'A 7.60 point improvement in IPSS total score over 12 months indicates that patients are experiencing a significant relief of their BPH symptoms and improvement in their quality of life following a single treatment with PRX302,' said Dr.
Efficacy Analysis
The primary efficacy endpoint of the IPSS total score change from baseline over 52 weeks was analyzed, per guidance from the
In a secondary efficacy analysis of IPSS total score using an ANCOVA model and LOCF (Last Observation Carried Forward) to impute missing post-baseline data, the improvement in IPSS for PRX302 was well sustained over the 52 weeks following the single administration. The maximal effect of 8.31 points improvement in IPSS vs vehicle 6.89 points (p = 0.012) was achieved at Week 18 with 8.04 points of improvement for PRX302 still remaining at Week 52 vs 6.64 points for patients treated with vehicle only (p = 0.022) representing an end-of-study preservation of 97% of the peak benefit.
'The combination of the efficacy and safety profile makes PRX302 a particularly compelling potential option for men suffering from BPH and may help men avoid more invasive, surgical procedures,' said
Secondary efficacy endpoints included analysis of Qmax (maximum urine flow) change from baseline over 52 weeks by the repeated measures linear mixed model, which showed overall improvement of 1.77 mL/sec for PRX302, representing a statistical trend that narrowly missed statistical significance (p = 0.055) compared to the vehicle group.
An additional efficacy endpoint was the patient self-assessment of disease specific Quality of Life. On the 0 to 6 point Quality of Life (QOL) from the IPSS questionnaire, the PRX302 average change from the 4.5 point baseline was a sustained 1.6 to 1.7 points improvement from Weeks 18 through 52, which was statistically significantly superior to vehicle for every post-baseline visit beginning at Week 18 (reaching p = 0.004).
Safety Analysis
PRX302 treatment was generally well-tolerated, and no patient was withdrawn from the study or had their study drug injection altered because of an adverse event (AE). The safety profile was consistent with that reported in the TRIUMPH Phase 2 trial published in the
Adverse Events Occurring in >5% of Patients Treated with PRX302 (Safety Population)
Reported Any Time over the Entire 52 Weeks of Study and Regardless of Assessed Relatedness to Study Treatment:
Adverse Event(1) | Vehicle (N=240) n (%) | PRX302 (N=239) n (%) | ||||||
Dysuria (e.g., burning, pain, or discomfort on urination) | 20 (8.3) | 48 (20.1) | ||||||
Haematuria (microscopic or visible red blood cells in urine) | 36 (15.0) | 45 (18.8) | ||||||
Pollakiuria (frequent urination) | 14 (5.8) | 23 (9.6) | ||||||
Pyrexia (fever) | 10 (4.2) | 21 (8.8) | ||||||
Perineal Pain | 13 (5.4) | 21 (8.8) |
1(MedDRA Dictionary Preferred Terms)
The incidence of serious AEs (SAEs) was similar in both treatment groups. There were two SAEs assessed by the Investigator as at least possibly related to treatment for PRX302 and one such SAE for vehicle. The PRX302-related SAEs were moderate events of 'acute non-infectious prostatitis' and 'fever following prostate procedure' not unexpected manifestations of the intraprostatic cellular destruction and resultant inflammation integral to the PRX302 mechanism of action. The vehicle-related SAE was a mild event of 'urinary tract infection.'
PLUS-1 Study Background
The Phase 3 'PLUS-1' study is an international, multicenter, randomized, double-blind, and vehicle-controlled trial to assess the efficacy and safety of a single intraprostatic administration of PRX302 (0.6 mg/g prostate) for the treatment of BPH. Patients were randomized in a 1:1 ratio to either PRX302 or vehicle-only injection, and then monitored for 1 year. A total of 479 patients with moderate to severe BPH were enrolled and dosed by
Treatment groups were well balanced at baseline, including average IPSS total score (21.2 points both groups), Qmax (maximum urine flow) (9.5 mL/sec both groups), total prostate volume (49.8 mL for PRX302 vs. 48.1 mL vehicle), prior BPH treatment (55.2% PRX302 vs. 55.1% vehicle), and quality of life (4.5 points both groups, 'mostly dissatisfied' to 'unhappy' with current urinary condition).
About PRX302
PRX302 (topsalysin) is a modified recombinant protein that has been engineered to be selectively activated by an enzyme in the prostate, leading to localized cell death and tissue disruption without damaging neighboring tissue and nerves. PRX302 binds to the GPI-anchored receptors on the cell surface of prostate cells. Once activated by PSA, PRX302 combines with other activated PRX302 molecules, forming stable transmembrane pores that induce cell death. The prostate specific activation of PRX302 by enzymatically active PSA thus limits exposure of non-prostate tissues to the drug's activity, contributing to the safety of the therapy.
About BPH Market Opportunity
Our market research suggests that as many as 36 million men in
About Sophiris
Certain statements included in this press release may be considered forward-looking, including the quotes of Sophiris' President and CEO and our COO and head of research and development and any expectations relating to future development of PRX302 for the treatment of symptoms of BPH, including a second Phase 3 clinical trial necessary to pursue registration of PRX302, the results of the Phase 2a proof of concept trial for the treatment of localized low to intermediate risk prostate cancer l or Sophiris' capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Some of the risks and uncertainties that could cause actual results, performance or achievements to differ include without limitation, risks associated with the process of developing, manufacturing commercial scale drug products, obtaining regulatory approval of and commercializing treatments that are safe and effective and risks relating to raising sufficient capital to fund development and commercialization of drug products. All forward-looking statements are based on Sophiris' current beliefs as well as assumptions made by and information currently available to Sophiris and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, clinical trial results, market acceptance, ability to raise capital and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by Sophiris in its public securities filings; actual events may differ materially from current expectations. Sophiris disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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Canale Communications | NATIONAL Equicom |
Corporate Communications and IR | Investor Relations |
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