CPDC Announces Closure of Phase 3 Clinical Trial of [18F]PSMA-1007 Prostate Cancer Diagnostic Imaging Agent
Significant Milestone on the Path to Submission for Canadian Regulatory Approval in Late 2024
HAMILTON, ON, March 13, 2024 – The Centre for Probe Development and Commercialization (CPDC), a global leader in the development and commercialization of radiopharmaceuticals, today announced the closure of the Canadian Phase 3 trial for [18F]PSMA-1007. [18F]PSMA-1007 is a positron-emitting tomography (PET) diagnostic imaging agent that targets Prostate Specific Membrane Antigen (PSMA), a protein that is overexpressed in prostate cancer.
“With low uptake in the bladder, [18F]PSMA-1007 is expected to provide improved lesion identification in the pelvic region, a potentially important clinical advancement in detecting early-stage prostate cancer. We look forward to submitting the trial results to Health Canada later this year,” said Owen Roberts, CEO of CPDC. “We are grateful for the patients who participated in the trial and the dedication of the study investigators.”
“The Phase 3 clinical trial of [18F]PSMA-1007 is an excellent collaboration between London Regional Cancer Program, Lawson’s Cyclotron & PET Radiochemistry Facility at St. Joseph’s Hospital, and the University Health Network,” said Dr. Glenn Bauman, Radiation Oncologist, London Regional Cancer Program at London Health Sciences Centre and Associate Scientist, Lawson. “We are excited by the potential benefit of this novel diagnostic imaging agent on the lives of Canadian prostate cancer patients.”
“With low uptake in the bladder, [18F]PSMA-1007 is expected to provide improved lesion identification in the pelvic region, a potentially important clinical advancement in detecting early-stage prostate cancer. We look forward to submitting the trial results to Health Canada later this year,” said Owen Roberts, CEO of CPDC. “We are grateful for the patients who participated in the trial and the dedication of the study investigators.”
“The Phase 3 clinical trial of [18F]PSMA-1007 is an excellent collaboration between London Regional Cancer Program, Lawson’s Cyclotron & PET Radiochemistry Facility at St. Joseph’s Hospital, and the University Health Network,” said Dr. Glenn Bauman, Radiation Oncologist, London Regional Cancer Program at London Health Sciences Centre and Associate Scientist, Lawson. “We are excited by the potential benefit of this novel diagnostic imaging agent on the lives of Canadian prostate cancer patients.”
About [18F]PSMA-1007
[18F]PSMA-1007 is a positron emission tomography (PET) imaging agent that binds to PSMA. Published clinical data suggest that [18F]PSMA-1007 PET has the potential to improve the detection of recurrent prostate cancer with earlier detection and better localization of disease, thereby improving patient management. In addition, the lipophilic characteristics and hepatobiliary excretion of [18F]PSMA-1007 allow for improved imaging of local recurrence and pelvic lymph node metastases in the prostatic bed versus other [18F]PSMA-targeting agents. CPDC has licensed [18F]PSMA-1007 from ABX – advanced biochemical compounds GmbH (Radeberg, Germany) and holds the exclusive license to develop, manufacture, and distribute the imaging agent in Canada.
About the Phase 3 Clinical Trial of [18F]PSMA-1007
The Phase 3 clinical trial is a prospective, single arm, non-randomized, open label study that enrolled 100 men with suspected persistent or recurrent prostate cancer based on detectable levels of prostate serum antigen (PSA) and had 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. While enrollment is now closed, additional information on the trial can be found at www.clinicaltrials.gov (NCT NCT04644822).
About CPDC
CPDC is a not-for-profit corporation founded in 2008 to advance probe (chemical agents that will carry medical isotopes to targets in the body) discovery, development, and clinical research, and provide a reliable supply of radiopharmaceuticals. CPDC’s mission is to improve the quality of Canadian patients’ lives through the commercialization of advanced research and the clinical development of nuclear medicine. In the past 15 years, CPDC has created four Canadian commercial entities that have advanced the availability of radiopharmaceuticals to the Canadian medical community. CPDC’s self-funding business model will continue to identify and advance critical radiopharmaceuticals to meet the needs of Canadian patients and physicians through collaboration with partners including industry, academia, and government. For more information on CPDC, visit www.cpdc.ca and follow on LinkedIn.
Contact:
Owen Roberts, CEO, CPDC: owen@cpdc.ca
Contact:
Owen Roberts, CEO, CPDC: owen@cpdc.ca
