clinical trials

We have completed eight clinical trials of PRX302 – including a Phase 2a trial for the treatment of localized prostate cancer (PRX302-2-7) and a Phase 3 trial l for the treatment of the lower urinary tract symptoms of BPH. In March 2017, we initiated a second Phase 2 clinical trial to confirm the dose and optimize the delivery of topsalysin for the treatment of clinically significant localized prostate cancer. In the PLUS-1 study, PRX302 also demonstrated a favorable safety profile, with no evidence of any treatment related sexual or cardiovascular side effects. The Phase 3 trial, called PLUS-1, achieved its primary endpoint — a single treatment with PRX302 (topsalysin) demonstrated a statistically significant improvement in BPH symptoms over a 12 month period. In our completed PRX302-2-7 PCA trial, the one-time administration of topsalysin was well tolerated with no serious adverse events and no new safety signals being reported. Topsalysin demonstrated an ability to ablate tumor cells in over 50 percent six months after treatment in a patient population with pre-identified, clinically significant prostate cancer. The results support advancing topsalysin for the treatment of localized prostate cancer into another Phase 2 study to confirm dose and optimize delivery.

On-going Clinical Development in Localized Prostate Cancer

Study Phase
(pts treated with PRX302
Trial Design
PRX302-2-8
Phase IIB
Approximately 40 patients Phase 2b 6 to 12 month trial with topsalysin in patients who have histologically proven, clinically significant localized prostate cancer to confirm the dose and optimize the delivery of a single and potentially a second transperineal intraprostatic treatment of topsalysin

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Completed Clinical Development in Localized Prostate Cancer

Study Phase
(pts treated with PRX302
Trial Design
PRX302-2-7 PCa IIa Completed (18 patients) Open label, Phase 2a study, evaluating the safety and tolerability of targeted intraprostatic administration of PRX302 to treat men with histologically proven, clinically significant, localized, low to intermediate risk prostate cancer
PRX302 PCa II (6 pts) Open-label clinical trial in locally-recurrent prostate cancer
PRX302 PCa I (24 pts) Open-label, safety and tolerability, dose escalation trial of PRX302 in patients with biopsy-proven, locally-recurrent prostate cancer

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Completed Clinical Development in BPH

Study Phase
(pts treated with PRX302
Trial Design
PLUS-1
PRX302-3-01 BPH
III Completed (479 patients) Prospective, randomized, double-blind, placebo-controlled, transrectal treatment of PRX302, which will utilize the IPSS outcome measure evaluated at 12 months as the primary endpoint
TRIUMPH
PRX302-2-03 BPH
IIb (61 pts) Randomized, double-blind, placebo-controlled, transperineal treatment of PRX302
PRX302-2-06 BPH I/II (32 pts) Randomized dose escalation, multicenter trial of a single transrectal intraprostatic treatment of PRX302
PRX302-2-02
Phase 2a BPH
IIa (18 pts) Open-label, safety, volume escalation clinical trial of a single transperineal treatment of PRX302
PRX302-2-01
BPH
I (15 pts) Open-label, safety, dose escalation clinical trial of a signal transperineal intraprostatic treatment of PRX302

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