This new country approval is the beginning of a big expansion of CEL-SCI?s Phase III clinical trial to about 20 countries.
CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has received approval from the Health Protection Administration, Ministry of Health, of the Croatian Republic to begin enrollment of subjects into the Phase III clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Croatia is the ninth country into which CEL-SCI has expanded its global Phase III trial. The trial is expected to be conducted in about 100 clinical centers worldwide. CEL-SCI expects to enroll approximately 40 patients in Croatia through four clinical centers.
CEL-SCI plans to accelerate enrolment in its Phase III clinical trial for Multikine by adding a large number of clinical centers in the eight countries where approval to start the trial was previously received and by adding new countries and centers around the world. These new centers are in addition to the Phase III clinical centers run by CEL-SCI’s partners (Teva, Israel and Orient Europharma, Taiwan).
“We are truly seeing major progress in advancing our study since engaging the two new CROs Ergomed and Aptiv Solutions, following our dismissal of the prior CRO that was managing the study, Inventiv, for lack of performance. Ergomed, which is responsible for about 95% of the patient enrollment in the trial, has invested $10 million of its own funds in the Phase III trial and, since then, has invested another $6 million in two other Multikine collaborations with CEL-SCI. Both CROs understand the potential of our science and share our vision, commitment, and diligence to bring this groundbreaking immunotherapy to market,” stated CEL-SCI CEO Geert Kersten.
On November 5, 2013 CEL-SCI announced that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine investigational new drug immunotherapy was completed by the Independent Data Monitoring Committee (IDMC). The Committee, which is comprised of world class leaders in head and neck cancer, concluded that the data raised no safety concerns, and recommended that the Phase III study continue unmodified.
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant, 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.
CEL-SCI's lead investigational therapy, Multikine, is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved by regulatory agencies (e.g. FDA) for use following completion of our clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body's natural ability to fight tumors.
On October 31, 2013 CEL-SCI announced that it had initiated an arbitration claim against inVentiv Clinical, LLC (f/k/a PharmaNet, LLC and PharmaNet GmbH (f/k/a PharmaNet AG)). CEL-SCI initially retained inVentiv Clinical to conduct the Phase III clinical trial of Multikine. CEL-SCI terminated inVentiv in or about April 2013 and replaced it with two clinical research organizations, Aptiv Solutions, Inc. and Ergomed Clinical Research Ltd. CEL-SCI’s arbitration claim is initiated under the Commercial Rules of the American Arbitration Association alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud, and seeks at least $50 million in damages.