Date: 2015-07-20
Type of information: update on patient enrollment
phase: 1-2
Announcement: update
Company: Cell-Sci Corporation (USA - VA)
Product: Multikine® (Leukocyte Interleukin, Injection)
Action
mechanism: protein/cytokine. Multikine® is a patented defined mixture of biologically active, natural cytokines that simulate the body’s healthy immune response. The cytokine mixture includes interleukins, interferons, chemokines, and colony-stimulating factors. This combination immunotherapy is administered prior to any other cancer therapy because that is the period when the anti-tumor immune response can still be fully activated. This immunotherapeutic agent is developed under a licensing agreement with Teva.
Disease: Human Papilloma Virus associated peri-ana wart immunotherapy in HIV/HPV co-infected men and women
Therapeutic area: Infectious diseases
Country: USA
Trial details:
Latest
news: * On July 20, 2015, CEL-SCI Corporation 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. * On September 29, 2014, CEL-SCI Corporation 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. 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.
