Blue Earth Diagnostics’ Initial Results From FALCON Trial Show 61% Of Patients With Suspected Recurrent Prostate Cancer Had Treatment Plan Changed Following Fluciclovine (18F) PET/CT Scan

BURLINGTON, Mass. & OXFORD, England--(BUSINESS WIRE)--Blue Earth Diagnostics, a molecular imaging diagnostics company, today announced the results of a pre-planned interim analysis from an investigational clinical trial (“FALCON”) evaluating the impact of fluciclovine (¹⁸F) PET/CT imaging on the clinical management of men with biochemically recurrent prostate cancer eligible for salvage therapy. The FALCON trial is a UK-based, prospective, multi-centre, open-label study (NCT02578940) to evaluate the clinical impact of fluciclovine (¹⁸F) PET/CT imaging on patient management decisions in men with biochemically recurrent prostate cancer. The primary endpoint of the FALCON study examines the percentage of men who have their management plan changed after a fluciclovine (¹⁸F) PET/CT scan. Blue Earth Diagnostics previously announced a halt to patient recruitment for the trial based on successful results of a pre-planned interim analysis.

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. It is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer. (For additional product information please see the end of this News Release.)

The FALCON trial recorded intended patient management plans prior to fluciclovine (¹⁸F) PET/CT and then recorded how they were altered once patients and their clinicians had results of the scan. Results of the interim analysis showed that 61.2% (52/85) of patients had their clinical management changed when results of fluciclovine (¹⁸F) PET/CT imaging were added to the standard-of-care diagnostic work-up. The interim results were presented in an oral presentation, “Impact of ¹⁸F-fluciclovine PET/CT on clinical management of patients with recurrent prostate cancer: results from the Phase III FALCON trial,” by Eugene Teoh, MD, Oxford University Hospitals NHS Foundation Trust, at the 2017 American Society for Radiology Oncology (ASTRO) Annual Meeting, September 24 – 27, 2017.

The FALCON trial enrolled men with a biochemical recurrence of prostate cancer being considered for curative intent salvage therapy. Intended management plans were recorded prior to fluciclovine (¹⁸F) PET/CT imaging and then compared with post-scan plans. The primary endpoint examined the percentage of men who had their management plan changed after a fluciclovine (¹⁸F) scan. A single, pre-planned analysis of the primary endpoint for efficacy or futility was performed based on the first 85 evaluable patients. Based on this analysis, recruitment in the trial was stopped for efficacy. Previously planned therapeutic management was revised after a fluciclovine (¹⁸F) PET/CT scan in 61.2% (52/85) of patients. Of the 52 patients with revised treatment plans, major revisions (e.g., salvage radiotherapy to hormone deprivation or watchful waiting) were made for 59.6% (31/52) of patients. Salvage treatment was revised to watchful waiting for 25.0% (13/52) patients and to systemic therapy for 34.6% (18/52) patients, while 40.4% (21/52) patients had their previously planned radiotherapy field modified. The safety profile of fluciclovine (¹⁸F) in the FALCON trial is consistent with that described in the approved U.S. Prescribing Information.

“We are very pleased to share these initial results from the FALCON study with the radiation oncology community at ASTRO,” said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. “In line with our mission to develop and commercialize innovative PET imaging agents for cancer, the FALCON study was designed to assess the utility of a fluciclovine (¹⁸F) PET/CT scan in providing meaningful information for physicians, with the hope that it may benefit men with recurrent prostate cancer. We look forward to announcing full results of the FALCON study in a future peer-reviewed publication.”

“Biochemically recurrent prostate cancer poses an important medical challenge,” said Abhishek Solanki, MD, Assistant Professor of Radiation Oncology, Loyola University School of Medicine, Chicago, Ill. “Currently approved anatomical imaging procedures have limitations in identifying the sites of recurrence of prostate cancer after definitive treatment, which can make decision-making difficult when assessing patients with biochemical recurrence. Newer imaging techniques, such as fluciclovine (¹⁸F) PET/CT, may provide actionable information for physicians in guiding appropriate patient management.”

“Selecting appropriate patient care options for men with biochemically recurrent prostate cancer is critical,” said Judd Moul, MD, Professor of Surgery, Urology, at Duke University. “Many options are available, and some patient management plans may carry uncertainty that could potentially be alleviated by more accurate information. Clinical studies are important to investigate the role that reliable information provided by diagnostic imaging can play in guiding appropriate management for men with recurrent prostate cancer.”

Blue Earth Diagnostics has also updated the status of its 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”), which completed patient enrollment earlier than anticipated. Compilation of data from the 15 clinical sites is currently underway, with results planned for peer-reviewed presentation and publication next year. The LOCATE trial is a U.S. multi-center study investigating the impact on patient management of ¹⁸F fluciclovine PET/CT imaging in patients with rising PSA after initial prostate cancer treatment. The clinical utility of ¹⁸F fluciclovine PET/CT imaging will be assessed by the change from initial to revised treatment plan. Additional information about the LOCATE trial is available at: www.clinicaltrials.gov (NCT02680041).

About the FALCON Trial

The FALCON trial, “Fluciclovine (¹⁸F) PET/CT in biochemicAL reCurrence Of prostate caNcer (FALCON),” is an open-label multi-center study in the U.K. designed to assess the clinical utility of fluciclovine (¹⁸F) PET imaging in the management of patients with prostate cancer with biochemical recurrence after initial treatment. The primary endpoint is to evaluate the clinical impact of fluciclovine (¹⁸F) in affecting treatment decision and is assessed by comparing records of the patient’s treatment plan after a fluciclovine (¹⁸F) PET scan with the treatment plan prior to the scan. Secondary endpoints include evaluation of the effect of treatment change in patients with positive fluciclovine (¹⁸F) PET imaging findings who had a treatment change involving radical salvage therapy; diagnostic performance; PSA threshold; safety assessment and comparison with choline PET (if performed).

The FALCON trial is jointly funded by Innovate UK and Blue Earth Diagnostics and is being conducted at six leading institutions in the UK: Oxford University Hospitals NHS Foundation Trust, University College London, Kings College London, The Royal Marsden NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Mount Vernon Cancer Centre and Greater Glasgow Health Board. Additional information about the FALCON trial is available at: www.clinicaltrials.gov (NCT02578940).

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