Bayer: The CHUM Was Ranked First in the World After Using the FAST TRACK Evaluation Service for the First Time
The Bayer pharmaceutical company used the FAST TRACK Evaluation Service for the first time to accelerate the authorization of its PAnTHA advanced prostate cancer trial at the Centre hospitalier de l’Université de Montréal (CHUM) in 10.4 weeks, with site activation in 12.2 weeks. The CHUM positioned itself as the first site activated worldwide and also recruited the first patient globally.
“Bayer Canada is very fortunate to have collaborated with CATALIS to achieve first patient first visit globally for this important study at Dr. Fred Saad’s site in Montreal. With CATALIS and the CHUM, we were able to showcase the speed with which we can activate studies in Quebec, and ultimately deliver novel radiopharmaceutical medicines to patients with urgency. Bayer considers CATALIS an integral partner in helping us efficiently advance our assets through the clinical development phases and offer novel treatment options to Canadian patients.” – Alison Batty, Head Site Management Canada, Bayer
With this Phase I trial, Bayer hopes to find a better way to treat people with mRCC, an advanced prostate cancer that has spread to other parts of the body and does not respond to metastatic castration, which is the hormonal treatment usually used to lower testosterone level and prevent cancer growth. The PAnTHA study aims to assess the safety, tolerance, pharmacokinetics, and preliminary efficacy of 225Ac-PSMA-Trillium, a targeted alpha therapy that is a new class of agents currently in clinical development.
The trial aims to recruit 34 patients, including 7 in Quebec.
“As one of CATALIS’ three founding partner institutions, the CRCHUM is extremely proud to participate in the FAST TRACK Evaluation Service and thus offer patients with metastatic prostate cancer quick access to this promising new therapeutic modality within the framework of this project led by Professor Saad.”– Dr. Vincent Poitout, Director of Research and Innovation, CHUM, Scientific Director, CRCHUM (CHUM Research Centre), Full Professor, Department of Medicine, Université de Montréal
“We are very proud to have been able to activate this Phase 1 study in record time, particularly given the complexity of a clinical trial assessing a new agent targeting advanced prostate cancer. This new treatment gives hope to patients who have exhausted virtually all available therapeutic options to prolong their lives. We are extremely grateful that one of our patients is the first in the world to benefit from this clinical trial and hope this treatment will prove effective in managing this life-threatening stage of the disease. We thank the patients and their caregivers who are willing to participate in clinical trials because it is the only way to offer new treatment options to patients around the world.” – Dr. Fred Saad Director, Prostate Cancer Research, Montreal Cancer Institute, CRCHUM, Uro-Oncologist, Urology Department, CHUM, Full Professor, Department of Surgery, Université de Montréal
Should you want more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
