"In preclinical studies, both MIP-1072 and MIP-1095 have demonstrated promising attributes, such as high affinity for PSMA, significant uptake into tumor cells and favorable clearance from normal tissues," said John W. Babich, Ph.D., President and CSO of Molecular Insight. "The exploratory IND process accelerated our entry into the clinic to evaluate which compound is the more promising for further development. We plan to complete this study in the second half of 2008 and then, once initial safety and imaging efficacy criteria are met, advance the selected lead candidate into expanded Phase 2 clinical development." Dr. Babich noted that preclinical data in support of MIP-1072 and MIP-1095 were presented in October 2007 at the AACR-NCI-EORTC meeting on "Molecular Targets and Cancer Therapeutics."
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 study is being conducted at Duke University Medical Center, New York Presbyterian Hospital-Cornell Medical Center and Johns Hopkins Hospital.
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.
|Contact: Priscilla Harlan|
Edelman Public Relations