UK Regulator Grants CEL-SCI Pediatric Waiver for Multikine®

CEL-SCI Corporation announced that the United Kingdom’s Healthcare Products Regulatory Agency (MHRA) has granted a product-specific waiver for their treatment, Multikine (Leukocyte Interleukin, Injection), for head and neck cancer in patients up to 18 years old. This waiver means that CEL-SCI is not required to conduct pediatric trials for Multikine as part of the licensing and marketing review process in the UK. This development is expected to expedite CEL-SCI's path to gaining marketing approval in the UK.

Geert Kersten, CEO of CEL-SCI, expressed satisfaction with the MHRA’s decision, stating that this positive feedback from the UK regulatory body aligns well with the company's preparations for their confirmatory FDA Registration Study in the U.S. and other regions. He emphasized that the pediatric waiver will hasten the marketing approval process for Multikine in the UK.

CEL-SCI Corporation focuses on enhancing the immune system's ability to attack cancer while it is still relatively intact. Their flagship product, Multikine, is designed to boost the immune system to target tumors effectively when the immune system is in a better state to combat the disease. Multikine has been administered to over 740 patients and has obtained Orphan Drug designation from the FDA for the neoadjuvant therapy of squamous cell carcinoma of the head and neck. Clinical trials have shown that Multikine significantly improves survival rates, with a 73% survival rate in targeted patient groups compared to 45% without the treatment five years post-therapy.

With these promising results, the FDA has agreed to CEL-SCI’s patient selection criteria and approved a focused confirmatory Registration Study. This study will involve 212 patients diagnosed with locally advanced primary head and neck cancer without lymph node involvement, as determined by PET scans, and exhibiting low PD-L1 tumor expression, as determined by biopsy. This targeted demographic represents over 100,000 patients globally each year.

CEL-SCI operates primarily out of Vienna, Virginia, with additional operations near Baltimore, Maryland. 

This waiver from the UK's MHRA is a crucial step for CEL-SCI as it simplifies the regulatory pathway, allowing the company to focus its resources on bringing Multikine to market more swiftly. The waiver not only recognizes the potential of Multikine in treating head and neck cancer but also supports CEL-SCI’s broader strategy to introduce this therapy across different regions, starting with the upcoming FDA Registration Study in the U.S.

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