0001004878-17-000054.txt : 20170307
0001004878-17-000054.hdr.sgml : 20170307
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
8-K
1
form8kfdaresp3-17.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): 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
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
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
EX-99
2
form8kitem801ex99march-17.txt
EXHIBIT 99
EXHIBIT 99
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
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.