The following letter was provided to shareholders by CEL-SCI Corporation (NYSE MKT: CVM) for today’s annual shareholder meeting:
Dear Fellow Shareholders:
Last year, 2011, was an exciting year for us because we were finally able to start our Phase III clinical trial for our investigational cancer drug Multikine® (Leukocyte Interleukin, Injection)*. This trial is the largest head and neck cancer study ever conducted in the world and is designed to hopefully give us approval to market Multikine throughout the world.
This trial, which is designed to prove to the most rigorous standards that Multikine works, was launched in dozens of hospitals located in eight countries on three continents. All of us at CEL-SCI are very proud of this major accomplishment. If we are successful in proving that the addition of Multikine to the current cancer therapies increases the patients’ overall survival, we would then expect to submit the Multikine drug dossier to regulatory agencies around the world for approval.
It has been a long road to this point, but that appears to be the norm for a “first in a new class” drug such as Multikine. Our vision for Multikine has always been that, by activating the immune response against the cancer, it could be a useful addition to the current treatment options used by cancer patients and doctors – and that it should add little to no toxicity to the existing treatments being used. With this vision in mind we selected head and neck cancer, a hard to treat and devastating disease, as a first target for Multikine. Head and neck cancer represents a clear unmet medical need, and there is currently one standard of care for its treatment worldwide. By adding Multikine to the current standard of care we hope to improve the overall survival currently achievable in these patients. As only little progress has been achieved in these patients in the past 50 years, this would be seen as a major achievement.