Sorry, on the road so can't do much research but I think the PI trial was the Brown study, "This non-randomized, open-label, multi-center study will evaluate the safety and effectiveness of ADXS-HPV when combined with standard chemotherapy and radiation treatment for anal cancer. The primary objectives of the trial include the evaluation of adverse events and the evaluation of 6-month clinical response."
•11 patients enrolled; continuing to track 9 patients who completed
treatment and achieved complete responses
•No further enrollment given Phase 3 study plans
Then came the FAWCETT study, "The multi-center, open-label, two-stage study is designed to evaluate the efficacy and safety of AXAL as a monotherapy in patients with HPV-associated metastatic anal cancer who have received at least one prior treatment regimen for the advanced disease. Stage 1 of the trial will enroll 31 patients with anal cancer whose disease recurred after receiving treatment. Patients will receive AXAL 1x109 colony forming unit (CFU) doses every three weeks for up to two years."
I can't seem t find the FAWCETT trial in the clinicaltrial.gov page but I think both PI and PII trials were not recruiting anymore as a PIII was being planned. Please correct me if I'm wrong.
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