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news.US-based CEL-SCI has received approval from the Philippines Regulatory Agency (PFDA) to begin patient enrollment in the Phase III trial of its investigational cancer immunotherapy Multikine (Leukocyte Interleukin, Injection) in the Philippines to treat head and neck cancer.
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The company said that three hospitals in the Philippines are expected to join the Phase II trial.
Philippines is the 19th country to approve the company’s Phase III trial, which is expected to expand into a total of 100 clinical centers in about 20 countries in addition to the US.
So far more than 350 patients with advanced primary, not yet treated, head and neck cancer have been enrolled in the trial.
The trial’s objective is to show a statistically significant improvement in the overall survival (OS) of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC), compared with patients who are treated with SOC only.
The company intends to complete patient enrollment in the open-label, randomized, controlled, global Phase III head and neck cancer trial by the end of 2015.
If approved for use following completion of the company’s clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer.
In October 2013, the company had signed a CRADA with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts.
The company has also entered into two new co-development agreements with Ergomed to further develop Multikine for cervical dysplasia/neoplasia in HIV/HPV co-infected women and for peri-anal warts in HIV/HPV co-infected men and women.