VIENNA, Va., Feb. 17 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI Corporation to its shareholders:
We are pleased to report to you that the past 12 months have put CEL-SCI in the best position ever. During this difficult time we were able to complete and validate the manufacturing facility for our cancer drug Multikine, a critical step before being able to manufacture Multikine for the Phase III clinical trial. We are developing a novel investigational treatment for H1N1 hospitalized patients and were able to take this investigational treatment into a clinical trial at Johns Hopkins University in record time. At the same time we also raised over $40 million in new capital and added a new marketing partner for Multikine in South Africa. Unlike the existing partners, Teva Pharmaceuticals and Orient Europharma, who will be participating in the Phase III study in Israel and parts of Asia, Byron Pharma will only be focused on marketing and will not participate in the Phase III trial. With the manufacturing facility completed and $36 million in the bank, we are now able to start our Phase III trial for Multikine in advanced primary head and neck cancer.
The pathology data showed clear clinical benefit to the Multikine-treated patients and suggested that overall patient survival should be improved with Multikine administration. The longer-term follow-up of the Multikine-treated patients showed that overall survival indeed was improved in these patients. To avoid any bias, the Multikine survival data in the Phase II trial was compared to the results of all peer reviewed published data available at that time (39 publications). As time progressed and more publications became available, we updated this comparison and included all of the more recently published peer-reviewed data from these publications (a total of 55 publications). Our findings of the impact of Multikine administration on the overall survival benefit for these patients still held true.
While we already showed a 33% improvement in overall survival in Phase II, we only need 10% in the Phase III study to meet our primary endpoint. We have added multiple years to the development process of Multikine in order to build a Multikine dedicated manufacturing facility near Baltimore. This was done at the advice of the regulatory agencies and as an additional step of risk mitigation since the use of a contract manufacturer adds a great deal of risk in maintaining quality control. We have taken every conceivable risk mitigation step to increase the probability of a favorable outcome for this breakthrough product.
We feel that we have created a great situation and opportunity for our shareholders with the development of Multikine as a first-line treatment for cancer. We have a great team and, for the first time, the funds to execute our plans.
Currently H1N1 does not appear to be a big problem in the US. However, it continues to infect and kill patients in other places around the world. Some people think that H1N1 is gone, like Avian Flu and SARS appear to be gone. H1N1 is different though. H1N1 has already infected different populations all over the world. It is the first flu virus that can infect humans throughout all four seasons. As a flu virus it undergoes rapid mutations. As such, similar to the normal seasonal flu, we are likely to see H1N1 reappear in a mutated form. Our greatest fear is that it might pick up pieces of genetic information from the more deadly Avian flu or the Spanish flu and become an easy to transmit life threatening virus. To address this possibility, CEL-SCI scientists have included in the LEAPS-H1N1 investigational treatment non-changing parts of the H1N1 virus, as well as non-changing parts of the Avian flu and Spanish flu viruses. We will continue with the development of this investigational treatment because we expect it to become increasingly important in the future.
While success is never a certainty, we believe that we have already overcome many obstacles. We have positioned CEL-SCI and its investors to benefit from an opportunity that few small biotechnology companies ever get. The ability to conduct a pivotal clinical study in an area which represents a large unmet medical need, where the company maintains a substantial upside! A chance to develop a non-toxic cancer therapy! As always, we thank you for your support.
Geert Kersten
Chief Executive Officer
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, 2009. 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.
CEL-SCI Corporation
