0001004878-17-000054.txt : 20170307 0001004878-17-000054.hdr.sgml : 20170307 20170306181454 ACCESSION NUMBER: 0001004878-17-000054 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20170301 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170307 DATE AS OF CHANGE: 20170306 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: 17669130 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 form8kfdaresp3-17.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): March 1, 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)) 1 Item 8.01 Other Events CEL-SCI announced that it has received the official minutes from its February 8, 2017 meeting with the U.S. Food and Drug Administration (FDA) in regards to the partial clinical hold placed on CEL-SCI's Phase 3 head and neck cancer study. Pursuant to the partial clinical hold, patients currently receiving study treatments can continue to receive treatment at the discretion of their physicians and with their consent, and patients already enrolled in the study will continue to be followed. As of March 6, 2017, 928 patients were enrolled in this study. The purpose of the February 8, 2017 meeting with the FDA was to discuss the issues raised by the FDA with respect to the partial clinical hold and to obtain the FDA's input and clarification on how to address these issues. The Action Items for CEL-SCI to pursue per the minutes from the FDA are the following: 1) Provide an updated Investigator's Brochure and current procedures for compliance with requirements under 21 CFR 312 Subpart D to address the partial clinical hold. 2) Provide a list of major protocol deviations, which CEL-SCI believes will affect study results, and provide a plan to identify major protocol deviations across all patients enrolled in the Phase 3 protocol. CEL-SCI is working diligently on responding to all Action Items. It is CEL_SCI's belief that addressing the Action Items listed above will support a favorable decision by the FDA to lift the partial clinical hold. While CEL-SCI believes that it understands the Action Items, it is possible that CEL-SCI has not understood all issues involved. All of CEL-SCI's work is subject to the FDA's review of CEL-SCI's submission upon its completion and may or may not result in the lifting of the partial clinical hold. Item 9.01 Financial Statements and Exhibits On March 6, 2017 CEL-SCI issued a press release, attached as Exhibit 99, concerning the receipt of the FDA's minutes of the February 8, 2017 meeting. 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: March 6, 2017 CEL-SCI CORPORATION By: /s/ Patricia B. Prichep ----------------------------- Patricia B. Prichep Senior Vice President of Operations 3 EX-99 2 form8kitem801ex99march-17.txt EXHIBIT 99 EXHIBIT 99 CEL-SCI CORPORATION 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 CEL-SCI GIVES UPDATE ON PARTIAL CLINICAL HOLD ON PHASE 3 HEAD AND NECK CANCER STUDY WITH MULTIKINE Vienna, VA, March 6, 2017 - CEL-SCI Corporation (NYSE MKT: CVM) announces that it has received the official minutes from its February 8, 2017 meeting with the U.S. Food and Drug Administration (FDA) in regards to the partial clinical hold placed on the Phase 3 head and neck cancer study with CEL-SCI's investigational drug Multikine* (Leukocyte Interleukin, Injection) on September 26, 2016. Pursuant to this partial clinical hold, patients currently receiving study treatments can continue to receive treatment at the discretion of their physicians and with their consent, and patients already enrolled in the study will continue to be followed. 928 patients are enrolled in this study. The purpose of the Type A (face-to-face) meeting with the FDA was to allow an open and frank discussion of the clinical hold issues raised by the FDA and to secure the FDA's input and clarification on how to address the partial hold issues. The Action Items for CEL-SCI to pursue per the minutes from the FDA are the following: 1) Provide an updated Investigator's Brochure and current procedures for compliance with requirements under 21 CFR 312 Subpart D to address the partial clinical hold. 2) Provide a list of major protocol deviations, which CEL-SCI believes will affect study results, and provide a plan to identify major protocol deviations across all patients enrolled in the Phase 3 protocol. CEL-SCI is working diligently on responding to all action items. CEL-SCI is giving the FDA issues top priority. It is our belief that addressing the Action Items listed above will support a favorable decision by the FDA to lift the partial clinical hold. While we think that we have understood the Action Items, it is possible that we have not understood all issues involved. All of our work is subject to the FDA's review of our submission upon its completion and may or may not result in the lifting of the partial clinical hold. 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. Its lead investigational immunotherapy, Multikine (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of cervical dysplasia in HIV/HPV co-infected women, and the treatment of peri-anal warts in HIV/HPV co-infected men and women. A Phase 1 trial of the former indication (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan. CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis. 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. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. 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 and that is currently subject to a clinical hold on enrollment of additional new patients.