VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
Dear Fellow Shareholders:
CEL-SCI enters 2018 in a position of strength and hope for the year ahead. We thank all of our shareholders for supporting our Company during a difficult 2017. I am pleased to report where we stand today with the items that have the most significant impact on our Company’s value:
- Our Phase 3 trial in head and neck cancer is fully enrolled. All that remains is to monitor patients and determine if our trial has met its primary endpoint of improving overall survival of Multikine* (Leukocyte Interleukin, Injection) treated patients following 298 events in the two main groups. We continue to believe that boosting a cancer patient’s immune system before surgery, radiation and chemotherapy makes the most sense because that is the time when the immune system is thought to be strongest.
- In October 2013 we filed an arbitration suit seeking at least $50 million against the clinical research organization (CRO) that was originally contracted to managed our phase 3 trial in head and neck cancer patients and which was subsequently replaced by us. This arbitration finally completed its testimony phase in early November 2017. We are now working on post-trial submissions and closing statements to bring this arbitration to conclusion and finally allow the arbitrator to reach and issue a final decision.
- With a new $1.5 million grant from the National Institutes of Health, we are moving our LEAPS rheumatoid arthritis vaccine forward towards filing an Investigational New Drug application. Data regarding the vaccine were presented at numerous scientific conferences throughout 2017.
Full Enrollment Achieved in Phase 3 Head and Neck Cancer Study for Multikine
We began 2017 with the pivotal Phase 3 trial of our investigational immunotherapy Multikine on clinical hold with the U.S. Food and Drug Administration (FDA). Following a thorough review of the study protocol, its management, and the study data, the FDA removed the clinical hold in August 2017. When the hold was imposed on the study at the end of September 2016, 928 patients had already been accrued to the study. During the clinical hold period we continued to follow up all enrolled patients per the protocol.
Very recently, in December 2017, our Phase 3 study’s Independent Data Monitoring Committee (IDMC) completed its review of the Phase 3 study data. The data from all 928 enrolled patients were provided to the IDMC by the CRO responsible for data management of this Phase 3 study. The IDMC saw no evidence of any significant safety question and recommended continuing the study.
Following the IDMC’s review, we determined that the study is fully enrolled with 928 patients. When the clinical hold was placed by the FDA they specified that no additional patients could be enrolled. The FDA clinical hold therefore did not stall the study’s progress as we had achieved full enrollment prior to the FDA’s hold.
We are proud of achieving a major milestone by completing enrollment in what we believe is the world’s largest Phase 3 study in advanced primary head and neck cancer. This patient population and disease indication desperately need a new approach since it has been over 60 years since the FDA has approved a new drug to treat advanced primary head and neck cancer. Head and neck cancer represents about 6% of new cancer patients.
The primary endpoint of the Phase 3 study is a 10% improvement in overall survival for patients treated with Multikine treatment regimen plus Standard of Care (SOC) versus patients treated with Standard of Care alone. Per the study’s protocol, this will be determined after a total of 298 events (patient deaths) have occurred in the two main comparator arms of the study and have been recorded in the study database.
Arbitration suit filed by us against our former CRO
In October 2013 CEL-SCI filed an arbitration seeking at least $50 million from the CRO that originally ran the Phase 3 head and neck cancer study. CEL-SCI's arbitration claim alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud. The last witness in the arbitration hearing testified in November 2017. No further witnesses or testimony are expected. With that final witness, the testimony phase of the arbitration was concluded. All that remains at the trial level are closing statements and post-trial submissions. We look forward to concluding the arbitration soon and receiving the arbitrator’s final decision.
Rheumatoid Arthritis Vaccine, Offering New Treatment Paradigm, Receives $1.5 M NIH Grant
CEL-SCI received a $1.5 million grant from the U.S. National Institutes of Health (NIH) to develop our potential rheumatoid arthritis vaccine, CEL-4000. CEL-4000 is the first product candidate based on our LEAPS (Ligand Epitope Antigen Presentation System) vaccine platform. The grant provides funding to advance our rheumatoid arthritis vaccine towards filing an Investigational New Drug (IND) application. The grant provides funding for developing GMP manufacturing, and performing IND enabling studies, and additional mechanism of action studies.
Pre-clinical studies showed that CEL-4000 prevented the development and lessened the severity of arthritis in animal models resembling the human disease. Therefore we believe it has the potential for use as a therapeutic vaccine to treat rheumatoid arthritis in humans. CEL-4000 data were published in an article in the July 2017 issue of the scientific journal Vaccine, as well as presented at several scientific conferences in 2017 including:
- Madridge's International Conference on Vaccines in Baltimore, Maryland
- 17th Annual World Vaccine Congress in Washington D.C.
- 2017 Annual Meeting of the American Association of Immunologists in Washington, D.C.
In addition to rheumatoid arthritis, our patented LEAPS technology-based vaccine platform may be used as therapeutic treatments for a variety of different types of autoimmune conditions. LEAPS vaccines act early on the immune response path and inhibit the production of disease-promoting inflammatory cytokines, making these treatment vaccines unique and potentially effective means of preventing and treating autoimmune diseases.
As we begin 2018, we have completed full enrollment in the world’s largest clinical trial in head and neck cancer. As we monitor enrolled patients, we expect that a positive outcome in the trial would enable us to apply for regulatory approval in head and neck cancer in dozens of global markets. Our rheumatoid arthritis vaccine studies are currently being funded by an NIH grant. We await the final decision in the arbitration suit we filed against our former CRO in 2013.
We look forward to communicating our progress to our shareholders throughout 2018. I wish you all a healthy, happy and prosperous 2018.
Sincerely,
Geert Kersten
Chief Executive Officer
About CEL-SCI Corporation
CEL-SCI is a Phase 3 cancer immunotherapy company. 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, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine BEFORE they have received 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.
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.
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.
