The following letter is being released by CEL-SCI Corporation (NYSE AMEX: CVM) to its shareholders:
Dear Fellow Shareholders:
At the end of last year we were excited to report that we started our pivotal Phase III trial for Multikine® in advanced primary head and neck cancer. This study is designed to demonstrate that our novel approach to the treatment of cancer is efficacious. If it is, as we believe the study will show, we will be able to provide enormous help and benefit to patients and their families while creating a very successful company. We should be able to significantly reduce the number of patients dying from head and neck cancer, and, in the future, maybe other types of cancers as well. We have designed this Phase III study very conservatively and with good results we should be able to assemble a data package so enticing that approval for marketing should be rapid.
Our goal has long been to create a new way of treating cancer. We wanted this new cancer therapy to be 1.) a non-toxic therapy which works with the body's immune system, 2.) useful against many different tumor types and 3.) cost effective. We designed this new therapy to make the first cancer treatment more successful because we recognized that it is the recurrence of cancer following the first treatment that often leads to the patient's death, and we reasoned that if recurrence of patients' cancers can be prevented there should be a substantial increase in survival. We believe that we have been successful in creating this new way of treating cancer with Multikine, and we have finally started the Phase III trial designed to develop the definitive proof of its efficacy required to receive marketing approval.
During the past 20 plus years our Company endured many challenges. Management funded the company when needed and dedicated employees worked without pay checks or with reduced paychecks. Then there were the games of greed. At the height of the internet bubble some directors tried to turn us into an internet company. During the last financial crisis hedge funds tried to take the company over, and more …. We believe that the results of the Phase III study will ultimately dictate our success, and we further believe that, given the huge amount of value our new cancer therapy would create, the games of greed will continue during the Phase III study. We are already seeing lies being spread on the internet about our study and our Company. People claim to know that the study was halted, that production of Multikine was halted, that patients were having problems, all falsehoods designed to influence others. We are dedicated to proving that Multikine works and that is our answer to those lies.
Our Phase III study was carefully designed to produce a complete set of data which will convince the FDA and other regulators around the world, as well as the scientific community, that Multikine represents a quantum leap forward in the treatment of cancer. Key factors in this design include:
| 1) | Â | The primary endpoint for the study is a 10% increase in the overall survival of Multikine plus standard of care treated patients vs. patients receiving current standard of care only. Increased overall survival represents the "gold standard" for cancer drug approval. |
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| 2) | The indication for which we will seek approval, advanced primary head and neck cancer, is considered an "unmet medical need" and Multikine has received "orphan drug" designation from the FDA for this indication. Orphan drugs often are approved more rapidly and with a greater chance of success and, in general, regulatory agencies will move faster on unmet medical needs. | |
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| 3) | This landmark study will also be the largest head and neck cancer study in the world and will enroll patients from 9 countries in 3 continents. This gives the data a lot of weight and allows us to apply for marketing approval in many places in the world. | |
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| 4) | Very large histopathology and molecular marker studies will be conducted as part of the Phase III trial to further define the mechanism of action of Multikine. In addition, the US National Institutes of Health (NIH) will be conducting genetic testing on tumor samples to determine how Multikine works down to the genetic level. This testing has the potential to determine if there is a genetic marker that can possibly predict clinical success with Multikine in specific patients. |
The following considerations also favor rapid approval of Multikine if the Phase III trial is successful:
| 1) | Â | Multikine has been shown in all previous studies to be non-toxic. It was not toxic when administered on its own, and there was no increased toxicity from other cancer therapies given along with it. Based on this experience, and the fact that Multikine will be administered in the Phase III trial in the same dose, route and frequency of administration as in the "proof of concept" Phase II trial, toxicity should not be a problem. The current head and neck cancer therapies are so toxic that the addition of toxicity from another drug might cause significant concern. It does not appear that this will be an issue with Multikine. |
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| 2) | If Multikine reduces the number of cancer recurrences and thereby increases the survival of cancer patients, it will save the health care system billions of dollars typically spent on the treatment of very sick cancer patients. This too will become more important in the future and speaks in favor of Multikine. | |
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| 3) | We previously announced that we have built a manufacturing facility for Multikine production. This effort delayed the start of the Phase III study, but without this facility we might not be able to satisfactorily address the many manufacturing questions that would arise at the time of approval for commercial marketing if Multikine had been produced for our Phase III trial in a contract manufacturing facility. Our Multikine manufacturing facility and process, as well as our quality control systems, have been audited by a European Union Qualified Person and passed that inspection with "high marks". |
We believe that it is possible to have a non-toxic cancer therapy. We believe that our immune system is capable of defeating cancer, but it needs help when fighting the tumor because the tumor cunningly blocks the immune cells from killing tumor cells. We believe that Multikine is the key to helping the immune system overcome the tumor's defenses. With Multikine we aim to remove the tumor's defense mechanisms so that the immune system, not yet weakened by surgery, radiation and/or chemotherapy, can successfully fight the tumor. We are the first company in the world to test an immunotherapy drug in a Phase III clinical trial in not yet treated cancer patients, the optimal time. Our Phase II study suggested that Multikine could be effective and our Phase III study is designed to prove this in a manner that will give us marketing approval.
We have started the study in the US. Over the course of the next few months you should see us, and our partners Teva Pharmaceuticals and Orient Europharma, roll out the study in all nine countries. By running the study in nine countries, many of which have many more patients than does the US, we should have much faster study enrollment, and therefore a much faster study result, than would be possible if we enroll only in the US. Worldwide there are about 650,000 new cases of head and neck cancer every year.
All of the financial success will accrue to us, the shareholders, because we did not license the key marketing rights out to a major pharmaceutical company. We are working diligently to move the study forward and plan to keep you up-to-date along the way. We have not taken shortcuts before and we will certainly not do so now. We have never felt more excited about the Company's future. We thank you for your support.
Sincerely,
| Geert Kersten | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Maximilian de Clara |
| Chief Executive Officer | President |
When used in this report, the words "intends," "believes," "anticipated" 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, 2010. 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.
Contacts:
CEL-SCI Corporation
COMPANY CONTACT:
Gavin de Windt,
703-506-9460
