Molecular Insight Pharmaceuticals (MIP) has initiated a Phase 2 clinical trial of its prostate cancer molecular imaging agent, ^99mTc-MIP-1404, which is being developed to detect the location and extent of prostate cancer in men who are newly diagnosed or have recurrent or progressive disease.

The company said MIP-1404 is a small molecule leveraging its single amino acid chelate technology and binds to the extracellular enzymatic domain of prostate-specific membrane antigen (PSMA) . PSMA is a protein found on the surface of approximately 95 percent of prostate cancer cells and is a target for the detection of primary and metastatic prostate cancer. Upon binding to PSMA, MIP-1404 selectively concentrates in prostate cancer cells allowing them to be visualized, said the Cambridge, Mass.-based MIP.  

This is a Phase 2 international multi-center open-label study of up to 120 high-risk prostate cancer patients scheduled for a clinically-indicated prostatectomy and extended pelvic lymph node dissection. Patients will receive a single intravenous dose of ^99mTc-MIP-1404 followed by SPECT/CT scan three to six hours after administration. Imaging will be performed within three weeks of scheduled prostatectomy and extended pelvic lymph node dissection. The ^99mTc-MIP-1404 image data will be evaluated for tissue distribution of the drug and the ability to detect prostate cancer within the prostate gland and lymph nodes. The extent and location of prostate cancer within the prostate gland and the ability to detect the presence of metastatic prostate cancer within pelvic lymph nodes will also be assessed. The imaging results will be compared with histopathology results as the truth standard. Clinical safety of ^99mTc-MIP-1404 also will be assessed.

This company-sponsored trial will be conducted at approximately 10 sites within the U.S. and at approximately 25 sites in Western, Central and Eastern Europe as well as in Russia.