BriaCell Makes Progress with UCLA Health in Phase 3 Study
BriaCell Partners with UCLA Health for Breast Cancer Study
BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW, BCTXZ) (TSX: BCT), a pioneering clinical-stage biotechnology company, is excited to announce that it has welcomed the renowned UCLA Health Jonsson Comprehensive Cancer Center into its pivotal Phase 3 clinical study. This important trial focuses on evaluating Bria-IMT™, a novel immunotherapy, in conjunction with a checkpoint inhibitor as compared to the physician’s choice of treatment for patients facing advanced metastatic breast cancer (MBC).
Encouragement from the Medical Community
Dr. Kelly E. McCann, a respected Breast Medical Oncologist and Lead Investigator at UCLA Health, expressed optimism regarding the potential outcomes of the Phase 3 study. He emphasized the promising randomized Phase 2 data associated with the Bria-IMT combination, highlighting its significance in seeking to enhance survival outcomes for patients battling metastatic breast cancer. “The addition of our esteemed center to this trial aligns perfectly with our goal to deliver cutting-edge cancer care,” he stated.
Trial Design and Goals
This ongoing study, dubbed Bria-ABC, will undertake an interim analysis after 144 patient deaths have occurred. The primary endpoint will focus on overall survival (OS), comparing the efficacy of the Bria-IMT combination with a checkpoint inhibitor against the standard physician's choice. The structure of this trial builds on the encouraging survival data received from the previous Phase 2 study, details of which were recently showcased.
Impact of FDA Fast Track Designation
Significantly, the Bria-IMT combination regimen has secured Fast Track designation from the FDA, a recognition marking its potential to address a serious unmet medical need in the treatment of MBC. This designation serves as an acknowledgment of the urgency and necessity for innovative treatments in this area of oncology.
Collaborating with Top-Tier Institutions
Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer, discussed the importance of collaboration with esteemed institutions like UCLA Health. “Partnering with top-tier cancer centers significantly boosts our capacity for robust trial enrollment and efficient execution,” he noted. BriaCell is confident in its ability to share top-line data from this pivotal Phase 3 study by 2026, marking a significant milestone for the company.
Participation Details and Further Information
For those interested in learning more about the specifics of BriaCell’s pivotal Phase 3 clinical study, including how to participate or what the trial entails, more details can be accessed through ClinicalTrials.gov at NCT06072612.
About BriaCell Therapeutics Corp.
BriaCell is dedicated to transforming cancer treatment through innovative immunotherapy solutions. This commitment positions them as a leader in clinical-stage biotechnology. For further insights into the company’s mission and ongoing projects, visit https://briacell.com/.
Frequently Asked Questions
What is the purpose of the Phase 3 study mentioned?
The Phase 3 study aims to evaluate the effectiveness of Bria-IMT in combination with a checkpoint inhibitor compared to physician’s choice treatment for metastatic breast cancer patients.
Why is UCLA Health involved in this study?
UCLA Health is a recognized leader in cancer care and adds credibility and support to the ongoing study, facilitating patient enrollment and trial execution.
What does FDA Fast Track designation mean for Bria-IMT?
Fast Track designation indicates that the Bria-IMT combination has the potential to meet a significant unmet medical need, allowing for expedited review and development processes.
When are the top-line data results expected?
BriaCell anticipates sharing the top-line data results from the Phase 3 study by 2026, marking a significant upcoming milestone for the company.
How can I find more information about participating in the trial?
For more information on the trial and participation details, please visit ClinicalTrials.gov and search for identifier NCT06072612.
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