By a News Reporter-Staff News Editor at AIDS Vaccine Week -- CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") announces that it has been granted a European patent on Multikine (Leukocyte Interleukin, Injection), its investigational Phase 3 cancer immunotherapy. The patent, number EP 1 753 452 B, is entitled: A METHOD FOR ALTERING THE CD4/CD8 RATIO AND THE MONONUCLEAR CELLULAR INFILTRATE INTO A TUMOR (see also CEL-SCI Corporation).
The patent is important because it recites a mechanism of action of Multikine by which Multikine changes the type of T cells that enter the tumor microenvironment. This change results in the tumor becoming "visible" to the immune system, resulting in a robust and sustainable anti-tumor immune response.
Positive results with Multikine in earlier clinical studies confirmed by pathology were published. An ongoing Phase 3 clinical trial against advanced primary (not yet treated) head and neck cancer is progressing rapidly. The study is ongoing in 24 countries and so far has enrolled over 600 patients. In October 2015 the clinical research organization that runs the study added $2 million to its co-development investment in the Phase 3 study. Their investment of $12 million will only be repaid from a successful drug. 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 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: Patents, HIV/AIDS, Hospital, Oncology, Virology, Cytokines, Dysplasia, Immunology, Leukocytes, Anal Cancer, Dermatology, RNA Viruses, Interleukins, Retroviridae, Immune System, Immunotherapy, HIV Infections, Cancer Vaccines, Immunomodulation, Clinical Research, Vertebrate Viruses, CEL-SCI Corporation, Risk and Prevention.
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