Pivotal supports expansion of enGene Clinical Trial for bladder cancer treatment into Europe

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 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.  

About Pivotal

Pivotal was born and raised in 2001 surrounded by an environment of high scientific tenure and drive. Our founder, Dr. Ibrahim Farr, launched Pivotal to share and implement scientific strategies and best project practices that make clinical trials more efficient and maximize our client’s drug development programs’ value chain. As a company with some 200 employees and operating in more than 20 countries we have built focused specialization across all therapeutic areas and founded a strong innovative therapies and early phases hub that enables us to tackle our customers most difficult challenges. After almost a quarter of a century of hands-on experience, we master clinical research.

Pivotal has forged an aspirational vision of a digitally and data-enabled, growth-oriented future. We dive deep into clinical trials by leveraging our near real time advanced insights platform. We discover data-driven insights to anticipate trial risks and predict their impact. This has made us an efficient, agile and resilient company, very focused on our customers. We are a technology-savvy organization.

For more information, please visit www.pivotalcr.com and follow us on LinkedIn.