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1. ORGANIZATION | 12 Months Ended
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Sep. 30, 2017
Notes to Financial Statements |
1. ORGANIZATION | CEL-SCI Corporation (the Company) was incorporated on March 22, 1983, in the state of Colorado, to finance research and development in biomedical science and ultimately to engage in marketing and selling products. The Company is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational therapy, Multikine® (Leukocyte Interleukin, Injection), is currently in a pivotal Phase 3 clinical trial involving head and neck cancer, for which the Company has received Orphan Drug Status from the United States Food and Drug Administration (FDA). If the primary endpoint of this global study is achieved, the results will be used to support applications to regulatory agencies around the world for worldwide commercial marketing approvals as a first line cancer therapy. The Company’s immune therapy, Multikine, is being used in a different way than immune therapy is usually used. It is given before any other therapy has been administered because that is when the immune system is thought to be strongest. It is also administered locally to treat tumors or infections. For example, in the Phase 3 clinical trial, Multikine is given locally at the site of the tumor as a first line treatment before surgery, radiation and/or chemotherapy. The goal is to help the intact immune system kill the micro metastases that usually cause recurrence of the cancer. In short, CEL-SCI believes that local administration and administration before weakening of the immune system by chemotherapy and radiation will result in higher efficacy with less or no toxicity. Multikine (Leukocyte Interleukin, Injection) is the full name of this investigational therapy, which, for simplicity, is referred to in the remainder of this document as Multikine. Multikine is the trademark that the Company has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved by the FDA or any other regulatory agency. Neither has its safety or efficacy been established for any use. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress. Multikine has been cleared by the regulators in twenty four countries around the world, including the U.S. FDA, for a global Phase 3 clinical trial in advanced primary (not yet treated) head and neck cancer patients. On September 26, 2016, the Company received verbal notice from the FDA that the Phase 3 clinical trial has been placed on clinical hold. On August 10, 2017, the Company received a letter from the FDA stating that the clinical hold that had been imposed on the Phase 3 cancer study with Multikine has been removed and that all clinical trial activities for the Phase 3 study may resume. On December 7, 2017, the Company announced that the Independent Data Monitoring Committee (IDMC) has completed its review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the IDMC by the Clinical Research Organization (CRO) responsible for data management of this Phase 3 study. The IDMC made the following observation and recommendation: a) the IDMC saw no evidence of any significant safety questions and b) the IDMC recommends continuing the study. On December 11, 2017, the Company announced that the Phase 3 study was fully enrolled. The activities in the Phase 3 study are now focused on the follow-up of the patients enrolled to determine if there is a survival benefit in favor of Multikine.

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