CEL-SCI Corporation Issues Letter to Shareholders
CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders. This letter will be sent to the Company’s shareholders along with the proxy to the upcoming annual meeting.
Dear Fellow Shareholders:
A long time ago we set out to create a cancer drug that addresses the following concerns:
- has little to no toxicity,
- extends life, or better yet, aims to cure cancer patients and
- is not prohibitively expensive.
Even in those days, when the so-called experts ridiculed our efforts and goals saying ‘it could not be done’, we believed that the immune system held the key to our health and ability to effectively fight cancer. The challenge we faced was how to develop a medicine that can harness the immune system’s power to fight cancer. Now the application of immunotherapy in the treatment of cancer has gone from “it can/will not work” to “this is the future.” Today’s cancer immunotherapies are generally being developed for patients who have already had surgery, radiation and/or chemotherapy or for patients for whom surgery is not an option. These patients usually also have compromised immune systems. The Phase 3 trial of our investigational cancer immunotherapy, Multikine* (Leukocyte Interleukin Injection) is designed to demonstrate that we can be even more successful in increasing the overall survival (OS) of cancer patients when we stimulate their immune systems before they are ravaged by the effects of surgery, radiation, and/or chemotherapy.
The global pivotal Phase 3 clinical trial, which we started nine years ago for our Multikine immunotherapy in advanced primary head and neck cancer patients, tests the hypothesis that giving the Multikine treatment regimen right after cancer diagnosis, BEFORE surgery, radiation or radiochemotherapy, will increase the OS of patients beyond the OS achieved with the current “intent to cure” standard of care (SOC) therapies. In short, we seek to make the current “intent to cure” SOC treatment more successful. And we hope to do so with little to no toxicity added by our Multikine immunotherapy. Our first goal is to prove this concept in the treatment of newly diagnosed patients with advanced primary head and neck cancer, about 4% of all cancers. This is an indication in dire need of a new and effective treatment because the last drug approved by the U.S. FDA for this indication was about 60 years ago, and just about everyone agrees that the current treatments are horrible and fail to properly address this unmet medical need. We hope to extend this concept to other solid tumors as well should our Phase 3 trial be successful.