CEL-SCI Corporation (NYSEMKT:CVM) Addresses FDA Partial Clinical Hold


CEL-SCI Corporation (NYSEMKT:CVM) shares were up 7.43% on Monday to $0.113 and down 1.60% in after-hours trading to $0.111. The company has a market cap of $22.46 million at 200.97 million shares outstanding. Share prices have been trading in a 52-week range of $0.06 to $0.66.

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. It operates through the segment of research and development of certain drugs and vaccines.

In particular, the company is focused on the development of Multikine (Leukocyte Interleukin, Injection), 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 (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.

In a press release this week, CEL-SCI Corporation shared that it has received the official minutes from its February 8, 2017 meeting with the U.S. Food and Drug Administration regarding the partial clinical hold placed on the Phase 3 head and neck cancer study involving Multikine. Under this partial clinical hold, patients currently receiving study treatments can continue to receive treatment at the discretion of their physicians and with their consent. Also, patients already enrolled in the study will continue to be followed.

During the meeting with the FDA, CEL-SCI Corporation was allowed an open and frank discussion of the clinical hold issues raised in order to gain input and clarification on how to address the partial hold issues. Here are some of the action items discussed:

First is to 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. Next is to 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 has ensured that it is working diligently to complete these action items.

The press release emphasized that CEL-SCI Corporation 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,” it concluded.

DISCLAIMER: There is a substantial risk of loss with any speculative asset, especially small cap stocks. The opinions expressed are those of the author, and do not constitute recommendations to buy or sell a stock. Do your own research before committing capital.