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

Neal Shore, Ronald Tutrone, Mitchell Efros, Mohamed Bidair, Barton Wachs, Susan Kalota, Sheldon Freedman, James Bailen, Richard Levin, Stephen Richardson, Jed Kaminetsky, Jeffrey Snyder, Barry Shepard, Kenneth Goldberg, Alan Hay, Steven Gange, Ivan Grunberger

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1-9
Number of pages9
JournalWorld Journal of Urology
DOIs
StateAccepted/In press - Jan 29 2018

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Prostatic Hyperplasia
Prostate
Placebos
Safety
Injections
Incidence
Therapeutics
Prostatic Neoplasms
Urinary Retention

Keywords

  • BPH
  • Fexapotide triflutate
  • LUTS
  • NX-1207
  • Urology

ASJC Scopus subject areas

  • Urology

Cite this

Fexapotide triflutate : results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement. / Shore, Neal; Tutrone, Ronald; Efros, Mitchell; Bidair, Mohamed; Wachs, Barton; Kalota, Susan; Freedman, Sheldon; Bailen, James; Levin, Richard; Richardson, Stephen; Kaminetsky, Jed; Snyder, Jeffrey; Shepard, Barry; Goldberg, Kenneth; Hay, Alan; Gange, Steven; Grunberger, Ivan.

In: World Journal of Urology, 29.01.2018, p. 1-9.

Research output: Contribution to journalArticle

Shore, N, Tutrone, R, Efros, M, Bidair, M, Wachs, B, Kalota, S, Freedman, S, Bailen, J, Levin, R, Richardson, S, Kaminetsky, J, Snyder, J, Shepard, B, Goldberg, K, Hay, A, Gange, S & Grunberger, I 2018, 'Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement', World Journal of Urology, pp. 1-9. https://doi.org/10.1007/s00345-018-2185-y
Shore, Neal ; Tutrone, Ronald ; Efros, Mitchell ; Bidair, Mohamed ; Wachs, Barton ; Kalota, Susan ; Freedman, Sheldon ; Bailen, James ; Levin, Richard ; Richardson, Stephen ; Kaminetsky, Jed ; Snyder, Jeffrey ; Shepard, Barry ; Goldberg, Kenneth ; Hay, Alan ; Gange, Steven ; Grunberger, Ivan. / Fexapotide triflutate : results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement. In: World Journal of Urology. 2018 ; pp. 1-9.
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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.",
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T2 - results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement

AU - Shore, Neal

AU - Tutrone, Ronald

AU - Efros, Mitchell

AU - Bidair, Mohamed

AU - Wachs, Barton

AU - Kalota, Susan

AU - Freedman, Sheldon

AU - Bailen, James

AU - Levin, Richard

AU - Richardson, Stephen

AU - Kaminetsky, Jed

AU - Snyder, Jeffrey

AU - Shepard, Barry

AU - Goldberg, Kenneth

AU - Hay, Alan

AU - Gange, Steven

AU - Grunberger, Ivan

PY - 2018/1/29

Y1 - 2018/1/29

N2 - 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.

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KW - Fexapotide triflutate

KW - LUTS

KW - NX-1207

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