VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American:CVM) today issued a letter to its shareholders.
| Dear Fellow Shareholders, |
| We have won the arbitration against the clinical research organization (CRO) inVentiv that ran our Phase 3 head and neck cancer study from 2011-2013. We also raised $12 million in new equity capital this year to strengthen our financial position. Our singular goal is to get to the final data readout of the Phase 3 trial to establish the utility of our investigational immunotherapy Multikine. |
| It has now been confirmed by the arbitration that inVentiv was the cause of the multi-year delay in our Phase 3 clinical trial in head and neck cancer. This delay made our investigational drug Multikine (Leukocyte Interleukin, Injection)* look as if it had little appeal to the medical community. We are delighted that the truth has finally been revealed. |
| The arbitrator’s decision will benefit CEL-SCI and you as a shareholder for the following reasons: |
| 1) | The arbitrator’s decision has vindicated us and made it clear that the CRO, not our drug, was the cause of the enrollment problem. | ||||
| 2) | Many funds and analysts did not like the legal risk of this arbitration as it dragged on for 4 ½ years and were reluctant to invest in the company while it was ongoing. Now that the arbitration is resolved in our favor, this should no longer be an impediment to investors and should result in renewed investment interest in CEL-SCI. |
| By September 2016, the new CROs were able to fully enroll our Phase 3 study with 928 patients. A fully enrolled pivotal Phase 3 cancer study, such as ours, where the only thing left to do is to follow the patients for final data readout, is typically worth multiples more than CEL-SCI’s current valuation. In fact, that low valuation is why members of management have continued to purchase more shares. |
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To be even more specific, CEL-SCI is a cancer immunotherapy company that has a market cap of about $20 million. In the past 18 months, several successful Phase 3 cancer immunotherapy companies were sold for $7 billion to almost $12 billion. They had positive survival data from their pivotal studies, but had not yet received FDA approval. Recently, one cancer immunotherapy company with not yet completed Phase 3 studies was sold for about $1.6 billion. |
| Should the CEL-SCI Phase 3 study be successful, the potential market for our drug will be substantially larger than the markets of the multi-billion dollar companies mentioned above. If we receive FDA approval, one could expect that we should become part of the standard of care (SOC) since the study endpoint of “improvement in overall survival” is the gold standard for cancer drug approval. In addition, the results coming from the largest head and neck cancer Phase 3 study ever conducted should support such change in the SOC. Multikine would then become the recommended very first treatment to be administered following diagnosis of cancer and before SOC, for a cancer that affects about 6% of all cancer patients. |
| There is currently only one standard of care (surgery followed by radiotherapy or combined radiochemotherapy) in advanced primary head and neck cancer prescribed by NCCN guidelines, and that treatment is the comparator arm of our Phase 3 study. The main treatment arm in the Phase 3 study is the Multikine treatment regimen plus the standard of care treatment. |
| No one has ever questioned the size of the market or the need for our drug. What dragged our valuation down was the multi-year delay in our Phase 3 clinical trial now known to have been caused by inVentiv, our former CRO. Now that the study is fully enrolled and the arbitration is behind us, we have a clear road to final data readout. |
| The endpoint of our study is a 10% increase in overall survival in the Multikine regimen treated group vs. Standard of Care (SOC). The study is event driven and the endpoint can only be determined when a total of 298 deaths have occurred. While no one can predict exactly when patients will die, we expect, based on an assessment of when patients were enrolled in our study and the expected time to death from diagnosis for the patient population treated with SOC reported in the literature, that a data readout may potentially occur in early 2019. |
| In the final Multikine Phase 2 open label “Proof of Concept” study the same three week Multikine treatment regimen prior to SOC was used as is being used in the Phase 3 study. The effects of a 3 week Multikine treatment regimen on the tumors that were removed at surgery (per SOC) following the Multikine treatment regimen was examined and evaluated by pathology. The findings were published in the Journal of Clinical Oncology and presented at ASCO. The pathologists found that about 10% of patients had no tumor cells remaining after a three week Multikine treatment, and the remaining patients had only about 50% of their tumor cells remaining. In a survival follow-up study of patients from the same Phase 2 study, it was determined that there was a 33% overall survival benefit compared to results obtained in 55 clinical trials reported in the scientific literature between 1987 and 2007 in the same patient population (Advanced primary Squamous Cell Carcinoma of the Head and Neck). The Phase 3 study is designed to prove a 10% overall survival benefit in a prospectively controlled study in a statistically significant manner. |
| The results of the Phase 3 study, if positive, will form the basis of our regulatory submissions for marketing applications worldwide to commercially market and distribute Multikine. FDA has not approved a new drug for advanced primary squamous cell carcinoma (cancer) of the head and neck in about 60 years, a clear unmet medical need. FDA also granted Multikine orphan drug status in this indication. |
| Our idea and aim is to help cancer patients by boosting their immune system BEFORE the ravages of surgery, radiation and chemotherapy. We believe that boosting a cancer patient's immune system while it is still intact, before surgery and/or radiation/chemotherapy, should provide the greatest possible impact on survival. Our Phase 3 study is meant to prove this. This is a logical concept and one that made sense to 24 regulatory agencies, including the FDA, when we applied to them to conduct this global Phase 3 study. This idea is now also starting to gain traction among oncologists. If we are successful in head and neck cancer, we hope to expand this concept to other cancers. |
| Investors, new and old, can now focus on the achievements that establish the true value of our company: 1) a fully enrolled Phase 3 clinical trial awaiting data readout and 2) a very promising rheumatoid arthritis treatment vaccine candidate, based on our LEAPS technology, funded by a large U.S. government grant. |
| Moving forward to a promising future, we plan to meet with and provide an update to interested investors, many of whom will be looking at CEL-SCI for the first time. |
| 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.
