VIENNA, Va., May 21 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION announced today that its cancer drug Multikine(R) was shown to significantly increase long term overall survival in a Phase II study of head and neck cancer patients. The data were presented on May 20, 2007 at the First International Congress of the International Association of Oral Oncology in Amsterdam, the Netherlands, by Dr. Eyal Talor, Senior VP of Research and Manufacturing at CEL-SCI Corporation.
Dr. Talor’s presentation focused on the results obtained in CEL-SCI’s final Phase II clinical trial of Multikine that was conducted in patients with head and neck cancer (oral squamous cell carcinoma -- OSCC). This final Phase II clinical trial was designed to assess thoroughly the positive safety and efficacy observations made in patients treated with Multikine in CEL-SCI’s early Phase II trials. In the trial Multikine was given prior to standard care to recently diagnosed and not yet treated cancer patients.
The addition of Multikine to the first treatment (standard of care) of these patients resulted in a 33% improvement in the median overall survival at 3-1/2 years post-surgery, when compared to the survival results reported in 55 OSCC clinical trials published in the scientific literature between 1987 and 2007.
Multikine first-line treatment also resulted in an improvement of the 2- year local regional over the published local regional control rate. It is clinically recognized that recurrence of disease in head and neck cancer is associated with a very poor prognosis. Multikine treatment did not result in any severe adverse events (SAE) in this Phase II clinical trial and no SAEs related to Multikine have been reported in other trials conducted with Multikine either.
CEL-SCI received clearance from the United States Food and Drug Administration (FDA) to proceed to a Phase III clinical trial with Multikine earlier this year. The same treatment regimen that was used in CEL-SCI’s final Phase II trial will be used in the upcoming Phase III trial that CEL-SCI will undertake since the results obtained in the final Phase II trial are thought to be indicative of the results one might expect in any Phase III trial of Multikine. The Phase III trial is designed to demonstrate a 10% increase in overall survival of patients treated with adjuvant Multikine therapy versus those treated only with the current standard of care.
Dr. Talor said, “Having shown a 33% increase in overall survival with no safety concerns in the final Phase II study, we are very hopeful that we will successfully reach the 10% increase in overall survival that is the primary endpoint of our Phase III trial. To further enhance the probability of meeting our primary endpoint, we are over-enrolling the study.”
Documented data were available for 19 of the 22 patients in the follow-up portion of this clinical trial. Of the three patients who could not be evaluated in the follow-up study, one patient was known to be alive, but failed to give informed consent, and the other two were lost to follow-up. One patient died the day after definitive surgery, unrelated to Multikine therapy.
Head & neck cancer is an aggressive cancer that affects over 500,000 - 600,000 people per annum worldwide.
CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has received the go-ahead from the U.S. FDA and the Canadian Regulators to conduct a Phase III clinical trial in advanced primary head and neck cancer patients with its lead product Multikine. CEL-SCI’s other products, which are currently in pre-clinical stage and have been funded with U.S. government support, have shown protection against a number of diseases in animal tests and are currently being tested against diseases associated with bio-defense and avian flu. The Company has operations in Vienna, Virginia and 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, 2006. 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
CONTACT: Gavin de Windt of CEL-SCI Corporation, +1-703-506-9460
Web site: http://www.cel-sci.com//
