Blue Earth announces results from initial clinical experience of PSMA
07 May 2019
Syncona Ltd, a leading healthcare company focused on founding, building and funding global leaders in life science, is pleased to note that its portfolio company, Blue Earth Diagnostics (Blue Earth), has announced results from early clinical experience in an academic setting with its radiohybrid PSMA-targeted agent, rhPSMA-7 in high-risk primary and recurrent prostate cancer. Blue Earth acquired rhPSMA-7 in 2018 to extend its leading position in prostate cancer imaging, including potential new areas of high unmet need, such as early stage primary prostate cancer patients.
The Technical University at Munich (TUM) has utilised the agent in early clinical experience in men with both primary and recurrent cancer. These retrospective analyses were presented at the Annual Urological Association's 2019 Annual meeting:
· A retrospective analysis of 58 patients with high risk primary prostate cancer indicated that 18F-rhPSMA-7 PET/CT demonstrated sensitivity of 72% (13/18), specificity of 93% (37/40) and diagnostic accuracy 86% (50/58), when compared to histopathological findings.
· A retrospective analysis of 261 patients with biochemically recurrent prostate cancer in which 18F-rhPSMA-7 PET/CT demonstrated a detection rate of 81% (211/261) at a median PSA level of 0.96 ng/mL
Blue Earth expects to launch its own phase I/II clinical trial in 2019 calendar year.
Martin Murphy, Chief Executive of Syncona Investment Management Limited, said: "We are encouraged by these results, which provide further evidence to support the potential clinical utility of rhPSMA-7 in both high-risk primary and recurrent prostate cancer. While Blue Earth will next look to test this hypothesis in its own clinical trial, this data reinforces our belief that this PSMA agent is one of the leading assets in the space and should enable Blue Earth to extend its leading position in prostate cancer diagnostics."
Blue Earth Chief Executive, Jonathan Allis, said: "We are very pleased that TUM is able to share the results of this initial clinical experience with the prestigious urology community at AUA 2019. Blue Earth Diagnostics acquired rhPSMA-7 last year as part of our mission to develop and commercialize innovative PET imaging agents for cancer. rhPSMA-7 is a strategic expansion of our technologically advanced imaging portfolio, and a complement to approved, commercially available Axumin."
Syncona has an 89.0 per cent stake in the business with a holding value of £229.6 million.
Siobhan Weaver / Annabel Clay
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Brett Pollard / Ben Atwell / Natalie Garland-Collins
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Syncona is a leading FTSE250 healthcare company focused on founding, building and funding global leaders in life science. Our vision is to deliver transformational treatments to patients in truly innovative areas of healthcare while generating superior returns for shareholders.
We seek to partner with the best, brightest and most ambitious minds in science to build globally competitive businesses.
We take a long-term view, underpinned by a deep pool of capital, and are established leaders in gene and cell therapy. We focus on delivering dramatic efficacy for patients in areas of high unmet need.
About Blue Earth Diagnostics
Blue Earth Diagnostics is a molecular imaging diagnostics company focused on the development and commercialisation 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 recognised experts in the clinical development and commercialisation of innovative nuclear medicine products.
Blue Earth Diagnostics' first approved and commercially available product is Axumin® (fluciclovine 18F), a novel molecular imaging agent approved in the United States and Europe 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.blueearthdx.com.
rhPSMA-7 was invented at the Technical University of Munich, Germany, where it has been utilized clinically in the diagnostic imaging of men with both primary and recurrent prostate cancer. 18F-rhPSMA-7 consists of a prostate-specific membrane antigen (PSMA) receptor ligand, which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA-7 and other "rh" compounds, can also be labeled with the radioisotope 177Lu for therapeutic use.
Scintomics' unique theranostic "rh" technology allows for the efficient labelling of PSMA-targeted agents with imaging radioisotopes, such as 18F or 68Ga, or therapeutic radioisotopes such as 177Lu. Depending on the type of radioisotope attached, the resulting radiopharmaceutical may be used either as an imaging agent to locate prostate cancer cells in the body or as a therapeutic which targets cancer cells with high energy radiation. These innovative compounds offer the possibility of "precision medicine" for men with prostate cancer.
 This early clinical experience with rhPSMA-7 by TUM in Germany reflects use of an investigational agent for which safety and efficacy have not been established by the FDA
 As at 31 December 2018
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