FDA greenlights CEL-SCI confirmatory study for Multikine By Investing.com

VIENNA, Va. – CEL-SCI Corporation (NYSE American: CVM) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s proposed patient selection criteria for a confirmatory Registration Study of its investigational cancer immunotherapy, Multikine. This follows the completion of a 928-patient Phase 3 study in advanced primary head and neck cancer, which demonstrated a significant survival benefit in a subset of patients.

The FDA’s go-ahead allows CEL-SCI to proceed with a 212-patient study focusing on newly diagnosed patients with no lymph node involvement and low PD-L1 tumor expression. This target group showed a 73% five-year survival rate with Multikine treatment compared to a 45% rate in the control group.

CEL-SCI CEO Geert Kersten expressed optimism, stating that the survival benefit observed in the Phase 3 study was so substantial that the upcoming study is adequately powered with fewer participants to confirm the findings. The company aims to initiate the confirmatory trial promptly.

The Phase 3 study, which was the largest of its kind in this patient population, has set a high bar for approval, especially since the treatment is intended for use prior to surgery. The FDA’s acknowledgment of the unmet need for improved therapies in this patient group adds weight to the potential approval of Multikine.

If Multikine is approved as a pre-surgical treatment, it could become part of the standard of care for the targeted patient population. The confirmatory study’s design, which includes a randomized controlled trial with two arms, aims to further validate the efficacy and safety of Multikine.

CEL-SCI believes that the confirmatory study is de-risked due to the robust data from the completed Phase 3 trial. The company has positioned itself as a Phase 3 oncology company with a strong value proposition for investors, emphasizing the long-term survival data demonstrated in the target patient population.

This announcement is based on a press release statement and does not constitute an endorsement of Multikine’s safety or efficacy, as the treatment has not yet been approved by the FDA or any other regulatory agency.

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As CEL-SCI Corporation (NYSE American: CVM) progresses with its confirmatory Registration Study for Multikine, the company’s financial health and market performance are pivotal for investors monitoring the…