Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug Application (IND) application for 177Lu-rhPSMA-10.1. IND authorization to proceed enables Blue Earth Therapeutics to initiate a Phase 1/2 clinical study to evaluate the safety, tolerability, dosimetry and anti-tumor activity of 177Lu-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-rhPSMA-10.1 is the first clinical candidate in Blue Earth Therapeutics’ oncology development program of next generation therapeutic radiopharmaceuticals. Blue Earth Therapeutics holds exclusive worldwide rights to therapeutic applications of radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) radiopharmaceutical technology to help advance the treatment of patients with prostate cancer.
To read the full article, click here.