cancer in men with a diagnosis of biochemical
recurrence. The company’s pipeline includes Prostate Specific Membrane
Antigen (PSMA)-targeted radiohybrid (“rh”) agents. rhPSMA is a
clinical-stage, investigational class of theranostic compounds, with
potential applications in both the imaging and treatment of prostate
cancer. Blue Earth Diagnostics is backed by Syncona, an
investment company listed on the London Stock Exchange (LON: SYNC). For
more information, visit: www.blueearthdiagnostics.com.

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