CEL-SCI Expands Its Phase I Study for Treatment of Anal Warts in HIV/HPV Co-Infected Patients with Addition of 2nd Site at Un...
July 20 2015 - 8:30AM
Business Wire
Renowned Key Opinion Leader, Dr. Joel
Palefsky, to serve as Principal Investigator at the site
CEL-SCI Corporation (NYSE MKT: CVM) (“CEL SCI” or the
“Company”) today announced it has added a second clinical site for
its Phase I clinical trial evaluating peri-anal wart immunotherapy
in HIV/HPV co-infected men and women with its investigational
cancer immunotherapy Multikine* (Leukocyte Interleukin, Injection).
Dr. Joel Palefsky, world renowned scientist and Key Opinion Leader
(KOL) in human papilloma virus (HPV) research and the prevention of
anal cancer, has joined the study as a Principal Investigator at
the University of California San Francisco (UCSF). UCSF becomes the
second clinical site for the study. The first site, the U.S. Naval
Medical Center San Diego, continues to enroll patients under a
Cooperative Research and Development Agreement (CRADA).
Dr. Joel Palefsky is the Chair of the HPV Working Group of the
AIDS Malignancy Consortium (AMC) and is the head of the AMC HPV
Virology Core Lab at UCSF. The AMC is a U.S. National Cancer
Institute-supported clinical trials group founded in 1995 to
support innovative trials for AIDS-related cancers. The AMC is
composed of over 37 clinical trials sites worldwide, five Working
Groups, an Administrative Office, a Statistical Office, and an
Operations and Data Management Office. Collectively, these
components develop and oversee the scientific agenda, manage the
groups’ portfolio of clinical trials and other scientific-based
studies, and help to develop new protocols. Dr. Palefsky has
extensive experience in the biology of HPV infection, HPV infection
in HIV-positive men and women, HPV vaccines and in the design and
implementation of multiple clinical research trials of HPV-related
disease.
Having published over 280 papers, Dr. Palefsky is Principal
Investigator of the ANCHOR study, an $89 million NIH-funded study
of the efficacy of secondary prevention of anal cancer. He is also
the Principal Investigator on several laboratory-based and clinical
research studies of HPV-associated neoplasia, particularly in the
setting of HIV infection. He also specializes in the molecular
biology and development of new treatments for HPV. Dr. Palefsky is
the founder and immediate past president of the International Anal
Neoplasia Society and is currently president of the International
Human Papillomavirus Society. He is actively involved in training
students in clinical and translational research. Dr. Palefsky has
led the Doris Duke Charitable Foundation (DDCF) program at UCSF
since its inception in 2001 and has been the leader of the Clinical
Translational Science Awards (CTSA) TL1 program at UCSF since its
inception in 2006.
“We are very pleased to welcome Dr. Palefsky as a Principal
Investigator for our Phase I study and we believe his interest in
Multikine is a very important testament of our immunotherapy’s
potential in the treatment of HPV related diseases in HIV infected
patients,” stated CEL-SCI Chief Executive Officer Geert Kersten.
“Dr. Palefsky is widely recognized as one of the world’s top
researchers in the field HPV infection in HIV co-infected patients.
With his participation through UCSF we anticipate rapid patient
enrollment in our Phase I study.”
Anal and genital warts are commonly associated with 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 have
difficulty clearing HPV due to their compromised immune system.
About Multikine for HIV/HPV Co-infected Patients
Multikine is being given to 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 immunotherapy Multikine was given to HIV/HPV
co-infected women with cervical dysplasia. In these patients,
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 utilized in
the Multikine cervical study in HIV/HPV co-infected patient
volunteers is identical to the regimen being administered in the
current Phase I study of HIV/HPV co-infected patient volunteers
with peri-anal warts that is in progress at the U.S. Naval Medical
Center San Diego and the University of California San
Francisco.
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 therapy, 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. If the study
endpoint, which is a 10% 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 has been
completed at the University of Maryland.
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. For more information, please visit
www.cel-sci.com.
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
Corporation’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, 2014. 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 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 have 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 Phase 3 clinical trial of
this investigational therapy that is currently in progress.
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CEL-SCI CorporationGavin de Windt, 703-506-9460
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