<SEC-DOCUMENT>0001004878-16-000503.txt : 20160928
<SEC-HEADER>0001004878-16-000503.hdr.sgml : 20160928
<ACCEPTANCE-DATETIME>20160928172114
ACCESSION NUMBER:		0001004878-16-000503
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20160926
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20160928
DATE AS OF CHANGE:		20160928

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:		161907764

	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>form8k801studyhold9-16.txt
<DESCRIPTION>8-K RE STUDY HOLD PR
<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): September 26, 2016

                             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
<PAGE>


Item 8.01   Other Events

      On September 26, 2016, the Company issued a press release, filed as
Exhibit 99, concerning a clinical hold on its head and neck cancer study.

Item 9.01  Exhibits

Exhibit
Number     Description of Document
------     -----------------------

  99       September 26, 2016 press release.







                                       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:  September 28, 2016

                                      CEL-SCI CORPORATION


                                       By: /s/ Patricia B. Prichep
                                           -----------------------------------
                                          Patricia B. Prichep
                                          Senior Vice President of Operations







                                       3

</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>form8k801exh999-16.txt
<DESCRIPTION>EXH 00 - PR RE STUDY HOLD
<TEXT>


                                   EXHIBIT 99

<PAGE>


CEL-SCI CORPORATION
                                                         Contact: Gavin de Windt
                                                      Investor Relations Manager
                                                             Phone: 703 506-9460
                                              Email address:gdewindt@cel-sci.com

           CEL-SCI REPORTS CLINICAL HOLD ON HEAD AND NECK CANCER STUDY

VIENNA,  VA, September 26, 2016 - CEL-SCI  Corporation (NYSE MKT: CVM) announced
today  that  it  has  received  verbal  notice  from  the  U.S.  Food  and  Drug
Administration (FDA) that its Multikine (Leukocyte  Interleukin Injection) Phase
3 clinical  trial in  advanced  primary  head and neck cancer has been placed on
clinical  hold.  Pursuant to this  communication  from FDA,  patients  currently
receiving  study  treatments  can  continue to receive  treatment,  and patients
already  enrolled in the study will  continue to be  followed.  CEL-SCI was also
told to  expect  a  formal  letter  from the FDA  within  30 days and will  work
diligently  with the FDA to obtain the release of the clinical  hold.  The study
currently has about 926 patients enrolled.

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. 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  has been completed at
the University of Maryland.  The latter  indication is now in a Phase 1 trial at
UCSF.  CEL-SCI has issued 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.  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

<PAGE>

factors set forth from time to time in CEL-SCI  Corporation's  filings  with the
Securities and Exchange  Commission,  including but not limited to its report on
Form 10-K for the year ended  September  30,  2015.  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 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  have 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 (Leukocyte Interleukin,  Injection). 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 currently in progress.





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