Dr. Giovanni Selvaggi Joins CEL-SCI as Clinical Advisor

CEL-SCI Corporation has announced the addition of Dr. Giovanni Selvaggi as a Clinical Advisor. Dr. Selvaggi, an esteemed oncology expert, will assist CEL-SCI in advancing its immunotherapy drug, Multikine, designed for head and neck cancer treatment. The company recently received approval from the U.S. Food and Drug Administration (FDA) to proceed with a confirmatory Registration Study for Multikine.

Multikine is unique as the first investigational cancer drug administered before any other standard treatments in newly diagnosed head and neck cancer patients. It is a pro-inflammatory cytokine that stimulates the immune system to combat cancer cells. Multikine is administered immediately after diagnosis, leveraging the immune system’s peak strength. Extensive studies involving 750 patients have confirmed the drug's safety and efficacy.

The FDA has endorsed a 212-patient study to verify Multikine's effectiveness, based on compelling data. Key findings include no significant safety concerns compared to standard treatment and a remarkable 73% five-year survival rate for patients treated with Multikine, versus 45% for those in the control group. Additionally, the drug halved the five-year mortality risk from 55% to 27%, with a statistically significant p-value of 0.0015.

Dr. Selvaggi, based in the U.S., brings a wealth of experience in drug development, cancer research, and strategic advisement for pharmaceutical and biotech companies. He currently serves as Chief Medical Officer at Xcovery Holdings and holds advisory roles in several other organizations. His notable achievements include pivotal roles in the approval of several cancer drugs, such as Zykadia for Novartis and Opdivo for Bristol Myers Squibb. Dr. Selvaggi earned his medical degree from the University of Torino and has a history of clinical trial participation and thoracic oncology practice.

Expressing enthusiasm about joining CEL-SCI, Dr. Selvaggi emphasized Multikine’s potential to prolong survival in newly diagnosed head and neck cancer patients. He highlighted the critical importance of early cancer treatment and affirmed his commitment to advancing Multikine through its expedited registrational path, with the aim of offering a potential cure.

Geert Kersten, CEO of CEL-SCI, welcomed Dr. Selvaggi, praising his dedication to cancer drug development and his extensive experience in clinical trials and regulatory processes. Kersten believes Dr. Selvaggi’s involvement will be invaluable as CEL-SCI progresses with the final stages of the Multikine study.

CEL-SCI's approach centers on enhancing the immune system's ability to fight cancer while it remains relatively intact. Multikine aims to target tumors effectively during this period. The drug has been administered to over 750 patients and has earned FDA Orphan Drug designation for neoadjuvant therapy in head and neck cancer. With a demonstrated five-year survival rate of 73% compared to 45% in controls, the FDA has approved a focused 212-person confirmatory Registration Study, enrolling newly diagnosed advanced primary head and neck cancer patients without lymph node involvement and exhibiting low PD-L1 tumor expression. This population represents a significant patient group annually.

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