The following letter is being released by CEL-SCI Corporation (NYSE MKT: CVM) to its shareholders:
Dear Fellow Shareholders:
As you know, we are currently running the largest ever Phase III clinical trial in head and neck cancer, a disease with a clear unmet medical need, with our investigational Multikine
immunotherapy. The trial is currently being conducted in eight countries on three continents. It is designed so that if successfully completed the results will allow us to seek marketing approval in the key markets around the world. Our clinical study is the first trial in which immunotherapy is given before the standard of care (SOC) cancer therapies which consists of surgery, radiation and chemotherapy. Multikine is given prior to SOC because we believe that the stimulation of the immune system of a cancer patient after those cancer treatments is extremely difficult due to the known immuno-suppressive effects of surgery, radiation and chemotherapy. We are confident that our approach of early stimulation of the immune response will be proven to be correct.
This fall we took a big first step towards clearing a key hurdle in the Phase III trial. We were able to announce that our study’s Independent Data Monitoring Committee (IDMC), when reviewing the study data collected to date, advised that the study should be continued since the committee saw no safety signals which should end the study. We view this as a very positive event because safety and tolerability are key risks in all Phase III clinical trials. In October 2012 a Phase III study of a drug owned by Reata Pharmaceuticals and licensed to Abbott Labs for about $450 million was stopped due to safety problems. Several years ago Pfizer had to stop the Phase III study for its Lipitor successor at an estimated cost of $1 billion due to safety problems. In fact, a recent study estimated that up to 30% of Phase III trials fail on safety. So far our Phase III study results for the safety profile of this novel approach and investigational therapy regimen appear to track the results we obtained in our Phase II studies, and that is exactly what we wanted to see.