CEL-SCI Corporation (NYSEMKT:CVM) shares were up 6.31% to $0.452 on Tuesday and flat in after-hours trading. The company has a market cap of $75.42 million at 155.46 million shares outstanding. Share prices have been trading in a 52-week range of $0.33 to $0.75.
CEL-SCI Corporation is a company that is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. It is focused on activating the immune system to fight cancer and infectious diseases and operates through the segment of research and development of certain drugs and vaccines.
The company is currently focused on the development of Multikine, which is an investigational immunotherapy under development for treatment of certain head and neck cancers, and anal warts or cervical dysplasia in human immunodeficiency virus and human papillomavirus co-infected patients and Ligand Epitope Antigen Presentation System technology. This is done through investigational therapies, LEAPS-H1N1-DC, CEL-2000 and CEL-4000.
In its press release, CEL-SCI Corporation announced that it has received verbal notice from the U.S. Food and Drug Administration that its Multikine Phase 3 clinical trial in advanced primary head and neck cancer has been placed on clinical hold. Still, patients currently receiving study treatments can continue to receive treatment. Apart from that, patients who have already been enrolled in the study can also be followed. This study has approximately 900 patients enrolled.
For now, CEL-SCI Corporation was also told to expect a formal letter from the FDA within 30 days. The company will work with the FDA to obtain the release of the clinical hold. The study endpoint is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care compared to subjects treated with the current standard of care. CEL-SCI Company has issued patents on Multikine from the US, Europe, China and Japan.
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