CEL-SCI
Corporation (NYSE MKT: CVM) today announced the first
volunteer patient has been enrolled and administered Multikine*
(Leukocyte Interleukin, Injection) in a Institutional Review Board
approved Phase I Clinical Trial evaluating peri-anal wart immunotherapy
in HIV/HPV co-infected men and women at the Naval Medical Center San
Diego (NMCSD). The purpose of this dose escalation study is to evaluate
the safety and impact of Multikine as a treatment of Human Papilloma
Virus associated peri-anal warts and assess the effect on anal
intraepithelial dysplasia (AIN) in HIV/HPV co-infected men and women.
The study is being conducted through a Cooperative
Research and Development Agreement (CRADA) between CEL-SCI
Corporation and Naval Medical Center San Diego. 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. CEL-SCI is contributing doses of the
investigational drug Multikine and will have the right to exclusively
license a new technology developed from the collaboration.
“This is an important milestone in our Phase I trial, which is the third
indication for which Multikine is being evaluated as a potential
immunotherapy. We are pleased to have this working relationship with the
Naval Medical Center San Diego and look forward to completing enrollment
and Multikine administration for the 15 patients planned for this
trial,” stated CEL-SCI Chief Executive Officer Geert Kersten.
Multikine has the potential to improve the clinical treatment of HPV
lesions that are associated with cancer. The NMCSD Clinical
Investigation Department has a robust spectrum of ongoing research with
over 300 Institutional Review Board approved research studies and
clinical trials to advance medical treatment and improving quality of
life for patients.
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 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
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 in
progress at NMCSD is identical to the regimen utilized in the Multikine
cervical study in HIV/HPV co-infected patient volunteers.
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 III clinical trial against head and neck
cancer. If the study endpoint, which is a 10% improvement in overall
survival of the subjects treated with the Multikine regimen as compared
to subjects treated with current standard of care only is satisfied, the
study results will be used to support applications which will be
submitted to regulatory agencies in order to request commercial
marketing approvals for Multikine in major markets around the world.
Additional clinical indications for Multikine which are being
investigated include 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 I trial of the former indication has been completed at
the University of Maryland. The latter indication is now in a Phase I
trial in conjunction with the Naval Medical Center San Diego under a
CRADA (Cooperative Research and Development Agreement).
The CEL-SCI LEAPS technology is also under development for the treatment
of pandemic influenza and as a potential therapeutic vaccine against
rheumatoid arthritis. 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.
Copyright Business Wire 2014