Vancouver, BC – August 18, 2004 – Biotech company Protox Therapeutics says it has retained preclinical contract research organization CTBR (ClinTrials BioResearch) to conduct expanded preclinical and toxicology trials of PSA-PA1. The product is in development for treating localized prostate cancer. The company says it expects to lead to an investigational new drug application with the United States FDA and Phase I human trials by mid-2005.
“Expanded preclinical trials are a critical component in the preparation of an investigational new drug application with the FDA,” says Tazdin Esmail, the company’s president and CEO. “One of the main reasons the company selected CTBR for this work is their reputation in generating on-time reports and their strong working relationship with the FDA."