VIENNA, Va., May 23 /PRNewswire-FirstCall/ -- CEL-SCI CORPORATION announces the presentation of long-term survival data from its Phase II clinical trial in patients with head & neck cancer (oral squamous cell carcinoma -- OSCC) treated with its anti-cancer drug Multikine(R). The addition of Multikine as first-line treatment prior to the standard of care treatment resulted in a 33-40% improvement in the median survival at 3 1/2 years post-surgery, when compared to the results of 39 OSCC clinical trials published in the scientific literature between 1987 and 2004. The data were presented at the “Vaccine Discovery and Commercialization” conference in Philadelphia, PA.
The long-term survival data were collected by the treating physicians in a follow-up study of 22 patients with advanced untreated primary tumors, who were enrolled in the Multikine Phase II clinical trial. The Multikine treatment regimen was administered to these patients prior to the standard of care treatment (i.e., surgery + radiation or surgery + chemo-radiation). Informed consent was obtained from all patients in the clinical trial and from 19 patients for the long-term follow-up study. Investigational Review Board / Ethics Committee approval was provided before the initiation of the clinical trial and again for the data collection in the follow-up study. The follow-up study questionnaire assessed the overall survival and the local regional control of the Multikine treated patients in this Phase II trial.
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.
The median overall survival (calculated by including death from any cause of patients in the trial, even deaths not related to the disease) of the 19 evaluable patients in the follow-up portion of this clinical trial was 63% at a median follow-up of 40 months post-surgery. The results of the published scientific literature (39 OSCC clinical trials published between 1987 and 2004) document that survival at 3 1/2 years is approximately 47% following standard of care treatment. The addition of Multikine to the standard of care treatment resulted in a 33% increase in overall survival over the results published in the literature.
The median survival of patients in this clinical trial was 67% at a median follow-up of 42 months post-surgery, excluding the one patient with immediate post-operative death. The same 39 scientific publications indicate that survival at 3 1/2 years is approximately 47% following standard of care treatment. The addition of Multikine to the standard of care treatment resulted in an increase in survival of 40% over the results published in the literature.
Multikine first-line treatment also resulted in a 2-year local regional control (LRC) rate of 79%, as compared to the median 2-year LRC of 73% reported in the same 39 scientific publications. Multikine treatment resulted in an improvement over the published local regional control rate. It is clinically recognized that recurrence of disease in head & 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. No SAEs related to Multikine have been reported in other trials conducted with Multikine either.
The data from CEL-SCI’s Multikine Phase II clinical trial are thought to be directly applicable to CEL-SCI’s planned global Phase III clinical trial, as the Multikine treatment regimen planned in the Phase III trial is identical to that of the Multikine treatment in the trial reported here. Furthermore, the planned endpoints of the Phase III trial are local regional control, disease-free survival and overall survival, all of which have shown improvement compared to historical controls, following Multikine first-line treatment over the current available treatments for these patients.
Head & neck cancer is an aggressive cancer that affects 500,000 people per annum worldwide, and approximately 2/3 of patients present with advanced disease.
Multikine is a patented immunotherapeutic agent consisting of a mixture of naturally-occurring human cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for the treatment of cancer.
CEL-SCI Corporation, with operations in Vienna, VA and Baltimore, MD is developing new immune system based treatments for cancer and infectious diseases. CEL-SCI’s other products are currently in the pre-clinical stage of development. Pre-clinical animal studies have received U.S. government support. The results of these studies indicate these products may offer protection against a number of diseases. The agents are being tested, among others, against diseases associated with bio-defense and avian (bird) flu.
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, 2005. 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, orInvestor Relations: Mike Lucci of Lucci Financial Group, LLC,+1-248-723-3330, for CEL-SCI Corporation
Web site: http://www.cel-sci.com/
