0001004878-17-000254.txt : 20171212
0001004878-17-000254.hdr.sgml : 20171212
20171212125759
ACCESSION NUMBER: 0001004878-17-000254
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 3
CONFORMED PERIOD OF REPORT: 20171207
ITEM INFORMATION: Other Events
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20171212
DATE AS OF CHANGE: 20171212
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: 171251349
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
form8k801prsrls12-17.txt
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): December 7, 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))
Indicate by check mark whether the registrant is an emerging growth company as
defined in Rule 405 of the Securities Act of 1933 (ss.203.405 of this chapter)
or Rule 12b-2 of the Securities Exchange Act of 1934 (ss.204.12b-2 of this
chapter.
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has
elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the
Exchange Act. [ ]
1
Item 8.01 Other Events
On December 7, 2017, the Company issued a press release, filed as Exhibit
99.1, concerning the observations and recommendations the Independent Data
Monitoring Committee (IDMC) for the Company's Phase 3 head and neck cancer study
of Multikine.
The IDMC:
a) saw no evidence of any significant safety questions, and
b) recommended that the Company continue the study.
On December 11, 2017, the Company issued a press release, filed as Exhibit
99.2, announcing that no further enrollment was required for the Company's Phase
3 head and neck cancer study of Multikine.
Item 9.01 Exhibits
Exhibit
Number Description of Document
------ -----------------------
99.1 December 7, 2017 press release
99.2 December 11, 2017 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: December 12, 2017
CEL-SCI CORPORATION
By: /s/ Patricia B. Prichep
-----------------------------------
Patricia B. Prichep
Senior Vice President of Operations
EX-99
2
form8k801ex991dec-17.txt
EXHIBIT 99.1
EXHIBIT 99.1
8229 Boone Boulevard, Suite 802 COMPANY CONTACT:
Vienna, VA 22182. placecountry-regionUSA Gavin de Windt
Telephone (703) 506-9460 CEL-SCI Corporation
www.cel-sci.com (703) 506-9460
CEL-SCI REPORTS RECENT DATA REVIEW BY THE INDEPENDENT DATA MONITORING
COMMITTEE FOR ITS PIVOTAL PHASE 3 HEAD AND NECK CANCER STUDY
VIENNA, VA, December 7, 2017 -- CEL-SCI Corporation (NYSE American: CVM)
announced today that the Independent Data Monitoring Committee (IDMC) for the
Company's pivotal Phase 3 head and neck cancer study of its investigational
immunotherapy Multikine* (Leukocyte Interleukin, Injection) has completed its
review of the Phase 3 study data. The data from all 928 enrolled patients were
provided to the IDMC by the clinical research organization (CRO) responsible for
data management of this Phase 3 study.
The IDMC made the following observation and recommendation:
a) The IDMC saw no evidence of any significant safety questions.
b) The IDMC recommends continuing the study.
IDMCs are committees commonly used by sponsors of clinical trials to protect the
interests of the patients and the integrity of the study data in ongoing trials,
especially when the trials involve patients with life threatening diseases, and
when, as in cancer clinical trials, they extend over long periods of time. About
CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. When it comes to cancer
immunotherapy, CEL-SCI believes it is most logical to boost the patient's immune
system while it is still intact in order to have the greatest possible impact on
survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head
and neck cancer with its lead investigational immunotherapy Multikine, BEFORE
they have received surgery, radiation and/or chemotherapy. This approach is
unique. Most other cancer immunotherapies are used only after conventional
therapies have been tried and/or failed. Head and neck cancer represents about
6% of all cancers. Multikine has received Orphan Drug designation from the FDA
for the treatment of head and neck cancer patients with advanced squamous cell
carcinoma.
The Company's LEAPS technology is being developed as a therapeutic vaccine for
rheumatoid arthritis and is supported by grants from the National Institutes of
Health. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan.
The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
1
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
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.
EX-99
3
form8k801ex992dec-17.txt
EXHIBIT 99.2
EXHIBIT 99.2
8229 Boone Boulevard, Suite 802 COMPANY CONTACT:
Vienna, VA 22182. placecountry-regionUSA Gavin de Windt
Telephone (703) 506-9460 CEL-SCI Corporation
www.cel-sci.com (703) 506-9460
CEL-SCI REACHES FULL ENROLLMENT IN PIVOTAL PHASE 3 HEAD AND NECK CANCER STUDY
Major Milestone Achieved in World's Largest Head and Neck Cancer Phase 3 Study
VIENNA, VA, December 11, 2017 -- CEL-SCI Corporation (NYSE American: CVM)
announced today that no further patient enrollment is required in the pivotal
Phase 3 head and neck cancer study of its investigational immunotherapy
Multikine* (Leukocyte Interleukin, Injection). The accrual and treatment phases
of this Phase 3 study are complete. All of the 928 enrolled patients in the
study are being followed-up as required by the study protocol.
CEL-SCI recently announced that the study's Independent Data Monitoring
Committee (IDMC) completed its most recent review of the data from all 928
patients enrolled in the study, and recommended continuing the study as there
was no evidence of any significant safety questions.
The primary endpoint of the study, a 10% improvement in overall survival of the
Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care
alone, will be determined after a total of 298 deaths have occurred in these two
main comparator arms of the study and have been recorded in the study database.
The last patient was enrolled in the study in September 2016. Approximately 135
patients were enrolled in the study from 2011 to 2013, about 195 were enrolled
in 2014, about 340 in 2015, and about 260 in 2016. The study protocol assumed an
overall survival rate of about 55% at 3 years for the SOC treatment group alone.
IDMCs are committees commonly used by sponsors of clinical trials to protect the
interests of the patients and the integrity of the study data in ongoing trials,
especially when the trials involve patients with life threatening diseases, and
when, as in cancer clinical trials, they extend over long periods of time.
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. When it comes to cancer
immunotherapy, CEL-SCI believes it is most logical to boost the patient's immune
system while it is still intact in order to have the greatest possible impact on
survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head
and neck cancer with Multikine BEFORE they have received surgery, radiation
and/or chemotherapy. This approach is unique. Most other cancer immunotherapies
1
are used only after conventional therapies have been tried and/or failed. Head
and neck cancer represents about 6% of all cancers. Multikine has received
Orphan Drug designation from the FDA for the treatment of head and neck cancer
patients with advanced squamous cell carcinoma.
The Company's LEAPS technology is being developed as a therapeutic vaccine for
rheumatoid arthritis and is supported by grants from the National Institutes of
Health. CEL-SCI has patents on Multikine from the U.S., Europe, China, and
Japan.
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
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.