Full PR:
CEL-SCI Corporation (NYSE American: CVM) announced today that it has been notified that it has reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The database is now being prepared for database lock. Once the database has been locked the final analysis of the trial results can be performed. CEL-SCI will continue to remain blinded to the study results throughout this process. CEL-SCI will be advised of the results when the analysis is completed and the study results will be announced to the public and investors at that time.
The CROs involved in study management are generating the remaining queries, performing source data verification, completing medical review, and building the final database needed to produce the final tables, listings, and figures.
Geert Kersten, Chief Executive of CEL-SCI said, “We have conducted this 928 patient pivotal Phase 3 study for over nine years because we hope to improve the current standard of care for advanced primary head and neck cancer. We believe that the activation of the immune system by Multikine BEFORE the ravages of surgery, radiation and chemotherapy can improve the survival of these patients. I am incredibly proud of the dedication of our amazing team who has made all of this possible.”
