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news.US-based biotechnology firm CEL-SCI has received clearance from the Ministry of Health Malaysia to start patient enrollment in the Phase III trial of its investigational cancer immunotherapy Multikine (Leukocyte Interleukin, Injection) in Malaysia to treat head and neck cancer.
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Malaysia is the 20th country to approve the company’s Phase III trial, which has now enrolled more than 350 patients with advanced primary, not yet treated, head and neck cancer.
CEL-SCI chief executive officer Geert Kersten said: "Our plan called for having the trial cleared and conducted in a total of 21 countries, the US plus 20 other countries."
The trial’s objective is to show a 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.
Patient enrollment in the open-label, randomized, controlled, global Phase III head and neck cancer trial is expected to be completed by the end of 2015.
In October 2013, the company had signed a CRADA with the US Naval Medical Center, San Diego, for the development of Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts.
Additionally, the company has 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.