CEL-SCI Corporation (NYSEMKT:CVM) shares were up 7.43% to $0.113 on Monday and down to $0.111 in after-hours trading. Share prices have been trading in a 52-week range of $0.06 to $0.66. The company has a market cap of $22.46 million at 200.97 million shares outstanding.
In a press release, CEL-SCI Corporation shed some light on the FDA partial clinical hold on Phase 3 head and neck cancer study involving its investigational drug Multikine. With this clinical hold, patients currently receiving study treatments can continue to receive treatment at the discretion of their physicians and with their consent, and patients already enrolled in the study will continue to be followed.
The company had a Type A face-to-face meeting with the FDA to have an open and frank discussion of the clinical hold issues raised and secure the agency’s input and clarification on how to address the partial hold issues. They came up with two action steps:
- Provide an updated Investigator’s Brochure and current procedures for compliance with requirements under 21 CFR 312 Subpart D to address the partial clinical hold.
- Provide a list of major protocol deviations, which CEL-SCI believes will affect study results, and provide a plan to identify major protocol deviations across all patients enrolled in the Phase 3 protocol.
The company ensure that it is working diligently to respond to these action items and that it is giving the FDA issues top priority.
“It is our belief that addressing the Action Items listed above will support a favorable decision by the FDA to lift the partial clinical hold. While we think that we have understood the Action Items, it is possible that we have not understood all issues involved. All of our work is subject to the FDA’s review of our submission upon its completion and may or may not result in the lifting of the partial clinical hold,” the statement concluded.
CEL-SCI Corporation is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. The company is focused on activating the immune system to fight cancer and infectious diseases. It operates through the segment of research and development of certain drugs and vaccines.
CEL-SCI Corporation is focused on the development of Multikine (Leukocyte Interleukin, Injection), 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 (L.E.A.P.S.) technology, with over two investigational therapies, LEAPS-H1N1-DC, a product candidate under development for treatment of pandemic influenza in hospitalized patients, and CEL-2000 and CEL-4000, vaccine product candidates under development for treatment of rheumatoid arthritis.