CEL-SCI says length of Phase 3 study could be sign of Multikine’s efficacy

CEL-SCI Corporation issued a letter to its shareholders, which read in part, “The first 4 months of this year have already been very positive for us. Our Phase 3 head and neck cancer study is continuing and we are moving forward with our Rheumatoid Arthritis product development. Since January 1, we have received about $9.6 million from the conversion of warrants to finance our ongoing projects. We believe the following developments with regard to the Multikine* Phase 3 trial have contributed to additional investments in our Company: We have not yet hit the primary endpoint of our 928 patient Phase 3 study with our investigational cancer immunotherapy drug Multikine. That endpoint will be reached when 298 events (deaths) have occurred and are recorded in the two main comparator arms of the study. Since the scientific literature does not suggest an improvement in the survival rates for oral head and neck cancer patients receiving standard of care only, we believe a delay in reaching these 298 events could be a good sign for the potential effectiveness of Multikine…At the end of March 2019, we had an official review of the Phase 3 study by the IDMC. The IDMC recommended to “continue the trial until the appropriate number of events has occurred”. The IDMC reviews all the study results at the time of each IDMC meeting. Had the study results indicated that meeting the primary survival endpoint of the study would no longer be possible, the study could have been deemed futile. The IDMC recommended to continue the study. In our Phase 3 trial the primary endpoint is met by reaching a 10% improvement in the overall survival of the group of patients receiving the Multikine treatment regimen plus the Standard of Care versus the overall survival of the group of patients receiving the Standard of Care only. Futility has been on the minds of investors a lot more recently, because finding futility in the case of a Phase 3 Alzheimer study by Biogen in March 2019 resulted in a loss to shareholders of close to $30 billion…We are benefiting from renewed interest in CEL-SCI’s Multikine cancer immunotherapy by meeting with new investors weekly. What is striking is that hardly any of them have ever heard of CEL-SCI, even though we have been running the largest study ever in head and neck cancer. We think that the absence of new clinical data for over 8 years (we are blinded to the Phase 3 results and therefore could not announce clinical data) is probably the reason for CEL-SCI being virtually unknown. But, while that presented a problem in the past, it now represents a fantastic opportunity. New investors are very interested for two reasons: 1) during our Phase 3 study cancer immunotherapy has become accepted as a new treatment modality for cancer; and 2) investors prefer investing near the end of this long trial. It has taken decades to get to this point in time, but we are finally near the end, and we feel good about it. Each of the last few years I have purchased more CEL-SCI stock. And I did so again this week when I purchased $100,000 worth of restricted CEL-SCI stock at $6.86 directly from the Company at the full market price. Several others from our senior management team and one member of the Board of Directors have joined me and purchased another $110,000 worth of CEL-SCI stock on the same terms. ”

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