Cel Sci Corporation (CVM)

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CEL-SCI Announces Update on Phase 3 Cancer Trial Results

Data lock is complete, final statistical analysis being conducted

December 07 2020

CEL-SCI Corporation (NYSE American: CVM) announced today that the Phase 3 study is in the final stage of review which involves statistical analysis of all study data. Data lock has already been completed.

Since the required number of events to allow statistical analysis of CEL-SCI’s Phase 3 study in head and neck cancer was reached earlier this year, the Clinical Research Organizations (CROs) managing CEL-SCI’s Phase 3 study, Ergomed and ICON, had been performing data base lock of the study results. Data base lock is a very important and time intensive process that needs to be completed to ensure any study’s data are accurate and as complete as possible before the results of the study can be statistically evaluated and reliable conclusions drawn regarding the study’s outcome(s). This process was particularly complicated for CEL-SCI’s Phase 3 study because the study was conducted in over 20 countries on three continents, and many of these countries had, and still have, severe shutdowns due to the COVID-19 pandemic.

The statistical analysis of our Phase 3 study data is being performed according to a statistical analysis plan that was approved in advance of data lock. The analysis is being conducted by independent unbiased contractors. CEL-SCI is not involved in this process. Once the analysis has been completed, CEL-SCI will become privy to the study results. At that time, shareholders will be advised of the results through a public announcement. CEL-SCI also plans to publish the results in peer reviewed scientific journals.

“Our goal has been to create a cancer drug that is both non-toxic and works with the body’s immune system to increase the ‘intent to cure’ success rate of the first-line cancer treatment. We believe that immunotherapy should be administered before, not after, surgery, radiation and chemotherapy have damaged the immune system. We further believe that success in head and neck cancer should lead to many new ways of helping cancer patients.” said Geert Kersten, CEO of CEL-SCI Corporation. “We are grateful to our shareholders for believing in us and supporting us during the very long Phase 3 study.”