VIENNA, Va.--(BUSINESS WIRE)--The following letter is being released by CEL-SCI Corporation (NYSE MKT: CVM) to its shareholders:
Dear Fellow Shareholders:
As you know, we are currently running the largest ever Phase III clinical trial in head and neck cancer, a disease with a clear unmet medical need, with our investigational Multikine* immunotherapy. The trial is currently being conducted in eight countries on three continents. It is designed so that if successfully completed the results will allow us to seek marketing approval in the key markets around the world. Our clinical study is the first trial in which immunotherapy is given before the standard of care (SOC) cancer therapies which consists of surgery, radiation and chemotherapy. Multikine is given prior to SOC because we believe that the stimulation of the immune system of a cancer patient after those cancer treatments is extremely difficult due to the known immuno-suppressive effects of surgery, radiation and chemotherapy. We are confident that our approach of early stimulation of the immune response will be proven to be correct.
This fall we took a big first step towards clearing a key hurdle in the Phase III trial. We were able to announce that our study’s Independent Data Monitoring Committee (IDMC), when reviewing the study data collected to date, advised that the study should be continued since the committee saw no safety signals which should end the study. We view this as a very positive event because safety and tolerability are key risks in all Phase III clinical trials. In October 2012 a Phase III study of a drug owned by Reata Pharmaceuticals and licensed to Abbott Labs for about $450 million was stopped due to safety problems. Several years ago Pfizer had to stop the Phase III study for its Lipitor successor at an estimated cost of $1 billion due to safety problems. In fact, a recent study estimated that up to 30% of Phase III trials fail on safety. So far our Phase III study results for the safety profile of this novel approach and investigational therapy regimen appear to track the results we obtained in our Phase II studies, and that is exactly what we wanted to see.
We are encouraged by the study’s IDMC findings, and as a result are now more aggressively expanding the study in the US and Western Europe. Our goal, now that the first IDMC interim safety review is behind us, is to further accelerate the patient recruitment by increasing the number of centers from the current 36 centers to, at least, the originally planned 50 centers. We are currently negotiating to bring on highly regarded US hospitals as well as European centers in multiple countries. We will keep you up-to-date on important developments occurring during the trial. We understand the desire of our shareholders to know as much as possible about our study’s progress, but ask you to understand that a lot of information cannot be shared publicly since it might bias the study results, which ultimately could lead to major problems in the Phase III trial and impede the possible approval of Multikine for commercial use by regulatory agencies.
Other company activities: Our L.E.A.P.S. collaborative study with the National Institutes for Allergy and Infectious Diseases (NIAID) on pandemic flu is also progressing well. The testing conducted by NIAID with our L.E.A.P.S. compounds has shown significant promise in animal models of the disease and has been submitted for publication. We believe that the data will potentially be very relevant when the next strain of drug resistant flu makes an appearance.
We are well into the final, and pivotal, study with Multikine designed to definitively prove that it will increase overall survival in a disease with a clear unmet medical need, where the last drug approval was about 50 years ago and where no other drug is in late stage development. Our goal is to replicate the promising results from our Phase II studies and so far that is what we are seeing. From here on we have a clear path to potentially enormous success. Few people ever get the chance to be part of something as significant as this. We thank you for your support during this Phase III clinical trial.
Sincerely,
| 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.