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

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

– Axumin Recently FDA-approved to Detect Recurrent Prostate Cancer –  

BURLINGTON, Mass. and OXFORD, England, June 9, 2016 – Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced the presentation of results from Axumin (fluciclovine F 18) injection studies in biochemically recurrent prostate cancer at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), from June 11-15, 2016 in San Diego, Ca. The Company will also participate in a panel presentation on new imaging agents.  Details of Axumin presentations by Blue Earth Diagnostics and its collaborators are listed below.

Date:                           Sunday, June 12, 2016

Presentation:               Fluciclovine F18 (FACBC): An Amino Acid Tracer for the Staging of Recurrent Prostate Cancer

Session Title:               New Imaging and Therapeutic Agents on the Horizon for Routine Clinical Use

Presenter:                    Jonathan Allis, D. Phil.

Presentation Time:      12:30 PM – 2:00 PM PT

Location:                     25 A

Date:                           Monday, June 13, 2016

Poster Title:                 Evidence of the effectiveness of reader training for the staging of biochemically recurrent prostate cancer using fluciclovine F18 PET-CT

Session Title:               Prostate/GU: poster session

Presenter:                    Matthew P. Miller, Ph.D.

Presentation Time:      3:00 PM – 4:30:00 PM PT

Location:                     Exhibit Hall G

Publication No.:          1556

In addition, the following presentation will be part of an independent continuing education program at SNMMI.

Date:                           Tuesday, June 14, 2016

Presentation:               Fluciclovine F18: A New Option for Biochemical Recurrence in Prostate Cancer

Session Title:               CE79 Imaging Prostate Cancer

Presenter:                    Trond V. Bogsrud, M.D., Ph.D.

Presentation Time:      2:45 PM – 4:15 PM PT

Location:                     20 BC

Blue Earth Diagnostics invites participants at this year’s SNMMI Annual Meeting to visit the Company at Exhibit Booth 337.

About AxuminTM (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 initial therapy. 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 F18 for PET imaging. Axumin was approved by the U.S. Food and Drug Administration on May 27, 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.

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 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 AxuminTM (fluciclovine F 18), a novel molecular imaging agent for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence. Blue Earth Diagnostics Inc. of Burlington, Mass., is the wholly-owned U.S. subsidiary of U.K.-based Blue Earth Diagnostics Ltd. The Company is funded by Syncona LLP, an independent subsidiary of the Wellcome Trust. For more information, visit www.blueearthdx.com.

 

Contact:

U.S.

For Blue Earth Diagnostics Inc.                          Media

Priscilla Harlan                                                                Sam Brown Inc.

Vice President, Corporate Communications             Cory Tromblee

781-799-7917                                                                   617-571-7220

p.harlan@blueearthdx.com                                         corytromblee@sambrown.com

U.K

For Blue Earth Diagnostics Ltd.

Consilium Strategic Communications

Amber Fennell

+44 (0)7739 658 783

fennell@consilium-comms.com