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.