Pivotal supports expansion of enGene Clinical Trial for bladder cancer treatment into Europe
- Pivotal leverages its expertise in advanced therapies clinical development to expand enGene Non-Muscle Invasive Bladder Cancer trial
- Collaboration applies to sites across Spain, Germany, Italy, France and United Kingdom
Pivotal, a leading clinical Contract Research Organisation (CRO), today announced its support for enGene’s expansion of their Phase 2 registrational trial of detalimogene voraplasmid for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) into Europe.
Pivotal is providing enGene broad clinical trial support in Europe, including regulatory affairs, clinical operations, pharmacovigilance and medical monitoring services. The collaboration applies to sites across five countries in Europe: Spain, Germany, Italy, France and United Kingdom.
“enGene is thrilled to expand our trial to multiple countries in Europe, where we now have investigative sites open and actively screening and enrolling new patients,” said Jill Buck, enGene’s Senior Vice President of Clinical Development Operations.
Detalimogene voraplasmid is an investigational, non-viral gene therapy being studied for the treatment of NMIBC. The trial focuses on patients with NMIBC who are Bacillus Calmette-Guérin (BCG)-naïve or unresponsive to or ineligible for BCG therapy, a standard treatment currently facing supply shortages.
“We are proud to partner with enGene in this important Pivotal trial,” said Lourdes Huarte, MPharm, PhD, MBA, Senior Vice President Regulatory & Clinical Operations of Pivotal. “Our expert team is dedicated to providing the resources and expertise necessary to advance this promising clinical program for NMIBC patients. We look forward to contributing to enGene’s clinical and regulatory milestones.”
This collaboration underscores Pivotal’s commitment to support biotech innovators in the development of cutting-edge therapies that address urgent unmet medical needs and bring new treatment options to patients in Europe and worldwide.
MEDIA CONTACT
Ms. Natalia Farr
natalia.farr@pivotalcr.com