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CVM

CEL-SCI

$3.02

-0.12 (-3.82%)

08:27
03/25/19
03/25
08:27
03/25/19
08:27

CEL-SCI says 'success rests on the Phase 3 clinical trial' in shareholder letter

aA letter was sent by CEL-SCI Corporation to its shareholders for the upcoming annual meeting, which read in part: The enrollment of 928 patients in our Phase 3 clinical trial of Advanced Primary Head and Neck Cancer was completed in September of 2016. For the study to end we have to wait for 298 events in the two main groups to show a survival benefit. Based on published survival data, we had already expected to have reached the 298 events. Instead, we had to extend the contracts with the Clinical Research Companies running the Phase 3 study because we had not yet reached the required number of events in the study. While we do not like waiting, we also recognize that this may be a positive development for our Phase 3 study since Multikine may be the reason for not yet having reached 298 events. Let us explain to you why. The primary objective of our Phase 3 study is to demonstrate that, by administering the Multikine treatment regimen prior to the current standard of care therapy, surgery followed by radiotherapy or followed by combined radiochemotherapy, we can achieve a 10% increase in overall survival of the Multikine treated head and neck cancer patients. In a much smaller uncontrolled Phase 2 study Multikine appeared to increase overall survival even more. If Multikine does increase overall survival in our well controlled Phase 3 study by 10%, it will likely take longer to reach 298 events. Our ultimate goal is to show that Multikine, when given before surgery, radiation and chemotherapy have weakened the immune system, improves the cancer patients' survival and confers clinical benefit. Should we be successful in reaching this goal, we hope to extend the use of Multikine to treat other cancers and maybe even other diseases...Our Phase 3 study in head and neck cancer has taken eight years. Throughout all of these years, due to the study design of the Phase 3 clinical trial, we had no clinical data to report while the trial was ongoing. That is akin to an eight year drought. However, we are now finally at the end of the study and investors are becoming interested again. Our valuation was a mere $20M when we sent you a shareholder letter in July 2018. Now, in March 2019, it is approximately $90M. We had many millions of dollars in warrant exercises providing the company over $12M of cash in the past 10 months. We have a clean balance sheet with no debt. Several large and well known funds have returned to our stock. New investors in the US, Canada, and Europe are taking positions. We are on the right path. Of course, our success rests on the Phase 3 clinical trial data...In summary, we want to give you the details of when patients were enrolled and the survival assumptions for the SOC group in our Phase 3 study: Approximately 135 patients were enrolled in the study from 2011 to 2013, about 195 were enrolled in 2014, about 340 in 2015, and about 260 in 2016. The last patient was enrolled in the study in September 2016. The study protocol assumes an overall survival rate of about 55% at 3 years for the SOC treatment group alone, but obviously the event rate in patients who have been in the study longer than 3 years will be higher."

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