CEL-SCI Corporation
CEL-SCI Corporation (NYSE American: CVM), is a biotechnology company that treats cancer, autoimmune and infectious diseases through the research and development of immunotherapy products. CEL-SCI has operations in Vienna, Virginia and Baltimore, Maryland. It is currently in Phase III of Clinical Trials with the Federal Drug Administration (FDA).
History
CEL-SCI Corporation was founded by Maximilian de Clara in in 1983 in Germany who was also the president of the company until 2016 when he resigned.
CEL-SCI's main product and existence are based on a drug called Multikine, which is a immunotherapeutic agent to fight cancer by stimulating the body's immune system. In Phase II testing of patients with head and neck cancer in the early 2000s, Multikine demonstrated tumor-reducing ability.
LEAPS (Ligand Epitope Antigen Presentation System) technology, is another Cel-Sci product which is currently being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health.
CEL-SCI is testing its Phase III clinical trial in head and neck cancer that is the idea to boost the immune system before surgery, chemotherapy, and radiation because that is when the immune system is strongest. The Phase III clinical trial enrolled 928 patients and is the largest ever head and neck cancer trial.
In January 2007, the US cleared the Phase 3 trial and Multikine was designated as an orphan drug by the FDA for the orphan population of neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
In 2018, CEL-SCI won a 4.5-year-long arbitration suit filed in October 2013 against CRO for breach of contract. The arbitrator awarded CEL-SCI $2.9 million in damages because the CRO was failed to enroll required number of patients over the period of 2 years that delayed clinical development of Multikine. Later, the arbitration resolution allowed CEL-SCI to focus and continue to the Phase III primary head and neck cancer study by lifting the FDA clinical hold imposed in August 2017.
In 2019, an avid shareholder of CEL-SCI created the due diligence site KillCVMShorts.com which has infuriated the Shorts.
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History
CEL-SCI Corporation was founded by Maximilian de Clara in in 1983 in Germany who was also the president of the company until 2016 when he resigned.
CEL-SCI's main product and existence are based on a drug called Multikine, which is a immunotherapeutic agent to fight cancer by stimulating the body's immune system. In Phase II testing of patients with head and neck cancer in the early 2000s, Multikine demonstrated tumor-reducing ability.
LEAPS (Ligand Epitope Antigen Presentation System) technology, is another Cel-Sci product which is currently being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health.
CEL-SCI is testing its Phase III clinical trial in head and neck cancer that is the idea to boost the immune system before surgery, chemotherapy, and radiation because that is when the immune system is strongest. The Phase III clinical trial enrolled 928 patients and is the largest ever head and neck cancer trial.
In January 2007, the US cleared the Phase 3 trial and Multikine was designated as an orphan drug by the FDA for the orphan population of neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
In 2018, CEL-SCI won a 4.5-year-long arbitration suit filed in October 2013 against CRO for breach of contract. The arbitrator awarded CEL-SCI $2.9 million in damages because the CRO was failed to enroll required number of patients over the period of 2 years that delayed clinical development of Multikine. Later, the arbitration resolution allowed CEL-SCI to focus and continue to the Phase III primary head and neck cancer study by lifting the FDA clinical hold imposed in August 2017.
In 2019, an avid shareholder of CEL-SCI created the due diligence site KillCVMShorts.com which has infuriated the Shorts.
Reference
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