Advaxis (ADXS) jumps 14% after the company says it plans to start enrollment this fall of a Phase 2 clinical study of its lead investigational Lm Technology immunotherapy, axalimogene filolisbac (ADXS-HPV), in metastatic anal cancer. The study is to be called FAWCETT (Fighting Anal-Cancer with CTL Enhancing Tumor Therapy) and will be the company’s second Phase 2 study of axalimogene filolisbac in anal cancer.
The two-part, single-arm, open-label study is designed to evaluate the efficacy and safety of axalimogene filolisbac as monotherapy in patients with human papillomavirus (HPV)-associated metastatic anal cancer who have received at least one prior treatment regimen for advanced disease.
The FAWCETT study will enroll approximately 31 patients in Part A and approximately 24 patients in Part B. The primary efficacy endpoints include overall response rate and progression-free survival, and the secondary endpoints include evaluation of overall response rate and the safety/tolerability of the dose.
Companies: Advaxis, Inc.
Price: 15.80 Price Change: +1.94 Percent Change: +14.00