CEL-SCI Announces Cooperative Research and Development Agreement (CRADA) for Multikine with US Navy

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CEL-SCI Announces Cooperative Research and Development Agreement (CRADA) for Multikine with US Navy

VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE MKT:CVM) today announced that it has signed a Cooperative Research and Development Agreement (CRADA) with the Naval Medical Center, San Diego. Pursuant to this agreement, the US Naval Medical Center, San Diego will conduct a Human Subjects Institutional Review Board approved Phase I dose escalation study of CEL-SCI's investigational immunotherapy Multikine (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI will contribute the investigational study drug Multikine and will retain all rights to any currently owned technology and will have the right to exclusively license any new technology developed from the collaboration. CEL-SCI is supporting the project by providing Multikine and funding for laboratory studies.

Anal and genital warts are commonly associated with the Human Papilloma Virus, the most common sexually transmitted disease. Men and women with a history of anogenital warts have a 30 fold increased risk of anal cancer. Persistent HPV infection in the anal region is thought to be responsible for up to 80% of anal cancers. HPV is a significant health problem in the HIV infected population as individuals are living longer as a result of greatly improved HIV medications.

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. Five participants will be treated with Multikine injections around the peri-anal warts at the lower dose for 5 days/week for 2 weeks, off 2 weeks, then 5 days per week for two more 2 weeks. If no serious adverse events are noted, 10 more patients will receive the higher dose of Multikine in the same manner. The study is open to adult HIV positive men and women that are eligible for medical care from the Naval Medical Center San Diego.

Multikine is being given to the HIV/HPV co-infected patients with peri-anal warts because promising early results were seen in another Institutional Review Board approved Multikine Phase I study conducted at the University of Maryland. In this study, investigational therapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia resulting in visual and histological evidence of clearance of lesions. Furthermore, elimination of a number of HPV strains was determined by in situ polymerase chain reaction (PCR) performed on tissue biopsy collected before and after Multikine treatment. As reported by the study investigators, the study volunteers all appeared to tolerate the 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 Naval Medical Center San Diego will be identical to the regimen that was used in the Multikine cervical study in HIV/HPV co-infected patient volunteers.

The Naval Medical Center San Diego, 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. The Principle Investigator on this Phase I study is John D. Malone MD, MPH, Infectious Diseases Staff Physician, Naval Medical Center San Diego. This Cooperative Research and Development Agreement to assess Multikine Immunotherapy in HIV/HPV co-infected volunteers with peri-anal warts will be beneficial to advance clinical medicine. 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.


Multikine, is an immunotherapeutic agent that is in a global 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. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on 3 continents around the world. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients. HPV has been shown to be related to some head and neck cancers as well.

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. The lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating a different peptide-based immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and 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 (See Journal of Clinical Investigation - J Clin Invest. 2013; 123(7):2850-2861. doi: 10.1172/JCI67550) 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.

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.

For more information, please visit www.cel-sci.com.

When used in this report, 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, 2012. 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 Corporation
Gavin de Windt, 703-506-9460

KEYWORDS:   United States  North America  Virginia


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