<SEC-DOCUMENT>0001004878-17-000193.txt : 20170815
<SEC-HEADER>0001004878-17-000193.hdr.sgml : 20170815
<ACCEPTANCE-DATETIME>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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>form8kitem801holdrel8-17.txt
<DESCRIPTION>FORM 8-K ITEM 8.01
<TEXT>

                                  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))

<PAGE>

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
<PAGE>

                                   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
</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>form8kitem801ex99aug-17.txt
<DESCRIPTION>EXHIBIT 99 PRESS RELEASE
<TEXT>




                                   EXHIBIT 99




<PAGE>


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
<PAGE>

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.
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
