- CEL-SCI Corporation (NYSE:CVM) announces that it has received verbal notice from the FDA that its Multikine (Leukocyte Interleukin Injection) Phase 3 clinical trial in advanced primary head and neck cancer has been placed on clinical hold. The company expects to receive a formal letter within 30 days and will work diligently to address the matter. The specific reasons for the hold are not provided. The study currently has about 926 patients enrolled.
- A full clinical hold means that no new patients can be recruited into the study and all dosing must cease. Patients currently enrolled can continue to be followed.
- The primary endpoint of the study is overall survival over a three-year period. According to ClinicalTrials.gov, the estimated study completion date is December 2017.
- CEL-SCI is also developing its pre-clinical L.E.A.P.S. (Ligand Epitope Antigen Presentation System) technology for the potential treatment of pandemic influenza in hospitalized patients and as a potential vaccine for the treatment of rheumatoid arthritis.
- Shares are down 13% premarket on light volume.