Blue Earth Diagnostics Inc. of Burlington, Massachusetts, announced that it is presenting results from studies that led to the recent U.S. Food and Drug Administration (FDA) approval of its molecular imaging agent Axumin (fluciclovine F 18) to identify prostate cancer recurrence. The presentations are taking place at the Society of Nuclear Medicine and Molecular Imaging meeting now underway in California.

Axumin is the first F-18 PET imaging agent approved for use in patients with suspected recurrent prostate cancer.

Blue Earth Diagnostics (BED)’s chief executive officer, Jonathan Allis, said in a release: “FDA approval of Axumin is a major milestone for BED, as well as for prostate cancer patients and their physicians. We hope Axumin will be the first in a suite of products to assist in the diagnosis of disease. We look forward to Axumin being increasingly available in the coming months in the US via our US vendor and to subsequent global approvals.”

Axumin is indicated for positron emission tomography (PET) imaging in men in whom prostate cancer recurrence is suspected based on elevated blood prostate specific antigen (PSA) levels following initial treatment for the disease. High PSA in the blood is a sign that cancer is coming back or spreading. PET imaging with Axumin may identify the location and extent of such a recurrence.

The Axumin product, which was developed to enable visualization of increased amino acid transport characteristic in many cancers, including prostate cancer, 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 — in which a special type of camera and a tracer (radioactive chemical) are used to examine bodily biochemical processes.

During a PET scan, tracer liquid is intravenously injected into the patient’s arm, and moves through the body, where much of it collects in the target organ or tissue. The tracer gives off tiny positively charged particle (positron) emissions, which the camera records and renders in pictures. PET scan images show biological function and are complimentary with computed tomography (CT) scans or magnetic resonance imaging (MRI), which show anatomical information.

Axumin is the first product commercialized by BED, a majority-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, which licensed the product from GE Healthcare. The product approval is the first for Syncona, which was formed in October 2012 to support transformational science with the capital and capability to build standalone businesses.

Martin Murphy, chief executive officer of Syncona, said in a release: “Syncona’s aim has always been to create standalone companies with the ambition of taking their products to market we believe this approach will deliver both significant patient outcomes and attractive financial returns. The FDA approval … is a demonstration of the success of this model and we look forward to working with the BED team as they launch Axumin in the US and seek product approval in other global markets.”

Blue Earth Diagnostics Ltd. and Siemens PETNET Solutions, a wholly owned subsidiary of Siemens Medical Solutions USA, Inc., announced the commercial availability of Axumin injection in the United States on June 7, just weeks after its May 27, 2016, FDA approval. Axumin will be commercially available through PETNET Solutions, which operates the largest network of PET radiopharmacies, with over 50 locations worldwide. Initial commercial Axumin production will be underway at certain of these radiopharmacies, with increasingly availability planned for the coming months.

“We hope that this will make a real difference to patients and their physicians,” Allis said. “Blue Earth Diagnostics is extremely pleased to be working with Siemens PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States; we both share a passion for PET molecular imaging, and for providing imaging tools to improve patient management.”

“This is a significant milestone for the PET industry, as this is the first proprietary F-18 labeled agent for an oncology indication approved by the FDA. And, being F-18 labeled enables efficient distribution and wide patient access,” said Barry Scott, head of Siemens PETNET Solutions. “Through our broad network of radiopharmacies we are able to increase access to PET tracers, like Axumin, helping healthcare providers to address society’s most challenging diseases. We are proud to work with Blue Earth Diagnostics as the U.S. commercial supplier making Axumin available to imaging centers and their patients.”

Blue Earth Diagnostics is presenting results from Axumin injection studies in recurrent prostate cancer at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI) running through June 15 in San Diego, California.

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:

Sunday, June 12, 12:30 p.m. to 2:00 p.m. Presentation at 25 A:
Fluciclovine F18 (FACBC); New Imaging and Therapeutic Agents on the Horizon for Routine Clinical Use — An Amino Acid Tracer for the Staging of Recurrent Prostate Cancer. The presenter will be Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics Ltd.

Monday, June 13, 3:00 p.m. to 4:30 p.m., PT Exhibit Hall G Poster presentation:
Prostate/GU — Evidence of the effectiveness of reader training for the staging of biochemically recurrent prostate cancer using fluciclovine F18 PET-CT. Presenter will be Matthew P. Miller, PhD,
head of Imaging and Project Management at Blue Earth Diagnostics.

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

Tuesday, June 14, 2:45 p.m. to 4:15 p.m. PT 20 BC Presentation:
CE79 Imaging Prostate Cancer Fluciclovine F18: A New Option for Biochemical Recurrence in Prostate Cancer. Presenter will be Trond V. Bogsrud, MD, PhD, Oslo University (Norway).

Blue Earth Diagnostics and Siemens PETNET Solutions are also inviting participants at this year’s SNMMI meeting to visit their exhibit booths. Blue Earth Diagnostics is at Booth 337; Siemens PETNET Solutions is at Booth 431.

Dr. Jeremy Farrar, director of the Wellcome Trust, said: “Wellcome founded Syncona to deliver impact to patients from world-class research. By enabling doctors to pinpoint exactly where the cancer has recurred, they can determine the best course of treatment for those affected, and hopefully save lives. Bringing this important innovation to fruition so quickly is a real testament to the BED and Syncona teams, and achieving FDA approval for Axumin shows that this approach allows great ideas to thrive.”

The Wellcome Trust is a global charitable foundation that provides more than £700 million a year to support bright minds in science, the humanities and the social sciences, as well as education, public engagement and the application of research to medicine.

Prostate cancer is the second leading cause of cancer death in men in the U.S. While most primary prostate cancer can be successfully treated, up to one-third of patients experience recurrence following initial treatment that is typically detected by elevated PSA levels. The location and extent of the disease cannot always be detected by conventional imaging, however, and of those who experience recurrence, approximately one-third develop metastatic prostate cancer. Better understanding of a recurrence can facilitate management decisions that include surgery, radiotherapy, or chemotherapy.

“Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels, said Libero Marzella, MD, PhD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research. “Axumin is shown to provide another accurate imaging approach for these patients.”

The safety and efficacy of Axumin were evaluated in two retrospective trials (Trial 1 and Trial 2) for imaging prostate cancer in patients with recurrent disease. Trial 1 compared 105 Axumin scans in men with suspected prostate cancer to the histopathology (study of tissue changes caused by disease) obtained by prostate biopsy, and by biopsies of suspicious imaged lesions. PET/CT imaging generally included the abdomen and pelvic regions. The images were subsequently read by three independent readers. Onsite radiologists read the scans initially; subsequently, three independent radiologists read the same scans in a blinded study.

Trial 2 evaluated the concordance between 96 Axumin and C11 choline scans in patients with median PSA values of 1.44 ng/mL. Radiologists onsite read the C 11 choline scans, and the same three independent radiologists from Study 1 read the scans in this second blinded study. The FDA reported that results of the independent scan readings were generally consistent and confirmed the onsite scan reading results, and both studies supported the safety and efficacy of Axumin for imaging prostate cancer in men with elevated PSA levels following prior treatment.

The FDA has posted a Drug Trials Snapshot for Axumin at www.fda.gov/drugs/informationondrugs/ucm505750.htm.

Sources:
Blue Earth Diagnostics Inc.
U.S. Food and Drug Administration (FDA)
Siemens PETNET Solutions, Inc.
Society of Nuclear Medicine and Molecular Imaging Annual Meeting (SNMMI)
Syncona LLP
Wellcome Trust