By a News Reporter-Staff News Editor at AIDS Vaccine Week -- CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") announced that during the month of January it has enrolled 29 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer. Total patient enrollment for the trial is now 697 as of January 31, 2016 in the world's largest Phase 3 study in head and neck cancer (see also CEL-SCI Corporation).
"Enrollment this month was impacted by the Christmas and Orthodox Christmas holidays. We expect enrollment to increase again in the coming months," stated CEL-SCI CEO Geert Kersten.
The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries. About the Multikine Phase 3 Study The Multikine Phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only. About Multikine Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that is given BEFORE surgery, radiation and chemotherapy because that is when the immune system is thought to be the strongest, one that appears to have the potential to work with the body's natural immune system in the fight against tumors.
Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.
CEL-SCI has also entered into two additional co-development agreements for up to $3 million each with Ergomed Clinical Research Limited to further the development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV. 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 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. If the study endpoint, which is a 10% improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. Additional clinical indications for Multikine that are being investigated include the treatment of 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 1 trial of the former indication has been completed at the University of Maryland. The latter indication is now in a Phase 1 trial in conjunction with the U.S. Naval Medical Center, San Diego, under a CRADA and UCSF.
CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis.
Keywords for this news article include: Warts, HIV/AIDS, Hospital, Oncology, Virology, Cytokines, Dysplasia, Immunology, Leukocytes, Anal Cancer, DNA Viruses, Dermatology, RNA Viruses, Interleukins, Retroviridae, Immune System, HIV Infections, Cancer Vaccines, Vertebrate Viruses, CEL-SCI Corporation, Risk and Prevention, Viral Skin Diseases, DNA Virus Infections.
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