Blue Earth Therapeutics has announced positive early data from its Phase 1 trial of Lutetium-177 rhPSMA-10.1 injection, an investigational radioligand therapy for prostate cancer. The trial, which completed enrollment in July, suggests an encouraging safety profile and favorable radiation dosimetry, paving the way for a Phase 2 study later this year.
Promising Phase 1 Results
Early data indicate that Lutetium-177 rhPSMA-10.1 delivers high tumor absorbed radiation doses relative to the dose delivered to key normal organs, such as the kidneys and salivary glands. According to the company, the ratio between radiation dose to tumors versus dose to the kidneys and salivary glands was compelling when compared to published data for first-generation radioligand therapies. These findings support the potential for improved efficacy and reduced toxicity compared to existing treatments.
Innovative Dosing Strategies for Phase 2
Based on the Phase 1 results, Blue Earth Therapeutics plans to explore innovative dosing regimens in the upcoming Phase 2 trial. These strategies include:
- Administering a significantly higher overall injected radioactivity compared to recent Phase 3 clinical trials of other agents.
- Front-loading of administered radioactivity.
- Extending the duration of administration of radioactivity to provide longer time on treatment.
The company believes that these factors, combined with the positive radiation dosimetry results seen in Phase 1, will further support the goal of delivering better outcomes for patients.
Expert Commentary
"We are excited by the new data which support our best-in-class thesis and to have a clear path to move from Phase 1 to Phase 2 in the development of our lead therapy," said David Gauden, CEO of Blue Earth Therapeutics. "We remain on track for the opening of Phase 2 in the next few months. We also expect to see the full Phase 1 results presented at a scientific meeting in 2025."
Dr. Daniel Stevens, Head of Clinical Development and Medical at Blue Earth Therapeutics, added, "The available science increasingly highlights that fixed dosing at fixed intervals is unlikely to be optimal. Front loading radioactivity and extending the time on therapy may lengthen time to disease progression. We will explore these concepts in Phase 2. Our intention is to optimize dosing now, with the aim of achieving the best possible outcomes for patients in a future pivotal trial. We think that adapting dosing based on data from the individual patient will be important for improved results."
Phase 2 Trial Design
The Phase 2 clinical trial of Lutetium-177 rhPSMA-10.1 Injection is planned to open at approximately 15 sites across the US and Europe and enroll approximately 70 patients. This trial aims to optimize dosing strategies to maximize efficacy and minimize toxicity, potentially leading to improved outcomes for patients with prostate cancer.
