CPDC Announces First Patient Dosed in a Phase 3 Clinical Trial of a Prostate Cancer Diagnostic Imaging Product, [18F]PSMA-1007

February 24, 2021 CPDC

Hamilton, Ontario, February 24, 2021 – The Centre for Probe Development and Commercialization (CPDC), a global leader in the development, production and commercialization of radiopharmaceuticals, is announcing today that the first patient has been dosed and imaged in a Phase 3 trial for [18F]PSMA-1007. This diagnostic imaging product is a positron-emitting tomography (PET) agent that targets Prostate Specific Membrane Antigen (PSMA), a protein that is overexpressed in prostate cancer.

Prostate cancer is the most common malignancy in Canadian men, accounting for over 23,000 new cases per year and 4,000 deaths annually. Men with recurrent or persistent prostate cancer have poor outcomes, and there is an unmet need to accurately define the location and overall spread of disease in this population to help plan effective treatment.

“We are excited to bring [18F]PSMA-1007 to Canadian patients as we believe that improved detection of disease in the pelvic region and areas of metastases by [18F]PSMA-1007 will lead to better outcomes in prostate cancer patient treatments.” said CPDC’s Interim CEO, Bruno Paquin. “We also express our appreciation to Drs. Joseph Chin (Professor of Urology and Oncology at Western University), Glenn Bauman (Chair/Chief, Cancer Care, London Health Sciences Centre), and Ur Metser (Division Head Molecular Imaging, Joint Department Of Medical Imaging at UHN) for their contributions to this program and look forward to working with them as investigators in this trial”.

“Imaging prostate cancer with PET imaging agents directed towards PSMA is an extremely exciting advance for the personalized care of men with prostate cancer. This Phase III trial will be crucial in providing information regarding the safety and accuracy of [18F]PSMA-1007 PET imaging and will pave the way to establishing this type of imaging as an approved standard of care imaging test in Canada for men with prostate cancer.” said Dr. Glenn Bauman

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 Clinical Trial

The Phase 3 clinical trial 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-1007and 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).

About Centre for Probe Development and Commercialization (CPDC)

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 info@imagingprobes.ca

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