CEL-SCI CORPORATION 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.
