VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American:CVM) announced today 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 $50 million 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.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include, an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K and 10-K/A for the year ended September 30, 2016. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.