US-based CEL-SCI has obtained an approval from the Health Protection Administration, Ministry of Health, of the Croatian Republic to begin patient enrollment in Phase III clinical trial of its investigational cancer immunotherapy treatment, multikine (leukocyte interleukin, injection).
CEL-SCI anticipates enrolling approximately 40 patients in the Phase III trial at four clinical centers in Croatia.
Croatia is the ninth country into which CEL-SCI has expanded its global Phase III trial.
The company anticipates conducting the Phase III trial in approximately 100 clinical centers globally.
CEL-SCI plans to ramp up the patient enrollment in its Phase III clinical trial by adding a large number of clinical centers in the eight countries, where the company has already received approval to initiate the trial, and by adding new countries and centers across the globe.
These new centers are in addition to the Phase III clinical centers run by CEL-SCI's partners, including Teva, Israel and Orient Europharma, Taiwan.
CEL-SCI CEO Geert Kersten noted the company is truly seeing major progress in advancing its study since engaging the two new CROs Ergomed and Aptiv Solutions, following the 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," Kersten added.
In November, CEL-SCI has announced that an Independent Data Monitoring Committee has completed a second interim review of the safety data from its pivotal Phase III study of Multikine investigational new drug immunotherapy.
The committee concluded that the data from the randomized, controlled Phase III study 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 Phase III study has been designed to demonstrate a statistically significant, 10% improvement in overall survival of enrolled patients who are treated with Multikine plus standard of care (SOC), compared to 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.