CEL-SCI requests to discuss pathway for Multikine immunotherapy with MHRA

CEL-SCI reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, or MHRA, to discuss a pathway for approval of Multikine 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 improved selection algorithm is able to more accurately predict the patients who would benefit most from the Multikine therapy. A statistical validation of outcomes in the new target population, based on the Phase 3 study data, was recently concluded and will be presented at the Conference of the European Society for Medical Oncology, or ESMO, which takes place October 20-24 in Madrid, Spain.