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Blue Earth Diagnostics Announces Presentation on Fluciclovine (18F) PET/CT Impact on Clinical Management of Recurrent Prostate Cancer at Upcoming AUA2018, Annual Meeting of the American Urological Association

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Blue Earth Diagnostics, a molecular imaging diagnostics company, today
announced the upcoming presentation of initial results from the LOCATE
clinical trial (NCT02680041), evaluating the impact of fluciclovine (18F)
PET/CT on planned treatment for patients with biochemical recurrence
(BCR) of prostate cancer after curative-intent primary therapy. The
presentation includes a Moderated Poster at AUA2018, the American
Urological Association Annual Meeting being held in San Francisco, Ca.,
from May 18 - 21, 2018. Details of the presentation to be given by Blue
Earth Diagnostics and its collaborators are listed below.

 
Date: Monday, May 21, 2018
Presentation:

Impact of positron emission tomography with 18F-fluciclovine
on management of patients with suspected recurrence of prostate
cancer: results from the LOCATE trial

Abstract Number: 18-6136
Session Title: Prostate Cancer: Detection & Screening VI
Moderated Poster: MP77-11
Session Time: 7 a.m. – 9 a.m. PT
Presenter:

Gerald L. Andriole, MD, Robert K. Royce Distinguished Professor
and Chief of Urologic Surgery at Washington University School of
Medicine, St. Louis, Mo., on behalf of the LOCATE study group

Location: Moscone West Building, Room 3005, San Francisco, Ca.
 

Blue Earth Diagnostics invites participants at the AUA2018, Meeting of
the American Urological Association, to learn more about the company at
Exhibit Booth 5666. The company is also hosting a Luncheon Symposium
event at the AUA 16th International Prostate Forum, with invited
speakers Dr. Ashley Ross, MD, PhD, Texas Urology Specialists and Texas
Oncology, Associate Chair, US Oncology Research Genito-Urinary
Committee, Adjunct Associate Professor of Urology, Johns Hopkins School
of Medicine, Dallas, Tex. and Dr. Rodney Ellis, MD FACRO, Vice Chairman,
Strategic Affairs, Radiation Oncology, University Hospital Cleveland
Medical Center, Associate Professor, Radiation Oncology and Urology,
Case Western Reserve University School of Medicine, Cleveland, Ohio
which will be held on Sunday, May 20, 2018, 12 p.m. – 1 p.m. PT, in MCC
West, Room 3001.

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 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 experiencing suspected biochemical
recurrence. 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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