<SEC-DOCUMENT>0001004878-17-000054.txt : 20170307
<SEC-HEADER>0001004878-17-000054.hdr.sgml : 20170307
<ACCEPTANCE-DATETIME>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
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>form8kfdaresp3-17.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): 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
<PAGE>


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
<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: March 6, 2017

                                       CEL-SCI CORPORATION


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




                                       3

<PAGE>


</TEXT>
</DOCUMENT>
<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>form8kitem801ex99march-17.txt
<DESCRIPTION>EXHIBIT 99
<TEXT>

                                   EXHIBIT 99

<PAGE>


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

<PAGE>


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