Clinical Trial Update: A Look at Progress and the Road Ahead

Woman with cancer during chemotherapy recovering from illness in hospital

112

News May 1, 2025

As we move through spring 2025, our European clinical trial continues to evolve—growing in scope, complexity, and collaboration. Behind the numbers and timelines lies an ongoing story of scientific dedication, teamwork, and resilience across borders. With Phase A nearing completion in several locations and Phase B already underway in others, it’s the perfect time to reflect on the journey so far.

Phase A: Steady Gains Across Europe

Phase A began with an ambitious goal: enrolling 720 participants across 11 clinical sites. These are spread across Germany, Portugal, Lithuania, Romania, Greece, Bulgaria, the Czech Republic, and Hungary. While each site has had its own rhythm and operational challenges, the overall pace has been impressive.

At the Mainz University Medical Center (UMC) in Germany, Phase A recruitment was achieved ahead of schedule, hitting 115 participants by late April, with a particularly strong showing in March. This success didn’t happen overnight—it reflects months of groundwork, trust-building with patients, and coordination among site teams.

Portugal’s IPO site, always consistent in its approach, has led from the front with 145 Phase A participants. Recruitment there ramped up sharply in January, when over 50 participants were enrolled in a single month. IPO’s experience from previous trials likely contributed to their smooth process and strong patient engagement.

In Lithuania, the team at LSMU overcame a slow initial start and has since gained momentum. Their total now stands at 74 participants, with April marking their highest monthly enrolment yet. It’s a clear example of how persistence and local mobilization can overcome early hurdles.

Other sites are making solid progress, even if their journeys have just begun. Recruitment in Romania and Greece has started to pick up, while Bulgaria and several others are now actively screening participants. These new starts are critical to ensuring full geographic representation and meeting long-term targets.

One standout is Germany’s UKSH (Lübeck) site, which joined the trial slightly later and is progressing well toward its target of 400 participants by the end of next year. Their contribution has significantly bolstered the overall recruitment picture.

By the end of April, a total of 625 Phase A participants had been enrolled across all sites. It’s a remarkable milestone that brings us within reach of full Phase A completion.

Phase B: The Next Chapter Begins

With Phase A winding down at several locations, Phase B is already underway. This next phase carries a far more ambitious goal: 3,400 participants across the same site network, bringing the full trial target to over 4,000 individuals.

At Mainz, Phase B began in March and has already reached 139 enrolments. Portugal’s IPO site is not far behind, with 75 participants recruited since February. These early figures signal strong preparedness for the demands of Phase B, and they also reflect lessons learned from Phase A—especially in terms of workflow, communication, and participant follow-up.

Meanwhile, new activity is starting at other sites. In April, recruitment began at MMA (Medical Military Academy), where 16 participants were already enrolled in their first month—an encouraging start.

A Broader Perspective

Clinical trials are rarely linear. Delays, protocol adjustments, and regulatory challenges are part of the process. What stands out in this trial is the adaptability and commitment of the teams involved. From initial start-up to participant engagement, local teams have shown remarkable creativity and endurance.

It’s not just about hitting numbers—it’s about maintaining high-quality standards, ensuring participant safety, and building a platform for reliable, future-facing science. Every subject enrolled represents a life touched and a step closer to validating a therapeutic approach that could benefit many more.

What Comes Next?

Looking ahead, the focus is on:

Wrapping up Phase A enrolment at the remaining sites by mid-2025.
Expanding Phase B recruitment efforts across all participating countries.
Providing consistent monitoring and operational support to ensure smooth transitions and data integrity.

As the trial progresses, communication will continue to be central—not only within teams and between sites, but also with broader stakeholders who are invested in this study’s outcomes.

This trial is more than a set of milestones on a spreadsheet. It’s a pan-European collaboration driven by clinicians, researchers, and coordinators who believe in the potential impact of their work. We’ll continue sharing these updates as the journey unfolds—highlighting not just the results, but the real stories that power them.