Blue Earth Diagnostics Announces Axumin® (Fluciclovine F 18) LOCATE Study Presentation at Upcoming ASCO 2019 Genitourinary Cancers Symposium on Impact on Clinical Management of Recurrent Prostate Cancer

BURLINGTON, Mass. & OXFORD, England–(BUSINESS WIRE)–Blue Earth Diagnostics, a molecular imaging diagnostics company, today
announced the upcoming presentation of additional analyses from the
LOCATE clinical trial (NCT02680041). The LOCATE trial is a prospective,
U.S., multicenter, open-label study investigating the impact of 18F
fluciclovine PET/CT imaging on patient management of biochemically
recurrent prostate cancer after initial prostate cancer treatment and
negative or equivocal findings on standard-of-care imaging. The
presentation will be made at the ASCO 2019 Genitourinary Cancers
Symposium (ASCO GU), from February 14-16, 2019 in San Francisco, Ca.
Details of the presentation to be given by Blue Earth Diagnostics
collaborators is listed below.

 
Date: Thursday, February 14, 2019

Presentation:

Identification of bone involvement in patients with prostate
cancer recurrence using
18F-fluciclovine
PET/CT and impact on subsequent management
Abstract Number:

248

Presenter: Michael S Kipper, MD, Genesis Healthcare, on behalf of the LOCATE
study group
Session Title & Times: Poster Session A: Prostate Cancer
11:30 AM-1:00 PM and 5:30 PM-6:30 PM PT
Location: Moscone West Building, San Francisco, Ca.
 

Blue Earth Diagnostics invites participants at the ASCO Genitourinary
(GU) Cancers Symposium 2019 to attend the above presentation and to
learn more about the company at Exhibit 36.

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

  • 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 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.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan
Vice
President, Corporate Communications
(M) (781) 799-7917
p.harlan@blueearthdx.com

Media
Sam Brown Inc.
Mike Beyer
(M) (312) 961-2502
mikebeyer@sambrown.com

For Blue Earth Diagnostics (UK)
Georgina Mowatt
Communications
Manager
Tel: +44 (0) 7810 355 912
g.mowatt@blueearthdx.com

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