VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE AMEX: CVM) announced today that the Department of Health, Taiwan has issued an approval letter that allows enrollment of patients to begin in Taiwan in the Phase III clinical trial of Multikine®. The approval letter was issued by the Department of Health after manufacturing and stability data for the batches of Multikine that will be used in the trial in Taiwan were provided to them. The study in Taiwan is being run and paid for by CEL-SCI’s partner, Orient Europharma. Seven clinical centers will be enrolling patients. Enrollment of patients is expected to start within the next month in Taiwan.
CEL-SCI’s Phase III trial of Multikine will be conducted in approximately 48 clinical centers in nine countries. CEL-SCI's other partner Teva Pharmaceutical Industries is conducting and paying for the trial at three clinical centers in Israel. The Phase III trial started in the United States in late December 2010 and in India in late April 2011.
CEL-SCI’s Phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if Multikine administered prior to current standard of care (surgery plus radiotherapy or surgery plus concurrent chemo radiotherapy) in previously untreated subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival, versus the subjects treated with standard of care only. CEL-SCI’s 880 patient Phase III trial is expected to be the largest clinical study of head and neck cancer ever conducted. It is also the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. This is significant because conventional cancer therapy weakens the immune system and likely compromises the benefits of immunotherapy.
Phase II clinical trials of Multikine demonstrated that the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects’ tumors before the start of standard therapy. Follow-up studies of subjects enrolled in Phase II proof of concept study showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery. The U.S. Food and Drug Administration granted orphan drug status to Multikine in the neoadjuvant therapy of patients with squamous cell carcinoma of the head and neck.
About CEL-SCI Corporation
CEL-SCI Corporation is developing products that empower immune defenses. Its lead product, Multikine, is currently being tested in a global Phase III clinical trial that started in December 2010. 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 half years following surgery. Multikine is the Company’s flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.
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 H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
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.
Gavin de Windt, 703-506-9460
KEYWORDS: United States Asia Pacific North America Virginia Taiwan
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Oncology Pharmaceutical