<SEC-DOCUMENT>0001654954-17-005359.txt : 20170606
<SEC-HEADER>0001654954-17-005359.hdr.sgml : 20170606
<ACCEPTANCE-DATETIME>20170605181030
ACCESSION NUMBER:		0001654954-17-005359
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20170605
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20170606
DATE AS OF CHANGE:		20170605

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:		17892495

	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>cvm_8k.htm
<DESCRIPTION>CURRENT REPORT
<TEXT>
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UNITED STATES</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">SECURITIES
AND EXCHANGE COMMISSION</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">WASHINGTON,
D.C. 20549</font></div>
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FORM 8-K</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">CURRENT
REPORT</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Pursuant
to Section 13 or 15(d) of the</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Securities
Exchange Act of 1934</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date of
Report (date of earliest event reported): June 5, 2017</font></div>
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</font></font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px"><font style="text-decoration: underline">
CEL-SCI CORPORATION</font><br></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Exact
name of Registrant as specified in its charter)</font></div>
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<font style="text-decoration: underline"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Colorado</font></font></div>
</td>
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<font style="text-decoration: underline"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">001-11889</font></font></div>
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<font style="text-decoration: underline"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">84-0916344</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(State
or other jurisdiction</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(Commission File
No.)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">of
incorporation)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Identification
No.)</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">8229
Boone Boulevard, Suite 802</font></div>
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<font style="font-family: Times New Roman; font-size: 13px;"><font style="font-family: Times New Roman; font-size: 13px">
<font style="text-decoration: underline">Vienna, Virginia
22182&#xA0;</font></font><br></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;(Address
of principal executive offices, including Zip Code)</font></div>
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<div style="text-align: center; margin-left: 0px; text-indent: 0px; margin-right: 0px;"><font style="font-family: Times New Roman; font-size: 13px">Registrant&#x2019;s
telephone number, including area code: <font style="text-decoration: underline">(703) 506-9460</font></font></div>
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</font></div>
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<font style="font-family: Times New Roman; font-size: 13px;">&#xA0;</font><font style="font-family: Times New Roman; font-size: 13px"><font style="text-decoration: underline">N/A</font></font></div>
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name or former address if changed since last report)</font></div>
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<font>&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; text-indent: 0px; margin-right: 0px;"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Item
8.01&#xA0;&#xA0;&#xA0; Other Events</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 48px">
<font style="font-family: Times New Roman; font-size: 13px">On June
5, 2017 the Company issued a press release, filed as Exhibit 99,
announcing that it has responded to the U.S. Food and Drug
Administration&#x2019;s (FDA) most recent
communication.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; text-indent: 0px; margin-right: 0px;"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Item&#xA0;9.01&#xA0;&#xA0;&#xA0;
Exhibits</font></div>
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<font style="text-decoration: underline"><font style="font-family: Times New Roman; font-size: 13px">Number</font></font></div>
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<font style="text-decoration: underline"><font style="font-family: Times New Roman; font-size: 13px">Description of
Document</font></font></div>
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<td style="vertical-align: top; width: 12%;">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><a href="cvm_ex99.htm"><font style="font-family: Times New Roman; font-size: 13px">99</font></a></div>
</td>
<td style="vertical-align: top; width: 88%;">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px;">
<font style="font-family: Times New Roman; font-size: 13px">June 5,
2017 Press Release.</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
June 5, 2017</font></div>
</td>
<td colspan="2" rowspan="1" style="vertical-align: bottom; width: 38%;"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">CEL-SCI
CORPORATION</font></td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">By:&#xA0;&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 35%; border-bottom: 2px solid black; white-space: nowrap;">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-size: 13px; font-family: Times New Roman">/s/&#xA0;</font>
<font style="font-family: Times New Roman; font-size: 13px">Patricia B.
Prichep</font></div>
</td>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px"><font style="font-family: Times New Roman; font-size: 13px">Patricia B.
Prichep</font></div>
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<td style="width: 35%; vertical-align: top;"><font style="font-family: Times New Roman; font-size: 13px">Senior Vice
President of Operations</font></td>
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<DOCUMENT>
<TYPE>EX-99
<SEQUENCE>2
<FILENAME>cvm_ex99.htm
<DESCRIPTION>PRESS RELEASE
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Exhibit 99</font></div>
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<font style="color: #7F7F7F">N</font><font style="font-variant: small-caps; color: #7F7F7F">EWS
RELEASE</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">8229
Boone Boulevard, Suite 802</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">COMPANY
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<font style="font-family: Times New Roman; font-size: 13px">Vienna,
VA 22182. USA</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Gavin
de Windt</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">CEL-SCI
Corporation</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">(703)
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CEL-SCI SUBMITS FDA RESPONSE FOR ITS PHASE 3 HEAD AND</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 16px">
NECK CANCER TRIAL</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
928 patients have been enrolled, treated, and are now being
followed for Study&#x2019;s Primary Endpoint</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold">
Vienna, VA, June 5, 2017</font> -- CEL-SCI Corporation <font style="font-weight: bold">(NYSE MKT: CVM)</font> today announced that it
has responded to the U.S. Food and Drug Administration&#x2019;s
(FDA) most recent communication from May 2017 about the clinical
hold imposed on the Company&#x2019;s Phase 3 head and neck cancer
study with Multikine* (Leukocyte Interleukin, Inj.).</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">The
hold issues addressed in the FDA communication were that the
study&#x2019;s Investigator Brochure (IB) and the &#x201C;Dear
Investigator&#x201D; letter need to be revised. Specific
deficiencies and their locations in each of the documents were
identified, and directions were given as to the specific
information that should be included in the revisions of these
documents. CEL-SCI revised the documents exactly as directed by the
FDA. If the FDA finds the revisions made to the two documents to be
satisfactory, CEL-SCI is hopeful that all of the clinical hold
issues have now been addressed, and the FDA will consider lifting
the clinical hold.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">As of
September 2016, nine hundred twenty-eight (928) head and neck
cancer patients have been enrolled and have completed treatment in
the Phase 3 study. In accordance with the study protocol, the
FDA&#x2019;s instructions, and subject to the clinical hold, CEL-SCI
continues to follow these patients.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">The
study endpoint is a 10% increase in overall survival of patients
between the two main comparator groups in favor of the group
receiving the Multikine treatment regimen. The determination if the
study end point is met will occur when there are a total of 298
deaths in those two groups.</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
About CEL-SCI Corporation</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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Forward-Looking Statements</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-style: italic; font-family: Times New Roman; font-size: 13px">
* 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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Cel-Sci
Press Release FDA Response 6-5-17</font></div>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
