CEL-SCI Corporation announced recently an update on its arbitration with its former clinical research organization (CRO). The last witness in the arbitration hearing testified on Wednesday, November 8, 2017, and no further witnesses or testimony are expected. With that final witness, the testimony phase of the arbitration concluded. All that remains at the trial level are closing statements and post-trial submissions.
In 2013, CEL-SCI filed an arbitration seeking $50M from its former CRO that used to run the Company’s Phase 3 head and neck cancer study with Multikine. CEL-SCI's arbitration claim alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud.
The former CRO was replaced in the spring of 2013 and the Company’s Phase 3 head and neck cancer study has enrolled nine hundred twenty-eight (928) newly diagnosed head and neck cancer patients. All the patients who have completed treatment continue to be followed for protocol-specific outcomes in accordance with the study protocol.
About CEL-SCI Corporation
CEL-SCI's work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases. Its lead investigational immunotherapy, Multikine (Leukocyte Interleukin, Injection), is currently being studied in a pivotal Phase 3 clinical trial as a potential neoadjuvant treatment for patients with squamous cell carcinoma of the head and neck. The study was designed with the objective that, if the study endpoint, which is an improvement in overall survival of the subjects treated with the Multikine treatment regimen plus the current standard of care (SOC) as compared to subjects treated with the current SOC only, is satisfied, the study results will be used to support applications that the Company plans to submit to regulatory agencies in order to seek commercial marketing approvals for Multikine in major markets around the world. The Company’s LEAPS technology is being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. CEL-SCI has patents on Multikine from the US, Europe, China, and Japan.
The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
SOURCE: CEL-SCI Corporation