CEL-SCI Corporation (NYSE American: CVM), biotechnology company that develops therapies to boost the immune system of cancer patients before surgery, radiation and chemotherapy, announced on Wednesday that it has achieved a significant milestone as the European Medicines Agency (EMA) Paediatric Committee has granted a product-specific waiver, exempting CEL-SCI from strict requirements for cancer drugs' commercialisation in the European Union (EU).

This waiver paves the way for marketing authorisation for Multikine, an investigational cancer immunotherapy targeting newly diagnosed adults (>18 years old) with locally advanced resectable primary squamous cell carcinoma of the head and neck (SCCHN).

The EU Paediatric Regulation, in effect since January 2007, aims to enhance the development of paediatric medicines. CEL-SCI's Multikine has demonstrated positive clinical outcomes in its Phase 3 study, showing pre-surgical responses leading to longer life, especially in low-risk patients. The recent waiver streamlines the regulatory process, allowing CEL-SCI to navigate marketing authorisation more efficiently.

Multikine, administered before surgery, aims to strengthen the immune system's response to tumours, potentially improving the overall survival rate. The Phase 3 study highlighted significant benefits, with patients experiencing pre-surgical responses showing a 72% likelihood of being alive after five years compared to control patients. The positive results were statistically significant, demonstrating the potential of Multikine in the targeted population.

CEL-SCI's regulatory strategy focuses on seeking immediate approval of Multikine, driven by the compelling patient need for pre-surgical responses and improved survival rates. The Phase 3 data indicate a transformative impact on the standard of care, offering patients a chance of over 70% survival at five years, a substantial improvement compared to the current 50/50 chance.