The following letter is being released by CEL-SCI Corporation (NYSE AMEX: CVM) to its shareholders:
Dear Fellow Shareholders:
With the start of the New Year, I thought it would be helpful to provide you with a review of the progress made in our Multikine cancer Phase III clinical trial during the last year and our thoughts for the future of Multikine.
During 2011, we made great operational progress in bringing our investigational cancer drug Multikine® (Leukocyte Interleukin, Injection)* closer to market. Our Phase III clinical trial for head and neck cancer, 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. This trial is the largest head and neck cancer trial in the world. 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 little to no progress has been achieved in these patients in almost 50 years, this would be seen as a major achievement.