VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
Dear Fellow Shareholders,
We expect two very important events for our Company: 1) we anticipate a final resolution this month of the ongoing arbitration brought by CEL-SCI against its former contract research organization (CRO) for its pivotal Phase 3 head and neck cancer trial and 2) the final read-out of our pivotal Phase 3 head and neck cancer trial.
Closing arguments in the arbitration suit against the former CRO were concluded on April 25, 2018, and the arbitrator indicated he would render his judgement in the matter within 60 days of the conclusion of closing arguments. Accordingly, by June 24, 2018 we expect a decision from the arbitrator. CEL-SCI filed the arbitration suit against its former CRO in October 2013. CEL-SCI's arbitration claim alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud.
Working with two new CROs for our pivotal Phase 3 head and neck cancer study, we completed full enrollment of 928 patients in the largest Phase 3 trial in the world for head and neck cancer. The last patient was enrolled in the study in September 2016. Based on overall survival data available in the scientific literature for the study's patient population we believe that the end of the Phase 3 trial is approaching. We are now following the study subjects per the Protocol. When 298 events (deaths) have occurred in the two main comparator arms of the study and the corresponding data have been recorded in the study database, we will be able to analyze the data for the primary efficacy and other study endpoints. At this time, we are unable to provide a more precise indication of when the Phase 3 study may end because we are unable to predict when the cancer patients enrolled in the study will die. Once a sufficient number of events (deaths) have occurred, this will put us in a position to assess our primary endpoint based on the study’s overall survival data. Should the study meet its primary efficacy endpoint of 10% improvement in overall survival, CEL-SCI plans to apply for regulatory approval in major markets including the United States and the European Union.
The U.S. Patent Office has recently allowed two new patents for our LEAPS (Ligand Epitope Antigen Presentation System) vaccine platform technology for methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides. The patents allowed are:
- "Method for Inducing an Immune Response and Formulations Thereof"
- "Method for Inducing an Immune Response against avian, swine, Spanish, H1N1, H5N9 influenza viruses and formulations"
Our LEAPS platform technology is currently advancing with the support of a $1.5 million grant from the U.S. National Institutes of Health (NIH) to develop CEL-4000, our rheumatoid arthritis candidate treatment vaccine, the first product based on our LEAPS platform. Data from pre-clinical studies currently being conducted will be used in support of an Investigational New Drug (IND) application we plan to file for the treatment of Rheumatoid Arthritis (in humans) with the FDA for CEL-4000.
We thank you for your continued support of our Company and we look forward to informing you as material events occur.
Sincerely,
Geert Kersten
Chief Executive Officer
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. The Phase 3 study is fully enrolled with 928 patients. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient’s immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, in CEL-SCI’s pivotal Phase 3 study patients who are newly diagnosed with advanced head and neck cancer are treated first with its lead investigational immunotherapy Multikine (Leukocyte Interleukin, Injection), BEFORE they receive surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. CEL-SCI has received patents for Multikine from the US, Europe, China and Japan.
The Company’s LEAPS technology is currently being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
Forward-Looking Statements
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 for the year ended September 30, 2017. 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.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
