CEL-SCI Submits Response To FDA In Connection With Partial Clinical Hold On Phase 3 Clinical Trial

CEL-SCI Corporation (NYSE MKT:CVM) announced today that it has submitted its response to the U.S. Food and Drug Administration (FDA) regarding the previously announced partial clinical hold of CEL-SCI's Phase 3 clinical trial of its investigational drug Multikine* (Leukocyte Interleukin, Injection) in patients with squamous cell carcinoma of the head and neck.

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 immunotherapy, 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. Subject to the partial clinical hold, the study was designed with the objective that, if the study endpoint, which is an 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 (treatment of cervical dysplasia in HIV/HPV co-infected women) has been completed at the University of Maryland. The latter indication (treatment of peri-anal warts in HIV/HPV co-infected men and women) is being studied in a Phase 1 trial at the University of California, San Francisco. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan.

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.

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