News | PET Imaging | November 25, 2020

Blue Earth Diagnostics Announces First Patient Doses of PET Imaging Agent in Collaboration with Nucleis Radiopharmaceuticals

 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced that their manufacturing partner Nucleis (Liege, Belgium) has manufactured and shipped their first patient doses of rhPSMA-7.3 (18F), an investigational Prostate-Specific Membrane Antigen (PSMA)-targeted radiohybrid PET imaging agent, currently under evaluation in clinical trials in men with newly diagnosed prostate cancer and suspected prostate cancer recurrence.

November 25, 2020 — Blue Earth Diagnostics, a leading molecular imaging diagnostics company, today announced that their manufacturing partner Nucleis (Liege, Belgium) has manufactured and shipped their first patient doses of rhPSMA-7.3 (18F), an investigational Prostate-Specific Membrane Antigen (PSMA)-targeted radiohybrid PET imaging agent, currently under evaluation in clinical trials in men with newly diagnosed prostate cancer and suspected prostate cancer recurrence.

Prostate cancer is a leading cause of cancer death in men. Accurate staging of newly diagnosed prostate cancer assists in directing appropriate initial treatment strategies. After initial treatment, recurrence occurs in up to one-third of patients, typically detected by a rise in prostate-specific antigen (PSA) levels. However, in both settings, conventional imaging is limited in detecting the location and extent of the disease. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer.

Blue Earth Diagnostics has been working closely with Nucleis Radiopharmaceuticals, formerly part of the Cyclotron Research Centre (University of Liege in Belgium), to establish them as a contract manufacturer able to supply clinical trial sites. Nucleis is now qualified to supply rhPSMA-7.3 (18F) as part of a clinical trials programme in the Netherlands where the first patients have been scanned.

Blue Earth Diagnostics has two Phase 3 studies underway to investigate the use of rhPSMA-7.3 (18F) PET imaging in prostate cancer. The SPOTLIGHT study is designed to evaluate its safety and diagnostic performance in men with suspected prostate cancer recurrence based on elevated PSA following prior therapy. The LIGHTHOUSE trial is designed to evaluate the safety and diagnostic performance of rhPSMA-7.3 (18F) PET imaging in men with newly diagnosed prostate cancer. Further information, including a current list of clinical trial sites, can be found on www.clinicaltrials.gov (LIGHTHOUSE at NCT04186819, and SPOTLIGHT at NCT04186845).

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, “Our collaboration with Nucleis Radiopharmaceuticals and supply of our first rhPSMA-7.3 (18F) doses from their site in Liege is a great development in our R&D programme. This will enable us to bring more European sites into our clinical trials programme as part of our work to bring new products to clinicians and their patients.”

Fabrice Giacomelli, Chief Executive Officer of Nucleis Radiopharmaceuticals said, “We are pleased to have been chosen by a global leader in diagnostic imaging, Blue Earth Diagnostics, to manufacture and supply rhPSMA-7.3 (18F) doses for these two Phase 3 studies. This collaboration is fully aligned with the Nucleis mission of delivering innovative PET tracers and improving patient care.”

About rhPSMA

rhPSMA-7.3 (18F) is an investigational agent that consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilised clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

For more information: www.blueearthdiagnostics.com

Related Content

MRI Targeted biopsy is performed using cognitive fusion more easily with anatomical guidance based on the radiology report. MRI targets can be identified quickly in real-time along with micro-ultrasound targets, which may have been missed on MRI.

MRI Targeted biopsy is performed using cognitive fusion more easily with anatomical guidance based on the radiology report. MRI targets can be identified quickly in real-time along with micro-ultrasound targets, which may have been missed on MRI. Image courtesy of Exact Imaging

Feature | Prostate Cancer | January 20, 2021 | By Brian Wodlinger, Ph.D.
Historically when a patient had an elevated PSA (prostate specific antigen) test their urologist would take the next
The exceptionally high dose rate of the FLASH Beam is 3,000 times higher than normal therapy treatment (300 Gray per second vs. 0.1 Gray per second, Gray being a standard unit measuring absorbed radiation). Instead of treatment over 20 seconds, an entire treatment is completed in 6 milliseconds, giving the therapy its nickname, "FLASH." Image courtesy of Brian Pogue, PhD

The exceptionally high dose rate of the FLASH Beam is 3,000 times higher than normal therapy treatment (300 Gray per second vs. 0.1 Gray per second, Gray being a standard unit measuring absorbed radiation). Instead of treatment over 20 seconds, an entire treatment is completed in 6 milliseconds, giving the therapy its nickname, "FLASH." Image courtesy of Brian Pogue, PhD

News | Linear Accelerators | January 20, 2021
January 20, 2021 — A joint team of researchers from Radiation Oncology at Dartmouth's and...
Novel Coronavirus SARS-CoV-2 Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: National Institute of Allergy and Infectious Diseases, NIH

Novel Coronavirus SARS-CoV-2 Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Image courtesy of  National Institute of Allergy and Infectious Diseases (NIH)

News | Coronavirus (COVID-19) | January 15, 2021
January 15, 2021 — In one of the first studies to examine the impact of the...
The "US Prostate Cancer Nuclear Medicine Diagnostics Market to 2027 - Country Analysis and Forecast by Type; PET Product" report has been added to ResearchAndMarkets.com's offering. The prostate cancer nuclear medicine diagnostics market in the US was valued at $194.47M in 2019 and is expected to grow at a CAGR of 10.6% from 2020 to 2027 to reach $431.76M by 2027.

Getty Images

News | Prostate Cancer | January 13, 2021
January 13, 2021 — The ...
A study led by researchers at the UCLA Jonsson Comprehensive Cancer Center has found that magnetic resonance imaging, or MRI, frequently underestimates the size of prostate tumors, potentially leading to undertreatment.

A study led by researchers at the UCLA Jonsson Comprehensive Cancer Center has found that magnetic resonance imaging, or MRI, frequently underestimates the size of prostate tumors, potentially leading to undertreatment.

News | Prostate Cancer | January 11, 2021
January 11, 2021 — A study
Mirion Technologies, Inc., a global provider of innovative radiation detection and measurement solutions, announced that it has acquired Sun Nuclear Corporation. Sun Nuclear is the global leader in radiation oncology quality assurance, delivering patient safety solutions for diagnostic imaging and radiation therapy centers around the world.
News | Quality Assurance (QA) | January 08, 2021
January 8, 2021 — Mirion Technologies, Inc., a global provider of
RAD Technology Medical Systems (RAD) announced it is expanding its portfolio of patented modular healthcare solutions in 2021 with the introduction of a compact shielding facility designed to accommodate the latest models of low energy, self-shielded linear accelerators (linacs) that are now available worldwide. 

Image courtesy of Siemens Healthineers

News | Linear Accelerators | January 04, 2021
January 4, 2021 — RAD Technology Medical Systems (RAD) ann