Vienna, VA, January 3, 2018 -- 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.
