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News  ›  GlobeNewswire Inc.

Theriva™ Biologics anuncia el asesoramiento científico favorable de la Agencia Europea de Medicamentos (EMA) sobre el diseño de un ensayo de fase III de VCN-01 en el adenocarcinoma ductal pancreático (ACDP) metastásico

GlobeNewswire Inc. Logo GlobeNewswire Inc. • •By Theriva Biologics, Inc.
Theriva™ Biologics anuncia el asesoramiento científico favorable de la Agencia Europea de Medicamentos (EMA) sobre el diseño de un ensayo de fase III de VCN-01 en el adenocarcinoma ductal pancreático (ACDP) metastásico

Theriva Biologics received favorable scientific advice from the European Medicines Agency (EMA) on the design of a Phase 3 clinical trial for VCN-01 in combination with gemcitabine/nab-paclitaxel for treating metastatic pancreatic ductal adenocarcinoma (PDAC). The EMA approved the proposed trial design, sample size, and adaptive design elements. The company plans to meet with the FDA in H1 2026 for a multinational Phase 3 trial and has cash runway through Q1 2027.

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The company received favorable regulatory guidance from the EMA on its lead candidate VCN-01, with approval of the Phase 3 trial design including sample size and dosing regimen. The EMA's recognition of improved survival outcomes with multiple VCN-01 doses and acceptance of repeated dosing cycles strengthens the development pathway. Planned FDA meeting in H1 2026 and adequate cash runway through Q1 2027 support near-term progress on pivotal trials.

Keywords
#VCN-01 #pancreatic cancer #Phase 3 trial #EMA approval #gemcitabine/nab-paclitaxel #oncolytic adenovirus #retinoblastoma #clinical development

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