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:
- Our Phase III study for Multikine started in one US cancer center in the final days of 2010. During 2011 we initiated 36 additional hospitals in 8 countries on three continents. That is a very fast pace for adding clinical sites to an international study.
- Patients were enrolled in the study on all three continents (North America, Europe and Asia).
- Our partners Teva Pharmaceuticals Industries (Israel) and Orient Europharma (Taiwan) enrolled patients in their respective territories.
- We produced multiple lots of Multikine in our manufacturing facility near Baltimore, Maryland, USA and provided drug in sufficient amounts at all clinical sites.
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|