Exclusive Interview: Cel-Sci CEO (CVM)

Benzinga brings you an exclusive CEO interview today with Geert Kersten of Cel-Sci

. Happy New Years! On December 29,

about its phase III clinical trial in head and neck cancer. This was landmark big news for the company, with shares hitting a high over 30% after the news. (Shares have now retraced most of their gains.) In its announcement , Cel-Sci said it expects to enroll approximately 880 patients to test its leading therapy Multikine as an initial treatment for newly diagnosed head and neck cancer patients. The company says this will be the largest head and neck cancer study ever conducted. Having 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. Investors are interested in the eventual commercial potential of Cel-Sci's treatment product. Investors know that their company has already spent over $25 million on a customized manufacturing facility for this cancer treatment product, and they are anxious to see it begin production. On the phone today with Benzinga, Cel-Sci CEO Geert Kersten mentioned that he is extremely excited about his company's launch into phase III and sees definite potential for commercialization of their treatment product pending positive data from the study. On a personal level, Kersten has been anticipating this study for decades. He fought opposition and constant discouragement from friends, family, and peers, who said "he's wasting his time." Kersten never thought that getting to this point would be as difficult as it has been, and he has fought for the survival of his company on multiple occasions to reach the third phase of trial. Nevertheless, the progress will continue to take time to reach FDA approval. Kersten reminded Benzinga that Cel-Sci is preparing for head and neck cancer treatment as a "new, unmet medical need." This open-label study will require 15-18 months to enroll patients alone, and the study might require testing all the way until patient mortality. This is obviously quite a long timeframe. However, Kersten emphasized that Cel-Sci is taking no shortcuts and plans to trailblaze this "largest worldwide head and neck cancer study ever." Kersten noted that the study will occur over time in nine countries, including the U.S. If the treatment is eventually approved, it will be the first non-toxic cancer treatment of its kind (as opposed to toxic methods like chemotherapy). Looking forward, the company noted that it is prepared for the full responsibilities of this large research study. Benzinga asked about financing, and Kersten noted that equity financing is likely in the coming years, which is "to be expected" for a phase III study. Moreover, the company reiterated that it has been meeting with the FDA and had agreed upon a conservative approach and protocols for this potentially landmark study.