Arizona Cancer Research Alliance & 21st Century Oncology to Enroll Patients in CEL-SCI’s Global Phase III Head & Neck Cance...
April 02 2014 - 8:00AM
Business Wire
Scottsdale site to serve Arizona patients
seeking to enroll in world’s largest Phase III head and neck cancer
trial
CEL-SCI Corporation (NYSE MKT: CVM) today announced it
has expanded its Phase III Head and Neck Cancer clinical trial of
its investigational cancer immunotherapy treatment Multikine*
(Leukocyte Interleukin, Injection) in the U.S. with the addition of
a new site in Scottsdale, Arizona. The 21st Century Oncology clinic
in Scottsdale, along with the Arizona Cancer Research Alliance, has
just joined the study and is actively screening patients for
enrollment into the trial. The Multikine Phase III study is
enrolling patients with advanced primary, not yet treated, head and
neck cancer.
“Our clinical trial is now active in over 40 medical centers
internationally and we are pleased to expand the number of sites in
the U.S. More American patients now have the option of enrolling in
this trial for Multikine, which aims to use the body’s own natural
immune system to fight cancer. We look forward to working with 21st
Century Oncology, and the Arizona Cancer Research Center to bring
the potential of this innovative new method of treating cancer
patients to Arizona,” stated CEL-SCI Chief Executive Officer Geert
Kersten.
The Arizona Cancer Research Alliance (ACRA) is a community-based
network for testing and validating medical interventions with the
potential to diagnose, treat, ameliorate or cure cancer. The
alliance is focused on creating infrastructure to support
physicians who are believed to be responsible for over 80% of the
care provided to patients with cancer.
21st Century Oncology is the largest global, physician-led
provider of integrated cancer care services, operating 166
treatment centers, with 133 centers in 16 states in the U.S. and 33
centers in six Latin American countries.
The Principal Investigator for the Scottsdale site is Dr. Steven
Finkelstein, whose clinical expertise includes radiation oncology,
surgical oncology and clinical immunotherapy in the treatment of
head and neck malignancies, prostate, breast, lung, and colorectal
cancers. Dr. Finkelstein is a Scottsdale Board Certified Radiation
Oncologist, National Director of the Translational Research
Consortium, Adjunct Associate Professor at Translational Genomic
Research Institute, and Executive Director of the Arizona Cancer
Research Alliance.
21st Century Oncology’s Scottsdale clinic is the organization’s
second clinic to join CEL-SCI’s trial as part of the CEL-SCI trial
expansion. CEL-SCI recently announced 21st Century Oncology’s
Greenville, North Carolina site had also joined the study.
About Multikine
Multikine* (Leukocyte Interleukin, Injection) is an
immunotherapeutic agent that is being tested in a global,
multi-center, randomized, controlled, pivotal 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. CEL-SCI
is aiming to complete enrollment of subjects to the Phase III head
and neck cancer study by the end of 2015. The trial is expected to
expand into a total of approximately 100-110 clinical centers in
about 20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA
(Cooperative Research and Development Agreement) with the US Naval
Medical Center, San Diego, to develop Multikine as a potential
treatment for HIV/HPV co-infected men and women with peri-anal
warts. CEL-SCI also announced that it entered into two new
co-development agreements with Ergomed to further the clinical
development of Multikine for cervical dysplasia/neoplasia in women
who are co-infected with HIV and HPV and for peri-anal warts in men
and women who are co-infected with HIV and HPV.
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. Its lead
investigational therapy is Multikine (Leukocyte Interleukin,
Injection), currently being studied in a pivotal global Phase III
clinical trial. CEL-SCI is also investigating an immunotherapy
(LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized
patients and as 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, 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.
For more information, please visit www.cel-sci.com.
* 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.
When used in this report, 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 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, 2013. 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.
CEL-SCI CorporationGavin de Windt, 703-506-9460
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cel Sci (AMEX:CVM)
Historical Stock Chart
From Apr 2023 to Apr 2024