• 8/24/2005
  • Vienna, VA
  • press release
  • PRNewswire (prnewswire.com)

CEL-SCI CORPORATION announces that it has achieved one of its most significant milestones to date. The Canadian regulatory agency, the Biologics and Genetic Therapies Directorate, has concurred with the initiation of a global Phase III clinical trial in head and neck cancer patients using CEL-SCI’s immunotherapy drug Multikine(R), the Company’s lead product. The formal “no objection” letter from the BGTD to the Clinical Trial Application (CTA), which was submitted last month, enables CEL-SCI to initiate the Canadian arm of the Phase III Multikine trial.

About 500 patients will be enrolled worldwide in the Phase III trial. The protocol is designed to develop conclusive evidence of the efficacy of Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity (head and neck cancer). A successful outcome from this trial should enable CEL-SCI to apply for a Biologics License to market Multikine for the treatment of this patient population.

The trial will test the hypothesis that Multikine treatment administered prior to the current standard therapy for head and neck cancer patients (surgical resection of the tumor and involved lymph nodes followed by radiotherapy or radiotherapy and concurrent chemotherapy) will enhance the local/regional control of the disease, reduce the rate of disease progression and extend the time of progression free survival in patients with advanced oral squamous cell carcinoma.

Geert Kersten, Chief Executive Officer of CEL-SCI, said, “Multikine has an anti-tumor mechanism of action that is different from the current cancer therapies and may enhance the success of radiotherapy and chemotherapy. We believe that the addition of Multikine to the current standard therapy for advanced primary squamous cell carcinoma of the oral cavity should result in further clinical benefit to these patients, without additional toxicity.”

Head and neck cancer is an aggressive cancer that affects about 500,000 people per annum worldwide.

Background on Multikine:
Multikine is a patented immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for treatment of cancer.

Clinical trials in over 200 patients have been completed with Multikine with the following results:

1) It has been demonstrated to be safe and non-toxic.

2) It has been shown to render cancer cells much more susceptible to
radiation therapy (The Laryngoscope, December 2003, Vol.113 Issue 12).

3) A publication in the Journal of Clinical Oncology (Timar et al, JCO, 23(15): May 2005), revealed the following:

(i) Multikine induced anti-tumor immune responses through the combined activity of the different cytokines present in Multikine following local administration of Multikine for only three weeks.

(ii) The combination of the different cytokines caused the induction, recruitment into the tumor bed, and proliferation of anti-tumor T-cells and other anti-tumor inflammatory cells, leading to a
massive anti-tumor immune response.

(iii) Multikine induced a reversal of the CD4/CD8 ratio in the tumor infiltrating cells, leading to a marked increase of CD4 T-cells in the tumor, which resulted in the prolongation of the anti-tumor immune response and tumor cell destruction.

(iv) The anti-tumor immune-mediated processes continued long after the cessation of Multikine administration.

(v) A three-week Multikine treatment of patients with advanced primary oral squamous cell carcinoma resulted in an overall response rate of 42% prior to standard therapy, with 12% of the patients having a complete response.

(vi) A histopathology study showed that the tumor load in Multikine treated patients was reduced by nearly 50% as compared to tumors from control patients in the same pathology study.

(vii) The tumors of all of the patients in this Phase II trial who responded to Multikine treatment were devoid of the cell surface
marker for HLA Class II. This finding, if confirmed in this global Phase III clinical trial, may lead to the establishment of a marker for selecting the patient population best suited for treatment with Multikine.

CEL-SCI Corporation is developing new immune system based treatments for cancer and infectious diseases. The Company has operations in Vienna, Virginia and Baltimore, Maryland.