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Randomized Controlled Trial
. 2018 May;36(5):801-809.
doi: 10.1007/s00345-018-2185-y. Epub 2018 Jan 29.

Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement

Neal Shore  1 , Ronald Tutrone  2 , Mitchell Efros  3 , Mohamed Bidair  4 , Barton Wachs  5 , Susan Kalota  6 , Sheldon Freedman  7 , James Bailen  8 , Richard Levin  9 , Stephen Richardson  10 , Jed Kaminetsky  11 , Jeffrey Snyder  12 , Barry Shepard  13 , Kenneth Goldberg  14 , Alan Hay  15 , Steven Gange  16 , Ivan Grunberger  17
Affiliations
Randomized Controlled Trial

Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement

Neal Shore et al. World J Urol. 2018 May.

Abstract

Purpose: These studies were undertaken to determine if fexapotide triflutate 2.5 mg transrectal injectable (FT) has significant long-term (LT) safety and efficacy for the treatment of benign prostatic hyperplasia (BPH).

Methods: Two placebo controlled double-blind randomized parallel group trials with 995 BPH patients at 72 sites treated 3:2 FT:placebo, with open-label FT crossover (CO) re-injection in 2 trials n = 344 and long-term follow-up (LF) 2-6.75 years (mean 3.58 years, median 3.67 years; FT re-injection CO mean 4.27 years, median 4.42 years) were evaluated. 12 months post-treatment patients elected no further treatment, approved oral medications, FT, or interventional treatment. Primary endpoint variable was change in Symptom Score (IPSS) at 12 months and at LF. CO primary co-endpoints were 3-year incidence of (1) surgery for BPH in FT treated CO patients versus patients crossed over to oral BPH medications and (2) surgery or acute urinary retention in FT-treated CO placebo patients versus placebo patients crossed over to oral BPH medications. 28 CO secondary endpoints assessed surgical and symptomatic outcomes in FT reinjected patients versus conventional BPH medication CO and control subgroups at 2 and 3 years.

Results: FT injection had no significant safety differences from placebo. LF IPSS change from baseline was higher in FT treated patients compared to placebo (median FT group improvement - 5.2 versus placebo - 3.0, p < 0.0001). LF incidence of AUR (1.08% p = 0.0058) and prostate cancer (PCa) (1.1% p = 0.0116) were both reduced in FT treated patients. LF incidence of intervention for BPH was reduced in the FT group versus oral BPH medications (8.08% versus 27.85% at 3 years, p < 0.0001). LF incidence of intervention or AUR in placebo CO group with FT versus placebo CO group with oral medications was reduced (6.07% versus 33.3% at 3 years, p < 0.0001). 28/28 secondary efficacy endpoints were reached in LF CO re-injection studies.

Conclusions: FT 2.5 mg is a safe and effective transrectal injectable for LT treatment of BPH. FT treated patients also had reduced need for BPH intervention, and reduced incidence of PCa and AUR.

Keywords: BPH; Fexapotide triflutate; LUTS; NX-1207; Urology.

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Conflict of interest statement

Conflict of interest

Authors Gange, Shore, Richardson, Kaminetsky and Tutrone are consultants/speakers for NeoTract. Authors Gange, Shore, Kaminetsky, Levin are consultants for NxThera. Author Kaminetsky is a consultant for Meditech. Author Shore, Tutrone, Bidair are consultants/speakers for Nymox. Authors Tutrone, Hay own stock in Nymox.

Statement of human rights

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Figures

Fig. 1
Fig. 1
CONSORT diagram of patient enrollment, allocations, treatment and follow-up
See this image and copyright information in PMC

Comment in

References

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