Company Completes Key Step in Preparation for Pivotal Phase III Trial
VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) announced today that it has successfully produced and filled its first lot of Multikine® in preparation for the upcoming pivotal Phase III trial targeting advanced primary head and neck cancer.
The drug was filled in CEL-SCI’s state-of-the-art "Cold-Fill" manufacturing facility. The Company completed this test in order to ensure that it is able to produce significant quantities of Multikine to support the 880 patient clinical trial which is expected to commence prior to the end of the year. CEL-SCI's manufacturing facility, located outside of Baltimore, has been designed to fill biologics such as Multikine in true cold conditions (4 degrees Centigrade) which prevents/minimizes the loss of biological activity.
"Over the past few months, we have been highly focused on staffing and testing the facility in order to ensure that we have the equipment, resources and personnel to deliver Multikine to patients in the Phase III trial," said Geert Kersten, CEL-SCI's Chief Executive Officer. "We recognize that in a trial of this scale involving a biologic there are many precautions that we need to take, and we have made excellent progress in completing these tasks so we can begin the trial later this year. With a strong balance sheet, the new manufacturing facility, a global CRO in place and having Phase III partners Teva Pharmaceuticals and Orient Europharma, we are well positioned to take Multikine through this pivotal trial. We believe that Multikine represents a paradigm shift in the way cancer patients are treated."
In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to eliminate the tumors in 12% of the patients after only three weeks of treatment. Follow-up showed an improvement in the survival rate of those patients treated with Multikine of 33% at a median of three and a half years following surgery. Results of the trial also showed that the treatment regimen killed, on average, about half of the cancer cells before the start of standard therapy like surgery, radiation and chemotherapy. The U.S. Food and Drug Administration gave the go-ahead for a Phase III clinical trial and granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
CEL-SCI is also engaged in multiple other activities related to the start its Phase III clinical trial in 9 countries around the world. The trial is expected to be the largest head and neck cancer clinical study ever conducted, and is the first Phase III study in the world in which immunotherapy is given to patients first, prior to receiving any treatment for cancer, including surgery, radiation and/or chemotherapy. This should be the optimal time to stimulate an immune response against the tumor as the immune system has not yet been weakened by the conventional cancer therapies.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product is Multikine. In Phase II clinical trials Multikine was shown to be safe and well-tolerated, and to improve the patients' overall survival by 33 percent at a median of three and a half years following surgery. A pivotal Phase III clinical trial with Multikine in head and neck cancer is expected to start in the second half of 2010.
CEL-SCI is also developing an immunotherapy (LEAPS-H1N1-DC) to treat H1N1 hospitalized patients and a vaccine (CEL-2000) for Rheumatoid Arthritis using its LEAPS technology platform. The LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu as CEL-SCI scientists are very concerned about the creation of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. This investigational treatment is currently being tested in a clinical study at Johns Hopkins University. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
For more information, please visit www.cel-sci.com.
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.
Gavin de Windt, 703-506-9460
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