0001004878-13-000325.txt : 20131101
0001004878-13-000325.hdr.sgml : 20131101
20131101101812
ACCESSION NUMBER: 0001004878-13-000325
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 2
CONFORMED PERIOD OF REPORT: 20131031
ITEM INFORMATION: Other Events
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20131101
DATE AS OF CHANGE: 20131101
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: 131184647
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
form8karbitnov-13.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): October 31, 2013
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 October 31, 2013, the Company issued a press release, filed as Exhibit
99, announcing commencement of arbitration proceedings against inVentive
Clinical, LLC, the Company's former clinical research organization.
Item 9.01. Financial Statements and Exhibits
Number Description
99 Press Release
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: November 1, 2013 CEL-SCI CORPORATION
By: /s/ Patricia B. Prichep
--------------------------------
Patricia B. Prichep, Senior Vice
President of Operations
3
EX-99
2
form8karbexh99nov-13.txt
EXHIBIT 99 PRESS RELEASE
EXHIBIT 99
CEL-SCI CORPORATION NEWS RELEASE
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 ANNOUNCES INITIATION OF ARBITRATION
AGAINST FORMER CLINICAL RESEARCH ORGANIZATION
Vienna, VA, October 31, 2013 - CEL-SCI Corporation (NYSE MKT: CVM) announced
today that it has initiated an arbitration claim against inVentiv Clinical, LLC
(f/k/a PharmaNet, LLC and PharmaNet GmbH (f/k/a PharmaNet AG)), a clinical
research organization. CEL-SCI initially retained inVentiv Clinical to conduct
the Phase III Clinical Trial of CEL-SCI's investigational drug Multikine*
(Leukocyte Interleukin, Injection). CEL-SCI terminated inVentiv in or about
April 2013 and replaced it with two clinical research organizations, Aptiv
Solutions, Inc. and Ergomed Clinical Research Ltd. CEL-SCI's arbitration claim
is initiated under the Commercial Rules of the American Arbitration Association
alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common
law fraud, and seeks at least $50 million in damages.
About Multikine:
Multikine is a new investigational immunotherapeutic agent that is in a global
Phase III clinical trial as a potential first-line treatment for advanced
primary head and neck cancer. If approved for use following completion of
CEL-SCI's clinical development program for head and neck cancer, Multikine would
be a different type of therapy in the fight against cancer; one that appears to
have the potential to work with the body's natural immune system in the fight
against tumors. The Multikine Phase III study is enrolling patients with
advanced primary, not yet treated, head and neck cancer on 3 continents around
the world. Multikine is intended to create an anti-tumor immune response to
reduce local / regional tumor recurrence and thereby increase the survival of
these patients. CEL-SCI has recently signed a Cooperative Research and
Development Agreement with the US Navy to develop Multikine as a potential
treatment for HIV/HPV co-infected men and women with anal warts. CEL-SCI also
recently signed a co-development agreement with Ergomed Clinical Research for
the development of Multikine for HIV/HPV co-infected women with cervical
dysplasia and another agreement to support the development with the US Navy of
Multikine as a potential treatment for HIV/HPV co-infected men and women with
anal warts. HPV has been shown to be related to some head and neck cancers as
well.
About CEL-SCI Corporation:
CEL-SCI is dedicated to research and development directed at improving the
treatment of cancer and other diseases by utilizing the immune system, the
body's natural defense system. The lead investigational therapy is Multikine
(Leukocyte Interleukin, Injection), currently being studied in a pivotal global
Phase III clinical trial. CEL-SCI is also investigating a different
peptide-based immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1
hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis
(currently in preclinical testing) using its LEAPS technology platform. The
investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing
regions of H1N1 Pandemic Flu (See Journal of Clinical Investigation - J Clin
Invest. 2013; 123(7):2850-2861. doi: 10.1172/JCI67550) Avian Flu (H5N1), and the
Spanish Flu, as CEL-SCI scientists are very concerned about the possible
emergence of a new more virulent hybrid virus through the combination of H1N1
and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna,
Virginia, and in/near Baltimore, Maryland.
* 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 our 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 (Leukocyte Interleukin,
Injection). Further research is required, and early-phase clinical trial
results must be confirmed in the well-controlled, Phase III clinical trial
of this investigational therapy that is currently in progress.
For more information, please visit www.cel-sci.com
When used in this press release, the words "intends," "believes," "anticipated"
and "expects" and similar expressions are intended to identify forward-looking
statements. Such statements are subject to risks and uncertainties which 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 Corporation's SEC filings,
including but not limited to its report on Form 10-K for the year ended
September 30, 2012. 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.