CEL-SCI Corporation reported it has filed a request with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer. At the meeting, CEL-SCI will present MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously. These new results arose from an improved selection algorithm of the Multikine target population.

The improvements in the selection algorithm were based on discussions and feedback from regulators and consultants. This pathway would allow CEL-SCI to request immediate approval based on the data generated to date, and any additional studies if needed would be done post-market. With the European Medicines Agency and the MHRA, company hope to do the same.

The company's pivotal Phase 3 study tested Multikine in newly diagnosed locally advanced head and neck cancer patients. The study demonstrated a nearly 4-year median overall survival benefit for Multikine treated patients who were treated with surgery and radiotherapy versus the control group who did not receive Multikine. The dire need for a new and effective treatment for newly diagnosed locally advanced primary head and neck cancer is widely recognized in the medical community.