Results from Blue Earth Diagnostics’ LOCATE Trial Show 59% of Patients with Suspected Recurrent Prostate Cancer Had Change in Management Plan Following 18F Fluciclovine PET/CT Scan

Published 21 May 2018

Topline results presented at AUA 2018 evaluate clinical utility of 18F fluciclovine PET/CT imaging in men with recurrent prostate cancer following prior treatment

Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced the topline results from an investigational clinical trial (“LOCATE”) evaluating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging. The LOCATE trial is a prospective, multi-center, open-label study (NCT02680041) conducted at 15 sites in the United States. Its primary endpoint measured the percentage of men with suspected biochemical recurrence of prostate cancer following initial prior therapy whose treatment plan was changed following an 18F fluciclovine PET/CT scan.

Axumin® (fluciclovine F 18 injection) is an FDA-approved molecular imaging agent 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. (For additional product information please see the end of this news release.)

The LOCATE trial recorded a patient’s intended treatment plan prior to 18F fluciclovine PET/CT and then recorded how it was altered after patients and their physicians had reviewed the results of the scan. Results of the trial indicated that 59% (126/213) of patients had their clinical management changed when results of the 18F fluciclovine PET/CT imaging were added to the diagnostic work-up. Of those changes, 78% (98/126) were classified as “major” (i.e., a change in treatment modality).

The topline results were presented in a Moderated Poster Session, “Impact of positron emission tomography with 18F-fluciclovine on management of patients with suspected recurrence of prostate cancer: results from the LOCATE trial,” by 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, at AUA 2018, the American Urological Association Annual Meeting, being held in San Francisco Ca., from May 18 - 21, 2018.

The LOCATE trial prospectively enrolled men with suspected biochemical recurrence of prostate cancer based on rising prostate-specific antigen (PSA) levels following previous curative-intent treatment and with negative or equivocal findings on standard-of-care imaging. The primary endpoint was to measure the percentage of patients with suspected biochemical recurrence of prostate cancer after therapy for primary disease whose planned treatment was altered following imaging with 18F fluciclovine PET/CT. Of the 128 patients whose original treatment plan was salvage radiation therapy (with or without androgen deprivation therapy, or ADT), 51% (65/128) had their treatment changed after 18F fluciclovine PET/CT. Of the 60 patients originally planned to be treated with ADT, 45/60 (75%) had their treatment changed to a non-systemic salvage treatment after 18F fluciclovine PET/CT, with 30 of these changes to a non-systemic salvage treatment and 11 to watchful waiting. The safety profile of 18F fluciclovine in the LOCATE trial is consistent with that described in the approved U.S. Prescribing Information.

“We are very pleased to share these LOCATE study topline results with the prestigious urology community at AUA 2018,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “As part of our mission to develop and commercialize innovative PET imaging agents for cancer, Blue Earth Diagnostics conducted the LOCATE study in the United States to evaluate the utility of 18F fluciclovine PET/CT in providing physicians with actionable information for the management of men with recurrent prostate cancer. We plan to publish the results from the LOCATE trial in an upcoming peer-reviewed publication.”

“The LOCATE study evaluated men with suspected biochemically recurrent prostate cancer whose conventional imaging scans were either negative or equivocal, and compared their treatment plans before and after 18F fluciclovine PET/CT to assess whether or not it impacted their management,” said Gerald L. Andriole, MD, the Robert K. Royce Distinguished Professor and Chief of Urologic Surgery at Washington University School of Medicine in St. Louis and presenting author on behalf of the LOCATE study group. “The results showed that management plans were revised for the majority of patients, and that 78% of such revisions involved a change in treatment modality. While investigation of the long-term clinical outcomes of these changes in management is warranted, these results indicate that decisions based on 18F fluciclovine PET/CT findings may facilitate appropriate management in men with suspected biochemical recurrence of prostate cancer.”

“Up to 30% of patients with prostate cancer will develop local or distant recurrences within 10 years of radical prostatectomy or radiation therapy and determining the extent and location of recurrent disease optimizes the selection of appropriate treatment,” said Lale Kostakoglu, MD, MPH, Professor of Radiology and Chief of Nuclear Medicine, Icahn School of Medicine at Mount Sinai, New York, NY and member of one of the LOCATE study group’s leading enrollment sites. “The LOCATE study demonstrated that imaging with 18F fluciclovine PET/CT revealed one or more sites of disease recurrence in men with biochemically recurrent prostate cancer who were scanned, and 3 based on the pattern of recurrence, resulted in a change in management after the scan in 59% of the patients.”

About the LOCATE trial

Blue Earth Diagnostics’ investigational LOCATE study (“The Impact of 18F Fluciclovine (FACBC) PET/CT (Positron Emission Computed Tomography) on Management of Patients with Rising PSA (Prostate-specific Antigen) After Initial Prostate Cancer Treatment”), is a U.S. multi-center study investigating the impact of 18F fluciclovine PET/CT imaging on the management of patients with rising PSA after initial prostate cancer treatment. The clinical utility of 18F fluciclovine PET/CT imaging was assessed by the change from initial management recommendation to the treatment plan after scanning with 18F fluciclovine PET/CT. Additional information about the LOCATE trial is available at: www.clinicaltrials.gov (NCT02680041).

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. NOTE: Axumin (fluciclovine F 18) injection is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer.

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 U.S. Axumin prescribing information is available at www.axumin.com.

*This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States. Please be aware that the approval status and product label for Axumin varies by country worldwide. Refer to the individual country product label for complete information or contact Blue Earth Diagnostics.

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

Contact:

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

Media 
Sam Brown Inc. 
Mike Beyer 
(M) (312) 961-2502 
mikebeyer@sambrown.com

For Blue Earth Diagnostics (UK)
Georgina Mowatt
Communications Manager
Tel: +44 (0) 7810 355 912
g.mowatt@blueearthdx.com

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