Blue Earth Diagnostics Announces Publication of Reader Training Study Results for AxuminTM (Fluciclovine F 18) PET Imaging of Men with Recurrent Prostate Cancer

Published 03 May 2017

Blue Earth Diagnostics, a molecular imaging diagnostics company, announced the peer-reviewed publication of results from the reader training component of Axumin Phase 3 registration data that evaluated the impact of reader training on the blinded, independent evaluation of Axumin (fluciclovine F 18) images.

Axumin is a novel, FDA-approved molecular imaging agent indicated for use in positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. Results of this study, based on PET/CT (computed tomography) images from the Axumin image database at Emory University, Atlanta, Ga., demonstrated that, with standardized Axumin reader training, previously na?ve readers were able to achieve acceptable diagnostic performance and reproducibility when using Axumin PET/CT images to re-stage patients with biochemically recurrent prostate cancer.

The manuscript, “Reader training for the re-staging of biochemically recurrent prostate cancer using fluciclovine (18F) PET/CT,” was accepted by The Journal of Nuclear Medicine and is now available online: J Nucl Med 2017; doi: 10.2967/jnumed.116.188375. The manuscript will also appear in an upcoming print issue. Lead authors are M. Miller of Blue Earth Diagnostics, Oxford, UK; L. Kostakoglu of Icahn School of Medicine at Mount Sinai, New York, NY; D. Pryma, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pa. and J. Yu of Fox Chase Cancer Center, Philadelphia, Pa. Significant contributions to the reader training study were provided by the Society of Nuclear Medicine and Molecular Imaging’s Clinical Trial Network and the American College of Radiology.

“This Phase 3 study demonstrated that reader training is effective in enabling physicians new to Axumin PET/CT image interpretation to replicate results from an expert center,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics Ltd. “Axumin use in the United States continues to expand from expert technical centers into general clinical use. In addition to this increasing U.S. commercial availability and access, Blue Earth Diagnostics Inc., in collaboration with the SNMMI’s Nuclear Medicine Clinical Trial Group, continues to provide reader training in image acquisition and interpretation to new users of Axumin as part of our commitment to helping men with recurrent prostate cancer.”

“Commonly used imaging techniques for the identification of suspected recurrent prostate cancer are limited in the information they provide, leaving physicians with difficult medical challenges in defining appropriate care for their patients,” said Lale Kostakoglu, MD, MPH, Professor of Radiology and Chief of Nuclear Medicine, Icahn School of Medicine at Mount Sinai, New York, NY. “This study demonstrated that Axumin reader training enabled overall consistent image interpretation at the patient level and for regional sites of recurrence. In my experience, PET/CT imaging with Axumin effectively detects and localizes recurrent disease, which can help guide my patient management decisions.”

About the AxuminTM Phase 3 Reader Training Study

This Phase 3 study assessed the ability of readers without prior experience in reading Axumin PET/CT images (“na?ve readers”) to interpret images from men with biochemically recurrent prostate cancer with acceptable diagnostic performance and reproducibility. Primary objectives were to establish individual readers’ diagnostic performance and the overall interpretation (2/3 reader concordance) compared to standard of truth data (histopathology (i.e., biopsy) and/or clinical follow-up) and to evaluate reproducibility of interpretation among the readers. Standardized image interpretation methodology was established in conjunction with the SNMMI Clinical Trials Network, with the blinded independent evaluation conducted at the American College of Radiology Clinical Research Center.

Axumin images and standard of truth data from 110 patients with biochemically recurrent prostate cancer were collected from Emory University, Atlanta, Ga. Three independent readers were trained using standardized interpretation methodology, who then evaluated Axumin images in a blinded manner. Analyses of 121 images were conducted at several levels: lesion; prostate region (prostate, including prostate bed and seminal vesicles) and extraprostatic (including all lymph nodes, bone or soft tissue metastases); and patient.

Results demonstrated that the overall ability of the readers to classify Axumin uptake as malignant at the lesion level had a Positive Predictive Value (PPV) of 71% (98/139). The PPV at the region level was 73% (53/73) for the prostate region and 92% (24/26) for the extraprostatic region. The PPV at the patient level was 79% (68/86). The Readers’ PPV and Negative Predictive Value (NPV) were broadly consistent for the regions that were measureable, with each other and with the onsite read. Overall Sensitivity (SEN) at the patient level was 92% (68/74). The SEN at the region level was 91% (53/58) for the prostate region and 86% (24/28) for the extraprostatic region; and 64% at the lesion level. Importantly, readers in this study were able to identify areas of recurrent cancer on fluciclovine (18F) PET/CT images with comparable accuracy to fluciclovine-experienced readers who had access to histopathological findings and subject data, as reported in the literature (Bach-Gansmo T, et al. J Urol 2017;197:676-83).

Though interpretation errors can occur and clinical correlation is still recommended, the authors concluded that standardized interpretation methodology and a specific training program for evaluating Axumin images enables na?ve readers to achieve acceptable diagnostic performance and reproducibility when staging recurrent prostate cancer. Blue Earth Diagnostics provided financial support for the study.

For the latest information on Axumin image interpretation training, please contact Blue Earth Diagnostics, Inc.’s Medical Information Hotline at medinfo@blueearthdx.com or 1-855-AXUMIN1 (298-6461); Option 3 or visit SNMMI’s Nuclear Medicine Clinical Trial Group: www.snmmi.org/research/index.aspx?navItemNumber=673

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 Prostate / Recurrent Prostate Cancer

Prostate cancer is the second leading cause of cancer death in men in the United States. While most primary prostate cancer can be successfully treated, the disease recurs in approximately one-third of patients. In some patients recurrent disease is detectable only by a rise in prostate specific antigen (PSA) levels, yet the location of the recurrence cannot consistently be located by conventional imaging, potentially impacting subsequent management of these patients.

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

Contact

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

Media
Sam Brown Inc.
Cory Tromblee
(M) (617) 571-7220
corytromblee@sambrown.com

For Blue Earth Diagnostics Ltd. (UK)
Dr. Val Jones
Val Jones PR Ltd
(M) +44 (0) 7917 175 192
v.jones@blueearthdx.com

Syncona Limited Disclaimer

Please read the below disclaimer carefully. You will be asked to accept these terms and conditions before proceeding.

The information on this website is directed only at persons who are shareholders in Syncona Limited (the “Company”) and is provided for their exclusive use and benefit.

Users of this website are responsible for observing all applicable laws and regulations in their relevant jurisdictions before proceeding to access the information contained herein. By proceeding to access the information, users are deemed to be representing and warranting that the applicable laws and regulations of their relevant jurisdiction allow them to do so. No information, materials or opinions contained on this website (“Materials”) constitute or would be deemed to constitute a recommendation or invitation in any jurisdiction to invest or otherwise deal in the shares of the Company (the “Shares”).

The website that you are seeking to access does not constitute an offer to buy or sell the securities mentioned in the website in any jurisdiction or jurisdictions in which such offers or sales are unlawful prior to registration or qualification under the securities laws of any such jurisdiction. In particular, the securities mentioned in the website have not been and will not be registered under the United States Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration or exemption from registration under the Securities Act and other securities laws. There will be no public offer of these securities in the United States. Offers and sales of these securities, and distribution of the related information, may also be subject to restrictions in other jurisdictions.

The website that you are seeking to access is not directed at and may not be viewed by or distributed to persons:

  • in the United States or who are U.S persons (as defined in Rule 902 under the Securities Act);

or

  • located in a jurisdiction where it is not lawful to access the materials.

The Materials are provided on an “as is” and “as available basis” and do not purport to be full or complete. The Company and its affiliates believe that the source of the Materials is reliable however they cannot and do not guarantee, either expressly or implicitly, and accept no liability for, the accuracy, validity, timeliness, merchantability or completeness of any information or data (whether prepared by the Company, its affiliates or by any third party) for any particular purpose or use or that the information or data will be free from error. The Company and its affiliates do not undertake any responsibility for any reliance which is placed by any person on any statements or opinions which are expressed herein. Neither the Company, nor any of its affiliates, directors, officers or employees will be liable or have any responsibility of any kind for any loss or damage that any person may incur resulting from the use of this information.Nothing contained in this website constitutes financial, investment, legal, tax or other advice and is not to be relied on in making an investment or other decision. You should obtain relevant and specific professional advice before making any investment decision.

The Materials on this website are provided for your personal use and informational purposes only and are subject to change without notice. The Company has the right to suspend or withdraw the provision of all or any of the website of the Materials without prior notice at any time.

The value of investments mentioned in this site, and the income from them may go down as well as up and investors may not get back the amount invested. Information on past performance, where given, is not a guide to future performance. Changes in rates of exchange between currencies may cause the value of investments to decrease or increase.
The Company is a registered closed-ended collective investment scheme registered pursuant to the Protection of Investors (Bailiwick of Guernsey) Law, 1987, as amended (the ‘‘POI Law’’) and the Registered Collective Investment Scheme Rules 2008 (the ‘‘CIS Rules’’) issued by the Guernsey Financial Services Commission (the ‘‘GFSC’’). Neither the GFSC nor the States of Guernsey Policy Council take any responsibility for the financial soundness of the Company or for the correctness of any of the statements made or opinions expressed with regard to it.

Copyright

Copyright of all images and text in this website is owned by or licensed to the Company or one of its affiliates unless otherwise noted. You may imprint, copy, download or temporarily store extracts from this website for your personal information and use. Any other use is prohibited unless you first request and obtain the prior written consent of the Company. You may not alter or otherwise make any changes to any material that you print or download from this website, including, without limitation, removing any identifying marks or legends from such material. In particular, you may not copy or use any part of this website on any other website, or link any other website to this website, without the prior written permission of the Company. You may not use the website for any purpose which is unlawful, abusive, libellous, obscene or threatening.

No Warranty

The Materials contained in this website are provided without any warranty of any kind, either expressed or implied, to the fullest extent permissible pursuant to applicable law. Neither the Company nor its affiliates assume any responsibility for the uninterrupted availability of this website or warrant that it will be error-free, that defects will be corrected, or that this website or the servers that make it available will be free of viruses or other harmful components.

Liability Waiver

You agree that under no circumstances, including, but not limited to, negligence, shall the Company or any of its affiliates be liable for any special or consequential damages that result from the access or use of, or the inability to access or use, the Materials on this website. This does not exclude or restrict any duty or liability that the Company has to its customers under the regulatory system in the United Kingdom or Guernsey.

Privacy Policy

This policy sets out what the Company and its affiliates do with any personal information collected from this website.

Any personal information collected from this website will be processed in accordance with relevant data protection laws.

You may use the public areas of this website without providing the Company or its affiliates with any personal information and the Company and its affiliates do not monitor or collect any personal information through your access to the public areas of this website. The Company and its affiliates do not use cookies to collect information but may gather other anonymous information to assist in improving the services.

If you chose to provide the Company and its affiliates with personal information, this information will only be used for the purposes of the service that you have requested. The Company and its affiliates will not sell or transfer any personal information to third parties without your permission, other than as required by law.

The Company and its affiliates are not responsible for the content or privacy policies of websites to which this website may link.

The Company and its affiliates are committed to protecting your personal information but in the event that the system is infiltrated by unauthorised third parties the Company and its affiliates will not be liable for any resulting misuse of personal information.

Linked Sites

The Company has not reviewed any website linked to this website and is not responsible for the contents of off-site pages or any other websites linked or linking to this website. If you follow any links from this website you do so at your own risk.

Links to this website may not be established without the prior written consent of the Company.

Governing Law

The terms and conditions of this legal notice shall be governed by and construed in accordance with the laws of Guernsey. Users of this website agree that any dispute or action arising out of or relating to these terms or any user’s use of this website shall be commenced only in the courts located in Guernsey, and users of this website hereby consent and submit to the exclusive jurisdiction of such courts for the purposes of any such dispute or action.

By accessing Materials on this website you agree to be bound by the foregoing limitations.