HAMILTON, ON, June 28, 2022 /PRNewswire/ - The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, has licensed [18F]PSMA-1007 from ABX- advanced biochemical compounds GmbH (Radeberg, Germany) and will hold the exclusive license to manufacture, commercialize and distribute the imaging agent in Canada. Concurrently, CPDC is also pleased to announce that it has entered into a commercial sublicense agreement with Lawson Health Research Institute (Lawson), to utilize [18F]PSMA-1007 as a critically important prostate cancer diagnostic tool for studies involving participants residing in proximity to Lawson in the London, Ontario region.
This commercial sublicensing agreement builds upon CPDC's-sponsored Phase III clinical trial of [18F]PSMA-1007, which began enrolling patients in early 2021 for the diagnosis of recurrent prostate cancer. This positron-emitting tomography (PET) agent targets Prostate Specific Membrane Antigen (PSMA), which is overexpressed in prostate cancer. PSMA is a membrane-bound enzyme with high expression in prostate cancer cells (a predictor for prostate cancer progression) but weakly expressed benign prostatic tissue.1
Prostate cancer is the third leading cause of death from cancer among Canadian men. In 2021, it was estimated that 24,000 Canadian men will be diagnosed with prostate cancer, representing 20% of all new cancer cases. Prostate cancer is also estimated to have caused 4,500 deaths in Canadian men, or 10% of all cancer deaths in 2021 in Canada.2
According to the Johns Hopkins University School of Medicine, around 20-30% of men will relapse after the five-year mark following initial treatment.3 Prostate cancer recurrence following treatment is commonly determined by rising prostate-specific antigen (PSA) levels, which is a protein made by cells in the prostate gland.4 Reports indicate that PSMA-based PET may enable improved primary and metastatic tumour detection rates than the current standard of radiological imaging.1,5 Compared to other PMSA-targeted PET agents, [18F]PSMA-1007 also has the advantage of hepatobiliary excretion, which may improve detection of local recurrence and pelvic lymph node metastases.1,6,7
"We are delighted to strengthen CPDC's partnership with Lawson through this sublicense agreement for [18F]PSMA-1007." said CPDC's CEO, Bruno Paquin. "We believe this partnership will benefit patients in Ontario by providing expanded access to this important diagnostic agent, allowing for better treatment outcomes. As part of CPDC's mission to transform patients' lives by advancing high quality drugs for the diagnosis and treatment of diseases, we hope to increase access of the diagnostic agent to the rest of Canada and nurture additional valued domestic partnerships."
"We are excited that this novel radiopharmaceutical will be produced locally by Lawson's Cyclotron & PET Radiochemistry Facility, located at St. Joseph's Hospital. Clinical trials exploring the impact of this important new imaging agent on the care of men with prostate cancer are underway in London and this local production capacity enhances our ability to offer these trials to more men in our region." said Dr. Glenn Bauman, Radiation Oncologist, London Regional Cancer Program at London Health Sciences Centre and Associate Scientist, Lawson.
"This partnership leverages the strengths of Lawson's cyclotron expertise and production capacity with that of CPDC. As the first sublicensee, access to this prostate cancer imaging tool is a significant milestone for Lawson and southwestern Ontario." said Dr. Michael Kovacs, Director, Cyclotron & PET Radiochemistry, Lawson.
CPDC's Phase 3 clinical trial (CPD-002) is a prospective, single arm, non-randomized, open label study that will enroll 100 men with suspected persistent or recurrent prostate cancer based on detectable levels of prostate serum antigen (PSA) and having negative or equivocal detection of disease by conventional imaging. The primary objective of the clinical trial is to evaluate the diagnostic performance of [18F]PSMA-1007 PET, by comparing the PET imaging results to a composite of clinical outcome information. Other objectives include assessing the safety of [18F]PSMA-1007 and the impact of [18F]PSMA-1007 PET on management of patients with recurrent prostate cancer. For additional information about the clinical trial, visit www.clinicaltrials.gov (NCT04644822).
The Centre for Probe Development and Commercialization (CPDC) is a Centre of Excellence for Commercialization and Research (CECR) located at McMaster University in Hamilton, Ontario, Canada. CPDC is a private, not-for-profit company and global leader in the discovery, development and commercialization of next-generation radiopharmaceuticals that was created with the support of multiple stakeholders, including the Networks of Centres of Excellence (NCE), McMaster University and the Ontario Institute for Cancer Research (OICR). Since its foundation in 2008, CPDC has established a pipeline of products along with a robust and reliable global supply of innovative diagnostic and therapeutic radiopharmaceuticals used daily for the detection and treatment of human diseases such as cancer. For more information about CPDC, please visit: www.imagingprobes.ca or contact email@example.com.
ABX is active in manufacturing and development of cGMP chemicals for nuclear medicine and owns one of the first approved and fully automated industrial-scale production facilities for radioactive theranostics with its own sterile testing. For more information, please visit http://www.abx.de.
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