Cel-Sci Corporation (NYSE American: CVM), is a biotechnology company that tests drugs for the treatment of cancer, autoimmune and infectious diseases through the research and development of immunotherapy products.
Cel-Sci's main product is the drug Multikine, an immunotherapeutic agent designed to fight cancer by stimulating the body's immune system.
[3][4] In January 2007, the US cleared the Phase 3 trial and Multikine was designated as an orphan drug by the FDA for neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
This order stated that from August 1988 through June 1991, de Clara was 2–31 weeks late to file 16 forms documenting his sales of over $2.6 million of Cel-Sci stock.
The arbitrator awarded Cel-Sci $2.9 million in damages because the CRO failed to enroll the required number of patients over a period of 2 years, thus delaying the clinical development of Multikine.
[21][22][23] In 1996, The Washington Post reported that the company was conducting its testing without the backing of the FDA because they couldn't agree on study details with said regulatory organization.