Greenwich LifeSciences Expands Flamingo-01 Trial to Poland: A Strategic Move for Accelerated Patient Recruitment and Cost Optimization

Greenwich LifeSciences (Nasdaq: GLSI) has announced the activation of clinical sites in Poland for its Phase III clinical trial, FLAMINGO-01, which evaluates GLSI-100 immunotherapy for breast cancer recurrence prevention. This strategic expansion could significantly accelerate patient recruitment and potentially impact the overall trial timeline. Here's how the move to Poland could enhance the trial's robustness and potential success:

1. Substantial Patient Pool: Poland recorded 24,599 new breast cancer cases in 2022, providing a substantial patient pool for the trial. This large patient population can help accelerate enrollment and reduce the time required to reach the target number of patients.
2. Efficient Enrollment: Poland's centralized healthcare system and large treatment centers are known for efficient patient enrollment, often achieving recruitment rates 2-3 times faster than Western European sites. This efficiency can help expedite the trial's timeline.
3. Cost Optimization: Polish clinical sites typically operate at 30-40% lower costs compared to Western European or US sites. This cost optimization can help improve trial economics and potentially reduce the overall trial budget.
4. Diverse Patient Recruitment: The collaboration with Dr. Wysocki's network of 9-11 sites provides access to both academic and private centers, enabling diverse patient recruitment. This diversity can help ensure a more representative patient population and enhance the trial's validity.
5. Geographic Diversification: The inclusion of Polish sites helps mitigate single-region enrollment risks and strengthens the global applicability of eventual results. This diversification can enhance the trial's robustness and potential success.
6. First Patient Treated in 2024: The timing of this expansion, with the first patient treated in Poland in 2024, suggests that Greenwich LifeSciences is maintaining momentum in its Phase III program. This development could positively impact the overall trial timeline and potentially accelerate the path to potential commercialization if the therapy proves successful.



Expanding the trial to Poland offers several strategic advantages, including a substantial patient pool, efficient patient enrollment, lower costs, diverse patient recruitment, and geographic diversification. These factors, combined with the specific data and examples provided in the materials, demonstrate how the move to Poland could enhance the trial's robustness and patient recruitment.

In conclusion, the activation of clinical sites in Poland for the FLAMINGO-01 Phase III trial represents a strategic expansion that could significantly accelerate patient recruitment, optimize trial economics, and strengthen the trial's robustness. This move could positively impact the overall trial timeline and potentially enhance the therapy's chances of success.