CEL-SCI initiates Multikine Phase III trail for head and neck cancer

CEL-SCI Corporation announced today that it has commenced its Phase III clinical trial for Multikine^®, the Company's flagship immunotherapy. CEL-SCI has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study. The goal of this study is to establish Multikine as a first-line standard of care therapy in treating newly diagnosed head and neck cancer patients. The trial is believed to be the largest head and neck cancer study ever conducted and is called "IT-MATTERS", an acronym for: Immunotherapy Multikine Anti Tumor Treatments.

“We are very excited to begin this pivotal study”

The Company expects to enroll approximately 880 patients at about 48 clinical centers in 9 countries (USA, Canada, Hungary, Poland, Ukraine, Russia, India, Israel and Taiwan) in the IT-MATTERS trial. CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the Phase III study in Israel and Taiwan respectively. All study sites, including those in Israel and Taiwan, are under the control of CEL-SCI's global Clinical Research Organization. The trial is open label, randomized, controlled and patients are prospectively stratified.

"We are very excited to begin this pivotal study," said Geert Kersten, Chief Executive Officer of CEL-SCI. "Our team believes that all of the necessary measures have been taken to maximize the probability of a successful outcome for the study."

Additional details on the trial include:

1. CEL SCI has selected increased overall survival, the most stringent endpoint that can be chosen for a cancer clinical trial, as the primary endpoint. A 10% absolute increase in overall survival in the Multikine arm of the study over what can be achieved with current standard of care therapy (SOC) alone is currently considered a clinically meaningful result for this patient population by the medical community. Based on the results of the Company's proof of concept Phase II study, which demonstrated that Multikine has the potential to increase overall survival by 33%, CEL SCI believes it can demonstrate at least a 10% absolute increase in overall survival of subjects treated with Multikine.
2. In addition to assessing the primary endpoint of overall survival, an extensive microscopic examination of the pathology of the head and neck cancers treated with Multikine will be undertaken. These pathology studies will allow the Company to observe the immune response(s) to Multikine at the cellular level.
3. In a separate "in vitro" laboratory study being conducted in collaboration with experts at the National Institutes of Health (NIH) on biopsy specimens collected from consenting study subjects, genetic tests will be performed and data will be collected and analyzed that should shed further light on the mechanism of action of Multikine down to the genetic and molecular level.
4. A dedicated Multikine manufacturing facility has been constructed to better control the manufacture of this complex biologic therapy. This facility even includes a fill room that allows CEL-SCI to fill Multikine at 4 degrees Centigrade, a unique advantage when filling any biologic product.

Eyal Talor, Chief Scientific Officer of CEL-SCI said: "We believe that by investing so much time, financial resources and effort ahead of this study, we have increased the likelihood that the data derived from the study will be of the type and quality required by regulators worldwide to support the applications for marketing approval. We hope to have all 48 clinical sites enrolling patients within a few months, a very fast timeline considering that this study is run in 9 countries on 3 continents."

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 Radiochemotherapy) used for treatment naive 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. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted.

Recently, the Company announced that, following an audit of its Multikine manufacturing plant and laboratories by a European Union Qualified Person (QP), the CEL-SCI facilities were found to be in a high level of compliance with the Good Manufacturing Practices (GMP) Directives of the International Conference on Harmonization (ICH). This determination clears the way for CEL-SCI to export Multikine to the European Union (EU) for use in the IT-MATTERS trial.

Phase II clinical trials of Multikine demonstrated 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 the "proof of concept" Phase II trial 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.