CEL-SCI Corporation Issues Letter to Shareholders - Seite 2

We started accruing patients to our Phase 3 study in early 2011 and completed enrollment of 928 cancer patients in September 2016. Per the study protocol, 298 deaths (events) will have to occur in the two comparator groups (Multikine treatment regimen plus SOC vs. SOC alone) in order to determine whether the study’s primary endpoint, a 10% increase in overall survival in favor of the Multikine regimen treatment group, has been achieved.

Based on the known survival statistics available for the patient population in our study when we initiated our Phase 3 trial, we had expected to have reached the required 298 events some time ago. Clearly, it is a good thing when these very sick stage 3 and 4 cancer patients live longer and/or do not die. In fact, that is the goal of the study. Since we are blinded to the details of the study results, we cannot know definitively whether it is our investigational immunotherapy Multikine treatment regimen or something else that is responsible for patients living longer. Nevertheless, it would not come as a surprise for us to see a survival benefit from our Multikine treatment regimen in the Phase 3 trial because we saw an approximate 33% survival benefit in our final Phase 2 study. In that final Phase 2 study, the Multikine treatment regimen was administered to patients just as it is in the Phase 3 study. Also, the final Phase 2 study showed, by pathology, that in just three weeks of administering our Multikine treatment regimen, 100% of the tumor was eliminated in some patients and approximately 50% of the tumor was eliminated in many of the other patients. Twenty-four regulators, including the U.S. FDA, gave us permission to run our pivotal Phase 3 clinical trial based on these clinical results and other data.

We have discussed at great length, internally and with outside experts, what factors, other than the Multikine treatment regimen, might be contributing to what appears to be a better than expected survival in this Phase 3 study. The most obvious factors to consider are 1) the treatments that patients are receiving, either as the first line treatment (SOC) for newly diagnosed cancer or as treatment of a tumor that has recurred, have improved during our Phase 3 trial or 2) the apparent increased survival of the patients in our study is related to the dropout rate of patients since that would reduce the sample size from which events can be collected.