0001004878-17-000193.txt : 20170815 0001004878-17-000193.hdr.sgml : 20170815 20170814173643 ACCESSION NUMBER: 0001004878-17-000193 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20170814 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170815 DATE AS OF CHANGE: 20170814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEL SCI CORP CENTRAL INDEX KEY: 0000725363 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 840916344 STATE OF INCORPORATION: CO FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11889 FILM NUMBER: 171031830 BUSINESS ADDRESS: STREET 1: 8229 BOONE BLVD . STREET 2: SUITE 802 CITY: VIENNA STATE: VA ZIP: 22182 BUSINESS PHONE: 7035069460 MAIL ADDRESS: STREET 1: 8229 BOONE BLVD. STREET 2: SUITE 802 CITY: VIENNA STATE: VA ZIP: 22182 FORMER COMPANY: FORMER CONFORMED NAME: INTERLEUKIN 2 INC DATE OF NAME CHANGE: 19880317 8-K 1 form8kitem801holdrel8-17.txt FORM 8-K ITEM 8.01 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (date of earliest event reported): August 14, 2017 CEL-SCI CORPORATION ----------------------------- (Exact name of Registrant as specified in its charter) Colorado 01-11889 84-0916344 --------------------------- ------------------ ---------------- (State or other jurisdiction (Commission File No.) (IRS Employer of incorporation) Identification No.) 8229 Boone Boulevard, Suite 802 Vienna, Virginia 22182 ------------------------------------- (Address of principal executive offices, including Zip Code) Registrant's telephone number, including area code: (703) 506-9460 N/A ------------------------------------- (Former name or former address if changed since last report) Check appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below) [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-14(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 8.01 Other Events On August 14, 2017 the Company announced it has received a letter from the U.S. Food and Drug Administration stating that the clinical hold that had been imposed on the Company's Phase 3 cancer study with Multikine has been removed and that all clinical trial activities under this Investigational New Drug application (IND) may resume. On August 14, 2017 the Company issued a press release, filed as Exhibit 99, announcing the release of the clinical hold. Item 9.01 Financial Statements and Exhibits Exhibit Description 99 Press Release dated August 14, 2017 2 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: August 14, 2017 CEL-SCI CORPORATION By: /s/ Patricia B. Prichep -------------------------------------- Patricia B. Prichep Senior Vice President of Operations EX-99 2 form8kitem801ex99aug-17.txt EXHIBIT 99 PRESS RELEASE EXHIBIT 99 8229 Boone Boulevard, Suite 802 COMPANY CONTACT: Vienna, VA 22182. USA Gavin de Windt Telephone (703) 506-9460 CEL-SCI Corporation www.cel-sci.com (703) 506-9460 U.S. FDA REMOVES CLINICAL HOLD ON CEL-SCI'S PHASE 3 HEAD & NECK CANCER TRIAL The Study's 928 patients are being monitored and continue to be followed for protocol-specific outcomes Vienna, VA, August 14, 2017 -- CEL-SCI Corporation (NYSE American: CVM) today announced it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the clinical hold that had been imposed on the Company's Phase 3 cancer study with Multikine* (Leukocyte Interleukin, Inj.) has been removed and that all clinical trial activities under this Investigational New Drug application (IND) may resume. Multikine is being studied as a potential first-line (before any other cancer treatment is given) immunotherapy that is aimed at harnessing the patient's own immune system to produce an anti-tumor response. Nine hundred twenty-eight (928) newly diagnosed head and neck cancer patients have been enrolled in this Phase 3 cancer study and all the patients who have completed treatment continue to be followed for protocol-specific outcomes in accordance with the Study Protocol. The study's primary endpoint is a 10% increase in overall survival for patients treated with the Multikine treatment regimen plus standard of care (SOC) versus those who receive SOC only. The determination if the study's primary end point has been met will occur when there are a total of 298 deaths in those two groups. Current SOC for this indication is surgery, followed by radiation therapy alone or followed by concurrent radio-chemotherapy. There is a clear and unmet medical need for a new treatment in this indication as the last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago. The FDA has also designated Multikine an Orphan Drug for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck (SCCHN). About Head and Neck Cancer Head and neck cancer describes squamous cell carcinomas located inside the neck, mouth, nose, and throat. According to the World Health Organization, the annual incidence of head and neck cancer is approximately 550,000 cases worldwide, with about 300,000 deaths each year. Risk factors involved with head and neck cancer include heavy alcohol use, tobacco use, and the cancer causing type of human papilloma virus (HPV). 2 About CEL-SCI Corporation CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K and 10-K/A for the year ended September 30, 2016. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI 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 for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. 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.