Update
$CEL-SCI (CVM.US)$ CEL-SCI Selects Ergomed as CRO as it Gears Up for Confirmatory FDA Registration Study of Multikine® in Head and Neck Cancer
4 MINUTES AGO, 6:00 AM EDT
VIA BUSINESSWIRE
As a clinical research organization (CRO) Ergomed has a strong track record with CEL-SCI in fast enrolment and high quality study delivery
CEL-SCI Corporation (NYSE:CVM) today announced its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection) in head and neck cancer.
Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market.
This partnership marks a continuation of the successful cooperation between the two companies, building on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer.
In addition to the positive outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy, CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
This confirmatory study represents a crucial step toward potential marketing approval of Multikine. The study, set to enrol 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on patients with no lymph node involvement and low PD-L1 tumour expression. Patients will be enrolled across multiple sites globally, underscoring the strength of Ergomed's global clinical trial management capabilities.
Geert Kersten, CEO of CEL-CI commented, "Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated. Their enrolment was fast and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries."
4 MINUTES AGO, 6:00 AM EDT
VIA BUSINESSWIRE
As a clinical research organization (CRO) Ergomed has a strong track record with CEL-SCI in fast enrolment and high quality study delivery
CEL-SCI Corporation (NYSE:CVM) today announced its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection) in head and neck cancer.
Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market.
This partnership marks a continuation of the successful cooperation between the two companies, building on their previous collaboration for the Phase 3 trial of Multikine, which was the largest study ever conducted in head and neck cancer.
In addition to the positive outcome from its recent meeting with the FDA regarding the path to approval for its first-line investigational cancer immunotherapy, CEL-SCI achieved other major milestones including receiving pediatric waivers from the UK's Medicines & Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).
This confirmatory study represents a crucial step toward potential marketing approval of Multikine. The study, set to enrol 212 newly diagnosed patients with locally advanced primary head and neck cancer, will focus on patients with no lymph node involvement and low PD-L1 tumour expression. Patients will be enrolled across multiple sites globally, underscoring the strength of Ergomed's global clinical trial management capabilities.
Geert Kersten, CEO of CEL-CI commented, "Ergomed is a trusted partner. Our past experience taught us that they are highly competent and motivated. Their enrolment was fast and the study was clean. The plan is for the study to commence in Q1 2025 in multiple countries."
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