CEL-SCI Corporation Issues Letter to Shareholders - Seite 3

To help us evaluate these factors we engaged an independent statistical group and asked them to determine if the survival of patients with squamous cell carcinoma (cancer) of the oral cavity and soft palate (the same patient population as we enrolled in our Phase 3 study) treated in the U.S. presumably with the same SOC and in the same manner as the patients in our Phase 3 study, had changed during the time patients were enrolled and treated in our Phase 3 study. The statistical group analyzed the most recently available data from the U.S. Government National Cancer Registry called SEER. The Cancer Registry contains data about, among other things, cancer patients’ disease diagnosis, staging at diagnosis, treatments administered, and survival of specific cancer populations in the U.S. The survival data in the U.S. available from the SEER Cancer Registry for the types of patients treated in our Phase 3 study during the same time our study was conducted indicated that these patients had only a 47% survival at three (3) years and a 37% survival at five (5) years, establishing that the survival in treating those patients who had been receiving the best SOC treatments available in the U.S. did not improve during our long Phase 3 study. That means that the SOC treatment and any follow-up treatments once the cancer recurred do not look to be responsible for the patients apparently living longer in our Phase 3 study.

After treatment with Multikine and the SOC, the patients enrolled in our study can take any medicine if their tumor recurs. We therefore considered the possibility that the introduction in late 2016 of Keytruda and Opdivo, two new cancer immunotherapy drugs for recurrent head and neck cancer, might be responsible for the lower than expected death rate in our study. We do not think that this is the case based on the following: 1) The use of Keytruda and Opdivo as a treatment should already be accounted for in the SEER database results which were evaluated since these drugs were used in the U.S. for patients with recurring disease. 2) Our study was enrolled in 20+ countries and these drugs were not available in many of those countries during the time patients were enrolled and treated in our study. In most of those countries Keytruda and Opdivo are still not available, even today. 3) Keytruda and Opdivo show a survival benefit of about 3 months in head and neck cancer once the initial treatment has failed and the tumor recurs. Any patient who received a 3-month survival benefit from Keytruda or Opdivo would already have passed on since the patients in the Phase 3 study entered/completed treatment between 3.5 and 9 years ago. Therefore, the delay in reaching 298 events in the Multikine Phase 3 study should not be due to Keytruda and Opdivo.