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CEL-SCI Reports CRADA with Naval Medical Center in San Diego

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CEL-SCI Corporation (NYSE: 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.

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