Progenics Pharmaceuticals announced that its first patient has been dosed in the company's phase 2/3 clinical trial of PSMA-Target PET/CT imaging agent, PyL, which it will be evaluating for diagnostic accuracy.
Progenics Pharmaceuticals, which develops medicine and other products targeting the treatment of cancer, dosed their first patient at Yale School of Medicine and plans to enroll about 300 patients with high risk prostate cancer with recurrence or metastatic disease in the U.S. and Canada for this part of the study.
“There exists a significant need for approved molecular imaging modalities with both high sensitivity and specificity to detect high risk recurrent or metastatic prostate cancer early,” said Lawrence Saperstein, MD, assistant professor, chief of the nuclear medicine and program director at Yale University School of Medicine. “We believe PyL, when used with a PET/CT scan, can provide treating physicians with more accurate disease detection, potentially leading to earlier diagnoses, more informed treatment decisions as well as the ability to monitor responses, and ultimately improved patient outcomes.”
In addition to the primary endpoint of assessing PyL PET/CT imaging to detect prostate cancer in areas of prostate gland and regional lymph nodes, researchers will also review the sensitvity in sites of metastasis or recurrence. The secondary endpoint of the study will take into consideration safety, tolerability, detection rate and pharmacokinetic parameters.
“This trial initiation represents a significant milestone for our PyL program, and is designed to help support registration of this novel imaging agent,” stated Mark Baker, Progenics CEO. “The early clinical data for PyL have been quite impressive, underscoring its potential to transform disease management for prostate cancer, and we look forward to further demonstrating its diagnostic performance as we advance the trial.”