The following letter was provided to shareholders by CEL-SCI Corporation (NYSE MKT: CVM) for today’s annual shareholder meeting:
Dear Fellow Shareholders:
Last year, 2011, was an exciting year for us because we were finally able to start our Phase III clinical trial for our investigational cancer drug Multikine® (Leukocyte Interleukin, Injection)*. This trial is the largest head and neck cancer study ever conducted in the world and is designed to hopefully give us approval to market Multikine throughout the world.
This trial, which is designed to prove to the most rigorous standards that Multikine works, was launched in dozens of hospitals located in eight countries on three continents. All of us at CEL-SCI are very proud of this major accomplishment. If we are successful in proving that the addition of Multikine to the current cancer therapies increases the patients’ overall survival, we would then expect to submit the Multikine drug dossier to regulatory agencies around the world for approval.
It has been a long road to this point, but that appears to be the norm for a “first in a new class” drug such as Multikine. Our vision for Multikine has always been that, by activating the immune response against the cancer, it could be a useful addition to the current treatment options used by cancer patients and doctors – and that it should add little to no toxicity to the existing treatments being used. With this vision in mind we selected head and neck cancer, a hard to treat and devastating disease, as a first target for Multikine. Head and neck cancer represents a clear unmet medical need, and there is currently one standard of care for its treatment worldwide. By adding Multikine to the current standard of care we hope to improve the overall survival currently achievable in these patients. As only little progress has been achieved in these patients in the past 50 years, this would be seen as a major achievement.
We carefully planned for, designed, and now are executing our Phase III clinical trial to the highest standard because we recognize that this is what it takes to succeed. We built a fully validated manufacturing facility near Baltimore, Maryland, USA, to ensure that the Multikine used in our Phase III trial would be consistent from lot to lot. Our study was intentionally designed to be very large and international in scope to improve our chances that the study results would be sufficiently robust so that it would not be required by the regulatory authorities that we conduct multiple studies to achieve approval of Multikine for commercial distribution. The international scope of the study will also increase rate of enrollment in the study so the study may be completed more rapidly, and allow us to submit applications for approval in multiple countries around the world. It is our strong belief that this study will prove that Multikine treatment will increase the overall survival of head and neck cancer patients.
The following is a brief summary of the key operational successes in 2011:
I am constantly being asked how the study is going. As you may know, I am not allowed to discuss the study results at this early stage. However, that being said, our confidence may be best expressed by the decision made to expand the trial into four extra territories at additional expense and effort, with the help of our partner Teva in certain areas. We are doing so because we want to complete the study to prove Multikine’s effectiveness as quickly as possible and hopefully receive marketing approval from the regulators.
If we are able to replicate the promising results seen in our earlier studies and prove that Multikine increases the overall survival of cancer patients by 10% (the study’s primary end point) or more, how much value will this create for our shareholders? No one knows exactly, but it should be significant. By way of example, in 2011 we witnessed the largest acquisition ever of a company with products still in clinical development, not yet on the market. Gilead Sciences bought Pharmasset (Hepatitis C) for about $11 billion in cash. The take home message from this acquisition is clear. Established pharmaceutical companies are willing to pay very large amounts of money for products that address both a large market and represent an unmet medical need. They prefer to wait until most of the risk has been taken off the table. Multikine addresses advanced primary (not yet treated) head and neck cancer, about 5-6% of the world’s cancer cases, clearly a large market. Advanced primary head and neck cancer also represents a clear unmet medical need.
The processes of manufacturing of biological substances and running clinical trials in cancer are extremely complex. We are able to do both because we have assembled a team of world experts who share our vision to help cancer patients. We thank you for your continued support and wish you a very happy, healthy and prosperous 2012.
|Geert Kersten||Maximilian de Clara|
|Chief Executive Officer||President|
* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our 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 (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.
When used in this report, 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 which 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 Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2011. 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.