- BriaCell (BCT) Phase II meeting comes to a positive end with the FDA for Bria-IMT™ Combination in Advanced Metastatic Breast Cancer
- After the meeting, the FDA agreed on the primary endpoint of the pivotal registration study design and the type of patients to be included
- Registration study success could lead to commercialization approvals for BriaCell’s novel immunotherapy approach
- BriaCell is an immuno-oncology-focused biotechnology company developing targeted and practical approaches for cancer management
- BriaCell Therapeutics (BCT) is down 3.44 per cent, trading at C$8.98 at 11:43 am EST
BriaCell Therapeutics (BCT) received agreement and positive feedback from its End of Phase II meeting with the FDA.
The meeting was regarding BriaCell’s lead clinical candidate, Bria-IMT, in advanced metastatic breast cancer.
BriaCell and the FDA have agreed on the primary endpoint and the type of patients enrolled in BriaCell’s upcoming pivotal clinical study.
This registration study will focus on enrolling advanced metastatic breast cancer patients with no approved treatment options.
Registration study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.
“The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies,” stated Dr. William V. Williams, BriaCell’s President and CEO.
“Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options,” added Williams.
BriaCell Therapeutics (BCT) is down 3.44 per cent, trading at C$8.98 at 11:43 am EST.