VIENNA, Va.--(BUSINESS WIRE)--
The following letter is being released by CEL-SCI Corporation (NYSE MKT: CVM) to its shareholders:
Dear Fellow Shareholders:
Over the past several months there have been a great number of positive changes in the underlying business of CEL-SCI. These changes have transformed the company from one focused on developing its lead investigational drug, Multikine* (Leukocyte Interleukin, Inj.), for the treatment of head and neck cancer, which represents 6% of the world’s cancer cases, into one that is developing Multikine as an immunotherapy technology platform with the capability to treat multiple diseases, even certain virally induced conditions. The expanded work is being undertaken with a whole new group of partners, including the U.S. Navy, and it provides us tremendous potential to explore and capitalize on multiple opportunities for different potential uses for Multikine. It also allows us to unlock significant value in our company. My own stock purchases in the open market are evidence of my faith in this broader strategy.
We are conducting what we believe to be the largest Phase III study ever conducted for the treatment of head and neck cancer. As you may know, the Clinical Research Organization (CRO) InVentiv, who we hired to run this study, did not enroll patients at the agreed to pace and, for that reason and others, CEL-SCI terminated InVentiv in or about April 2013 and replaced them with two other clinical research organizations, Aptiv Solutions, Inc. and Ergomed Clinical Research Ltd. In October 2013, CEL-SCI filed an arbitration claim against InVentiv under the Commercial Rules of the American Arbitration Association alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud seeking at least $50 million in damages. Arbitration proceedings are not public, so we cannot share further details at this time.
Our Phase III study has had a significant increase. The speed and efficiency with which Ergomed and Aptiv have performed since April in lining up new clinical centers and investigators, and gaining regulatory approvals, are a testament to the strength of our science, study design, and scientific interest in our treatment. So far in the last 6 weeks we have had patients from 7 countries screened for the study. We have even screened patients in the latest 2 countries that we added to the study only recently, Croatia, and Bosnia Herzegovina. All of these developments represent substantial progress, which we hope will continue under the new CROs. As the additional clinical centers which have been added and those that will be added become more familiar with the Phase III treatment protocol requirements, we expect that patients will be enrolled in our study at a progressively and significantly increased rate.
Successful Investigator Meetings for the 56 European hospitals and the 14 North American hospitals participating in the study were held this fall. We have also been pleased to be able to report to you and our clinical investigators that we recently received our second favorable interim review from the Independent Data Monitoring Committee (IDMC) for this trial. The IDMC confirmed that the study data raised no safety concerns, and recommended that the Phase III study continue unmodified. As you might imagine, this was very important and encouraging information to be able to share with the investigators.
We have a Phase III study co-development agreement with Ergomed, whereby they will cover up to $10 million of the cost of our ongoing Phase III clinical trial. This is important since Ergomed is responsible for most of the patient enrollment, and the rate of patient enrollment sets the pace of the study. We believe that this co-development model aligns Ergomed’s interests with ours, and should lead to faster enrollment. Ergomed will be repaid from sales of Multikine.
In addition to the Phase III head and neck cancer study, we are also utilizing our Multikine investigational immunotherapy platform technology to explore two other diseases: cervical dysplasia in HIV/HPV co-infected patients, and anal warts in HIV/HPV co-infected patients. We chose to investigate Multikine’s potential to treat HPV (human papillomavirus) associated diseases in HIV co-infected individuals based on the promising results obtained with Multikine in a previous study in HIV/HPV co-infected women with cervical dysplasia and because these diseases both have a critical unmet medical need. If we are successful in treating these diseases with Multikine this success could translate into significant market opportunities for Multikine.
HPV is the number 1 sexually transmitted disease in the world. HPV infection is a particularly significant health problem in the HIV infected population as individuals are now living longer as a result of greatly improved HIV medications. People living with HIV and others with compromised immunity are at significantly greater risk for HPV-related complications, and the current treatments for them are sub-standard. Persistent HPV infection and the changes it brings about in the surrounding tissue can also make it a precursor to cervical, anal and head and neck cancer.
These new studies are being conducted with partners. We recently entered into a co-development agreement with Ergomed to conduct a Phase II trial to treat cervical dysplasia in HIV/HPV infected patients, and we are currently working with the U.S. Navy on a Phase I trial for the treatment of anal warts in HIV/HPV infected patients. Ergomed has signed a co-development agreement to work on the anal-warts indication as well, in support of the Navy work if and when needed. Our three co-development agreements with Ergomed are worth up to $16 million.
The new collaboration with the U.S. Navy deserves special discussion. In October 2013 we announced the signing of a Cooperative Research and Development Agreement (CRADA) with the U.S. Navy for the treatment of anal warts in HIV/HPV co-infected men and women. CEL-SCI will supply Multikine for the trial, and the trial will be conducted at the San Diego Naval Medical Center. We expect this clinical study to start early next year. The disease is much worse than most people would imagine and one must see pictures to properly understand it.
We believe that the disease indication being pursued by the U.S. Navy may represent a relatively quick way to generate the clinical data required to submit an application for marketing approval for Multikine. The nature of the anal warts disease in HIV infected people allows for a much shorter follow-up period of patients to determine efficacy than is required in our current head and neck cancer Phase III study and the studies required to support a marketing application can be completed more rapidly. We are very hopeful, based on the results seen with Multikine in an earlier study of HIV infected women with cervical dysplasia, that we will be able to show good results in the studies with the U.S. Navy and Ergomed. Confirming in any of these studies that Multikine clears HPV in HIV infected people, as it did in the earlier study, will also likely bring more interest to Multikine in the head and neck cancer Phase III study since HPV is now known also to be involved in head and neck cancer. In fact, in the US we are seeing a rapid increase in head and neck cancer in younger people, due to HPV infection. Showing activity against HPV while activating the immune response to fight the cancer may have a very significant impact on the value of Multikine as a potential future immunotherapy platform.
In short, we now have a much improved balance sheet having just raised $17.8 million, a resurgent Phase III head and neck cancer trial, new partners including the U.S. Navy and Ergomed, and are pursuing two additional disease indications both of which potentially have fast paths to market.
Our team has pursued a vision of bringing to market a better and less toxic way of treating cancer and through this journey we have discovered that Multikine may have benefits to people suffering from diseases other than just head and neck cancer. We thank you for your support in helping us get new treatments to market for critical unmet medical needs.
Chief Executive Officer
* 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 its 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 release, 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, 2012. 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.
- Health Care Industry
- head and neck cancer
Gavin de Windt, 703-506-9460