Ayala Pharmaceuticals Inc (ADXS)

[ubmmg]

Easy,

GOG P2 results were best ever. Don't disagree with that statement. The things would have been different if we just started P3 in the same settings as P2 (more patients and the same control points). However, we got SPA and our Phase 3 is no longer a direct continuation of P2. Current Phase 3 tests LM in adjuvant settings. See the CT:
[url][/url][tag]https://clinicaltrials.gov/ct2/show/NCT02853604?term=advaxis&draw=1&rank=4[/tag]
We likely are not going to get any update for 3 years or so. The silence is short's best friend. Phase 3 is virtually a new trial.

Primary Outcome Measures:
Disease free survival (DFS) [ Time Frame: 5 Years ]
To compare the disease free survival (DFS) of ADXS11-001 to placebo administered in the adjuvant setting following concurrent chemotherapy and radiotherapy (CCRT) administered with curative intent to subjects with high-risk locally advanced squamous, adenosquamous, or adenocarcinoma of the cervix (HRLACC).


Secondary Outcome Measures:
Safety & tolerability Overall survival (OS) [ Time Frame: 5 Years ]
To determine and compare the frequency and severity of adverse events (AEs) as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for the regimens administered on this study.


Estimated Enrollment: 450
Study Start Date: September 2016
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)