Molecular Insight initiates Phase I prostate cancer trial

The trial is designed to investigate two small molecule radiopharmaceutical candidates that target prostate-specific membrane antigen, MIP-1072 and MIP-1095, in order to select a lead candidate for further development and commercialization. Molecular Insight is conducting the study under an exploratory investigational new drug application submitted to the FDA.

The trial, which will involve up to 12 patients, is a single-blind, randomized cross-over study. Patients will receive a single dose of MIP-1072 or MIP-1095, followed by a single dose of the alternate candidate compound 14 days later.

The primary objective of the trial is to evaluate the pharmacokinetics and organ radiation dosimetry of the two compounds in patients diagnosed with prostate cancer who have evidence of recurrent metastatic disease. Secondary objectives include assessments of excretion, metabolism, safety and optimization of tumor imaging parameters.

David Barlow, chairman and CEO of Molecular Insight, said: “Trofex expands our oncology portfolio into the arena of molecular imaging radiopharmaceuticals for the detection, monitoring and staging of disease such as prostate cancer, providing an important strategic complement to our portfolio of molecular radiotherapeutics for cancer.”