GSK Authorized 3 First Trials With a Median Time of 8.4 Weeks and Activated the First Site Globally
Thanks to CATALIS’ FAST TRACK Evaluation Service and its participating healthcare institutions, the GlaxoSmithKline Inc. (GSK) pharmaceutical company was able to accelerate the authorization of three clinical trials, with a record median time of 8.4 weeks.
The Galaxies 202 trial, which assessed the use of a new combination of treatments for head and neck cancer, was authorized at the Jewish General Hospital (JGH) in 8.8 weeks thanks to the FAST TRACK Evaluation Service. The JGH was the first site to be activated in the world.
The AZUR-2 trial, which tested a new treatment for colon cancer, was authorized at the Research Institute of the McGill University Health Centre (RI-MUHC) in 8 weeks, ranking it as the 2nd site activated in the world.
The INSIGHT trial, which involved an experimental treatment for HIV-1, was authorized at the Centre hospitalier universitaire de Québec (CHUQc) in 7.6 weeks and at the RI-MUHC in 9.4 weeks, ranking them as the co-second sites activated in Canada. The RI-MUHC was also the first Canadian site to recruit a patient for this trial.
“We highly value our partnership with CATALIS as we work together towards our common goal of accelerating clinical trials, ultimately leading to quicker access to medicines and vaccines for those who need them. Through the implementation of FAST TRACK, we have successfully streamlined our clinical trial start-up timelines across numerous Québec-based institutions. This achievement not only positions Québec as an attractive destination for clinical research, contributing to healthcare innovation in a highly competitive global landscape, but it also underscores GSK’s commitment to improving patient outcomes and advancing medical progress.” – Sridhar Venkatesh, President & General Manager at GSK Canada
Galaxies 202 Trial on Head and Neck Cancer
Phase ll of GSK’s Galaxies 202 trial is testing new combinations of immunotherapy as a first-line treatment in people living with recurrent or metastatic squamous cell carcinoma of the head and the neck. It will assess dostarlimab, belrestotug, and GSK6097608.
With this study, GSK seeks to prove that this combination of drugs can improve the action and effectiveness of antitumor cells, such as T-cells. As such, this therapeutic approach could help to activate the immune system by blocking resistance mechanisms or complementing the antitumor activity of immune cells, thus helping to halt or even reduce a tumour’s progression. The Galaxies 202 study hopes to provide significant clinical benefits for head and neck cancer patients, or even offer them an alternative to chemotherapy.
The trial is taking place in 125 sites in 21 countries and aims to recruit 240 patients worldwide.
“The Jewish General Hospital is proud to be the first activated site of the Galaxies 202 trial, thanks to CATALIS’ FAST TRACK Evaluation Service. The rapid authorization of this trial not only highlights the expertise of Dr. Esfahani and the research teams at our institution, but also offers head and neck cancer patients the hope of faster access to an innovative potential treatment.” – Dr. Wilson Miller, Director, Clinical Research Unit, Lady Davis Institute, Jewish General Hospital
“The Galaxies 202 trial is important because it represents the possibility of a treatment consisting of new immunotherapy combinations that are less invasive than chemotherapy for patients with head and neck cancer. The collaboration that enabled the rapid activation of this trial through CATALIS’ FAST TRACK Evaluation Service could bring significant and rapid clinical benefits to patients. This is a source of great satisfaction for our teams.” – Dr. Khashayar Esfahani, Researcher, Lady Davis Institute, Jewish General Hospital, Principal Investigator of the Galaxies 202 trial
AZUR-2 Trial on Colon Cancer
Colon cancer is the third most common type of cancer in the world and is often treated with both chemotherapy and surgery. In contrast, dMMR/MSI-H gastrointestinal cancers generally respond less well to chemotherapy than other types of colon cancers.
Therefore, the purpose of GSK’s AZUR-2 study is to assess the perioperative administration of dostarlimab in monotherapy in patients with this type of advanced colon cancer, relative to the standard of care treatment. Dostarlimab is already approved for the treatment of various cancers, and recent promising results suggest that it may also be of significant benefit to patients with dMMR/MSI-H cancer.
The trial is taking place in 250 sites in 26 countries. It aims to recruit 711 patients worldwide.
“This clinical trial has the potential to radically transform the therapeutic approach for colon cancer patients. We are proud to participate in this study and to offer hope to those facing these difficult diagnoses. We express our sincere gratitude to the patients, healthcare professionals and research staff for their continued dedication and support in advancing medical research and patient care.” – Dr. Jamil Asselah, Researcher, Cancer Research Program, Principal Investigator of the AZUR-2 trial at the RI-MUHC.
“Having access to innovative new clinical trials is essential for all cancer patients. When clinical trials are launched quickly, they offer patients the opportunity to try treatments that can improve their quality of life and extend their survival. The AZUR trials offer new hope to patients with advanced colorectal cancer.” – Barry Stein, President, Colorectal Cancer Canada
INSIGHT Trial on HIV-1
This Phase ll trial’s objective is to assess the antiviral effect, safety, tolerability, and pharmacokinetics of VH452184, an experimental drug, in adults infected with HIV-1 who have not been previously treated.
Currently, antiretroviral therapy uses a combination of at least two drugs, which must be taken daily. With this study, GSK hopes to offer patients the opportunity to benefit from a less invasive treatment which can be administered less frequently.
The clinical trial is taking place in 27 sites in 6 countries around the world. Of the 28 patients taking part, 3 will be in Quebec.
“Our participation in an HIV trial has gained invaluable momentum thanks to the fast turnaround times provided by CATALIS’ FAST TRACK Evaluation Service. Their efficient review processes with our local research ethics boards and contracting teams ensure that innovative treatments reach those in need quickly, providing renewed optimism in the fight against HIV/AIDS”. – Dr. Cecilia Costiniuk, Scientist, Global Health Infectious Diseases and Immunity Program, Principal Investigator of the INSIGHT trial at the RI-MUHC
“The CHU de Québec is a proud partner of the CATALIS FAST TRACK Evaluation Service. Every trial made available to the Quebec population is a further step towards improving our health and living conditions. Dr. Vachon and her team are delighted to be able to take advantage of this innovative service, so as to provide rapid access to new treatments for people living with HIV.” – Dr. Serge Rivest, director of the CHU de Québec-Université Laval’s research centre
Should you want more information about the FAST TRACK Evaluation Service, please write to us at: info@catalisquebec.com.
