Protox Therapeutics Inc. (TSX-V:PRX), a Canadian biotech company, announced that it will proceed with one of three scheduled Phase 2a clinical trials evaluating PRX302 for the treatment of localized recurrent prostate cancer. Protex has begun the process of patient screening for the trial.
The Phase 2a study is designed to optimize dosing in order to fully
exploit the therapeutic potential of PRX302, while maintaining its safety profile.
The company reported favorable results from a recently
completed Phase 1 study. PRX302, a targeted PSA activated pore-forming pro-toxin that has shown promising signs of clinical and biologic activity in two Phase 1 trials.
The company feels that PRX302 represents a significant opportunity for
the treatment of not only prostate cancer, but also BPH.
This trial will be composed of up to 30 patients with recurrent localized prostate cancer following primary radiation therapy. The trial will be single-arm (no placebo), open-label, multi-center study. The trial is designed to determine the optimal injection regimen that provides the best therapeutic benefit while maintaining safety and tolerability.
The planned measure of therapeutic activity will be based on changes in PSA levels, PSA doubling time and tumor burden.
PRX302 is the lead drug candidate in the company’s PORxin(TM) technology platform. PORxin drugs are pro-drugs that are activated by specific proteases produced at elevated levels on the surface of target cells. PRX302 has been generated by engineering the naturally occurring toxin proaerolysin to create a potent agent with a distinct mode of action. The drug has been engineered so that it is activated by prostate-specific antigen (PSA), an enzyme that is overproduced in patients suffering from prostate cancer and BPH (benign
prostatic hyperplasia or enlarged prostate). Once activated, the drug punches holes in the target cells causing the contents to leak out and ultimately cell death.
The company has a very interesting graphic display at which explains the method of action of PRX302.
Joel T Nowak MA, MSW