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

08:00 EDT 6 Jun 2017 | Businesswire
Blue Earth Diagnostics

Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced that several presentations related to fluciclovine F 18 injection will be occurring at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI), from June 10-14, 2017 in Denver, Colo. Presentations will cover topics including clinical utilization, product development and manufacturing, clinical research, and biological characterization. In addition to these presentations, a special program, “Fluciclovine Live Reader Training,” will be held immediately prior to the Annual Meeting and led by SNMMI. Details of fluciclovine F 18 presentations by Blue Earth Diagnostics and its collaborators are listed below.

 

Sunday, June 11, 2017

Presentation:    

AxuminTM (Fluciclovine F 18): Current status and future clinical applications

Session Title: CMIIT Emerging Technologies: Updates on NETSpot, Axumin and a Look to the Future of O15 Water
Session Time: 4:30 – 6:00 PM MT
Presentation Time: 5:00 – 5:30 PM MT
Presenter: Jonathan Allis, D. Phil.
Location: Room 203
 

An extensive amount of scientific research continues on fluciclovine F 18, and the presentations highlighting these investigations follow.

 

Sunday, June 11, 2017

Poster Title:    

Production of Fluciclovine F18 (FACBC) on a Siemens PETNET GN Platform*

Session Title: Special MTA: Novel radiochemistry and chelation posters
Presenter: Michael S. Haka, PhD
Presentation Time: 7:00 – 8:30 PM MT
Location: Exhibit Hall C
Publication No.: 893
 
   

Monday, June 12, 2017

Poster Title:

Fluciclovine (18F) is a marker for high-affinity glutamine transport ASCT2- mediated amino acid transport in breast cancer*

Session Title: MTA: Oncology: Basic, Translational and Therapy (Basic Science) Posters
Presenter: Eugene J. Teoh, MRCP FRCR

Presentation Time:

3:00 – 4:30 PM MT
Location: Exhibit Hall C, Room Hall C
Publication No.: 1028
 
Poster Title:

18F-fluciclovine PET/CT in comparison with 11C-choline PET/CT for nodal staging in prostate cancer*

Session Title: MTA Prostate Posters
Presenter: Lucia Zanoni, MD
Presentation Time: 3:00 – 4:30 PM MT
Location: Exhibit Hall C
Publication No.: 1076
 
 

Tuesday, June 13, 2017

Poster Title:    

Bayesian penalised likelihood reconstruction of fluciclovine (18F) PET for imaging of recurrent prostate cancer: semi-quantitative and clinical evaluation*

Session Title: MTA II: Image Generation Posters
Presenter: Eugene J. Teoh, MRCP FRCR
Presentation Time: 2:45 – 4:15 PM MT
Location: Exhibit Hall C
Publication No.: 1368
 
 

Wednesday, June 14, 2017

Session Title:     SS84: Technical Advances and Quantification II
Presentation Title:

Impact of PSF reconstruction on clinical trial qualification and patient SUVs*

Presenter: Paul E. Kinahan, PhD
Session Time: 8:00 AM–9:30 AM MT
Presentation Time: 8:20 AM MT
Location: 603
Publication No: 717
 

In addition, the following presentations will be part of independent continuing education programs at SNMMI.

 

Monday, June 12, 2017

Session Title:     CE30: Integrating Newly Approved Radiopharmaceuticals in Your Clinic
Presentation:

Are You Ready to Mingle with F-18 Fluciclovine?*

Presenter: William C. Lavely, MD
Session Time: 10:00 – 11:30 AM MT
Presentation Time: 10:30-11:00 AM MT
Location: Mile High 1D-F
 
 

Wednesday, June 14, 2017

Presentation:    

Fluciclovine: Its Use in Breast Cancer*

Session Title: CE94: Teaching Old Radiopharmaceuticals New Tricks
Presenter: Gary Ulaner, MD
Session Time: 8:00 – 9:30 AM MT
Presentation Time: 8:20 – 8:40 AM MT
Location: Mile High 4E – 4F
 

*Note: 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. Axumin (fluciclovine F 18 ) is not approved for use in patients with breast cancer or primary prostate cancer in either the USA or Europe.

Blue Earth Diagnostics invites participants at this year’s SNMMI Annual Meeting to visit the company at Exhibit Booth 808.

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 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 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 funded by Syncona, an investment company listed on the London Stock Exchange (LON: SYNC). For more information, visit: www.blueearthdiagnostics.com.

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan
Vice President, Corporate Communications
(M) 781-799-7917
p.harlan@blueearthdx.com
or
Media
Sam Brown Inc.
Mike Beyer
(M) 312-961-2502
mikebeyer@sambrown.com
or
For Blue Earth Diagnostics (UK)
Val Jones PR Ltd
Dr. Val Jones
(M) +44 (0) 7917 175 192
v.jones@blueearthdx.com

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