CEL-SCI
Corporation (NYSE MKT: CVM) announced today the Institutional
Review Board (IRB) of the U.S. Navy’s Naval
Medical Center San Diego (NMCSD), has
approved the start of a Phase I dose escalation study of the Company’s
investigational immunotherapy Multikine* (Leukocyte Interleukin,
Injection) in HIV/HPV
co-infected men and women with peri-anal warts. This approval marks
the third indication for which Multikine is being investigated in
clinical trials. Multikine is currently being investigated in the
largest Phase III trial in the world for the treatment of head and neck
cancer. It has previously been evaluated as a potential treatment for
cervical dysplasia in HIV/HPV co-infected women and a Phase II study to
further investigate this indication is currently in the planning stages.
The Phase I dose escalation study is being funded and conducted through
a Cooperative Research and Development Agreement (CRADA) between the
U.S. Navy and CEL-SCI. CEL-SCI will contribute the investigational
immunotherapy drug Multikine, will retain all rights to any currently
owned technology and will have the right to exclusively license any new
technology developed from the collaboration. By entering into this
CRADA, NMCSD does not directly or indirectly endorse any product or
service provided, or to be provided, by CEL-SCI, its successors,
assignees, or licensees.
Anal and genital warts are commonly associated with the Human Papilloma
Virus (HPV), the most common sexually transmitted disease. The U.S.
Center for Disease Control and Prevention (CDC) has named HPV the 4th
largest health threat the U.S. will face in 2014. According to the CDC,
360,000 people in the U.S. get genital warts each year. Persistent HPV
infection in the anal region is thought to be responsible for up to 80%
of anal cancers. HPV is an even more significant health problem in the
HIV infected population as individuals are living longer as a result of
greatly improved HIV medications, but are mostly unable to clear HPV due
to their weakened immune system.
The Principle Investigator for the Phase I study is John D. Malone MD,
MPH, Infectious Diseases Staff Physician, NMCSD. The purpose of this
dose escalation study is to evaluate the safety and clinical impact of
Multikine as a treatment of peri-anal warts and assess the effect on
anal intraepithelial dysplasia (AIN) in HIV/HPV co-infected men and
women.
According to Dr. Malone, the immunologic agent Multikine has potential
to improve the clinical treatment of HPV lesions that are associated
with cancer. The NMCSD Clinical Investigation Department has a robust
spectrum of research ongoing, participating in over 400 research
studies/trials annually with the hope of advancing medical treatment and
improving quality of life for patients.
NMCSD, a referral center of excellence for HIV/AIDS care of active duty,
family members, and retired individuals since the start of the HIV
epidemic in the 1980s, has conducted over 30 HIV/AIDS human subjects
approved clinical research protocols to advance clinical patient care.
Multikine is being given to the HIV/HPV co-infected patients with
peri-anal warts based on the results obtained in a Multikine Phase I
study conducted at the University of Maryland in which the
investigational therapy Multikine was given to HIV/HPV co-infected women
with cervical dysplasia. In these subjects visual and histological
evidence of clearance of lesions was observed. Elimination of a number
of HPV strains was also determined by in situ polymerase chain reaction
(PCR) performed on tissue biopsy collected before and after Multikine
treatment. The study investigators reported that the study volunteers in
this study all appeared to tolerate the Multikine treatment with no
reported serious adverse events. The treatment regimen for the study of
up to 15 HIV/HPV co-infected patient volunteers with peri-anal warts to
be conducted by NMCSD will be identical to the regimen that was used in
the Multikine cervical study in HIV/HPV co-infected patient volunteers.
“Anal warts have become an increasing problem in the general population.
Patients with anal warts who are co-infected with HIV/HPV have a 30-fold
increased risk of developing anal cancer because their immune system is
compromised,” stated CEL-SCI Chief Executive Officer Geert Kersten.
“Though this disease appears to be completely unrelated to head and neck
cancer, our current Phase III lead indication, HPV has been implicated
as a potential causative agent in both diseases. The virus is now
thought to be a cause of many head and neck cancers, particularly in
younger people in the U.S. In the anal warts study being conducted we
hope to repeat the promising results seen in the study with HIV infected
women with cervical dysplasia where we saw the elimination of many HPV
strains following Multikine treatment,” Geert Kersten added.
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 its 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 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, 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.
Copyright Business Wire 2014