Phase 1 section of Phase 1/2 clinical trial has completed enrolment: transition to Phase 2 underway Clear regulatory feedback received on proposed Phase 2 study design opens new opportunities for innovative dosing regimens vs first generation radioligand therapies OXFORD, United Kingdom , Oct. 8, 2024 /PRNewswire/ -- Blue Earth Therapeutics Ltd, an emerging leader in the development of therapeutic radiopharmaceuticals, today announced further positive developments for its novel investigational radioligand therapies. Enrolment of patients in the Phase 1 trial of Lutetium ( 177 Lu) rhPSMA-10.
1 Injection was completed in July. Early data from the trial suggests an encouraging safety profile. Radiation dosimetry performed for up to three cycles showed delivery of high tumour absorbed radiation doses relative to the dose delivered to the key normal organs, such as kidney and salivary glands.
While final analysis is ongoing, the ratio between radiation dose to tumours vs. dose to the kidneys and salivary glands was compelling vs. published data 1 for first generation radioligand therapies.
This data opens the way for the Phase 2 portion of the Phase 1/2 trial to start later this year. The company has shared the intended Phase 2 study design with regulators and, subject to trial safety committee agreement, will test innovative dosing regimens in the Phase 2 study. Based on the advantageous results for absolute tumour and normal organ uptake seen in Phase 1, the Phase 2 study will ex.
