Nymozarfex (fexapotide) / Nymox - LARVOL DELTA

Nonsurgical Interventions to Prevent Disease Progression in Prostate Cancer Patients on Active Surveillance: A Systematic Review and Meta-analysis. (PubMed, Eur Urol Oncol) - "The use of 5-ARIs in PCa patients on AS is associated with longer PFS. However, for the other interventions, it is difficult to draw clear conclusions based on the weak available evidence."

Journal • Retrospective data • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Nymox Reports New NYMOZARFEX Marketing Application is Accepted For Review (GlobeNewswire) - "Nymox Pharmaceutical Corporation...is pleased to announce that the Company's recent submission of Fexapotide Triflutate for the treatment of symptoms of benign prostate enlargement (benign prostatic hyperplasia, referred to as BPH) has been validated by the U.K. authorities, at U.K. Medicines & Healthcare products Regulatory Agency (MHRA). The formal review process has now started. The trademarked name for the new product is NYMOZARFEX (TM). The Marketing Authorization Application (MAA) was submitted September 25, 2023. The new submission includes England, Wales, Scotland and Northern Ireland. The Company will continue to provide further information, including other expected submissions, when the information becomes available."

European regulatory • Benign Prostatic Hyperplasia • Urology

Nymox Reports Successful New NYMOZARFEX (TM) Long-Term Prostate Cancer Treatment Clinical Trial Results (GlobeNewswire) - P2 | N=146 | NCT01620515 | Sponsor: Nymox Corporation | "Nymox Pharmaceutical Corporation...is pleased to announce today important new long-term clinical trial results from the Company's 146 patient NX03-0040 NYMOZARFEX (TM) U.S. study for low grade localized prostate cancer. New long-term follow-up data from the prospective randomized clinical trial of NYMOZARFEX (TM) for low grade early prostate cancer has indicated that there is strong statistically significant benefit from the treatment compared to controls when all available patient outcomes were included from 18 months to as long as up to >10 years after treatment....The outcome comparisons showed greatly reduced percentages of subjects treated with NYMOZARFEX (TM) who had progressed by either cancer grade worsening or by prostate cancer surgery, radiotherapy, or chemotherapy; and which remained overall strongly statistically significant compared to the study's randomized controls (p<.01)."

P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Nymox Reports on U.S. Patent Issuances (GlobeNewswire) - "Nymox Pharmaceutical Corporation...is pleased to announce the Issuances of several of its important U.S. patents for NYMOZARFEX....In the U.S. alone, 5 new patents from January 2022 through the present time in 2023 alone have issued for the Company's main business concerns, including patents for the company's treatments for prostate enlargement (BPH) and prostate cancer."

Patent • Benign Prostatic Hyperplasia • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH (clinicaltrials.gov) - P3 | N=104 | Terminated | Sponsor: RECORDATI GROUP | N=340 ➔ 104

Enrollment change • Benign Prostatic Hyperplasia

Fexapotide triflutate vs oral pharmacotherapy as initial therapy for moderate-to-severe benign prostate hyperplasia patients: a cost-effectiveness analysis. (PubMed, BMC Urol) - "Compared to upfront oral pharmacotherapy options, FT would be cost-effective at a price per injection below $14,000, assuming a WTP threshold of $150,000 per QALY."

HEOR • Journal • Benign Prostatic Hyperplasia

Minimally Invasive Therapy: What Is The Status In 2021 - What's Coming, What's Going? (PubMed, Aktuelle Urol) - "For instance, transurethral needle ablation, transurethral microwave thermotherapy, intraprostatic botulinum toxin A or PRX302 injections as well as prostatic stents are no longer recommended. In contrast, the European Association of Urology is currently recommending UroLift, Aquablation and prostatic artery embolisation, which achieve significant long-term improvements in functional parameters while providing a good safety profile and preserved sexual function. Promising data are also available for the temporarily implanted nitinol device (iTIND), Rezūm, intraprostatic injection of fexapotide triflutate and transperineal laser ablation of the prostate, but the efficacy and safety of these procedures need to be confirmed in further studies."

Journal • Urology

"@clausroehrborn hello Dr. do you think that fexapotide has a real@chance of helping those w BPH? Thnx." (@gissaus)

"$NYMX Nymox Announces Date for Fexapotide Filing https://t.co/mcZfML7ErK" (@stock_titan)

A state-of-art review on the preservation of sexual function among various minimally invasive surgical treatments for benign prostatic hyperplasia: Impact on erectile and ejaculatory domains. (PubMed, Investig Clin Urol) - "These minimally invasive BPH therapies can be largely be divided into those with cavitating technology (Rezum, Histotripsy, Aquablation), intra-prostatic injections (Botulinum neurotoxin Type A, Fexapotide Triflutate, prostate specific antigen-activated protoxin PRX-302), and mechanical devices which include intraprostatic stents (Urospinal 2™, Memotherm™, Memokath™, and Allium triangular prostatic stent™) and intraprostatic devices (iTIND™, Urolift™), as well as prostatic artery embolization. Published literature on these technologies showed reasonable preservation of erectile function with limited data reported on ejaculatory domain. Further validation of the performance of these novel minimally invasive treatment options for LUTS due to BPH in well-designed and multi-centre studies are desired, to evaluate their role (or lack of such a role) in clinical practice and whether these BPH therapies can provide equivalent standard or better than TURP."

Journal • Review • Benign Prostatic Hyperplasia • Sexual Disorders

NYMOX Provides Current Update on Key Company Developments (GlobeNewswire) - "FT has shown long-term effectiveness for BPH without the distressing side effects often unavoidable with the available drugs and procedures. The results from the main U.S. multi-center randomized prospective blinded long-term studies of FT for BPH have been published in prestigious peer review journals including World Journal of Urology 2018 36: 801-809 (Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement authored by Neal Shore....Results from the large multi-center prospective long-term FT prostate cancer study were published in the peer review literature in the prestigious World Journal Of Urology 2020 in the report Prospective Evaluation of Fexapotide Triflutate Injection ‎Treatment of Grade Group 1 Prostate Cancer: Four Year Results authored by Neal Shore..."

Nymox announces new peer review publication of prostate cancer fexapotide clinical trial results in World Journal of Urology (GlobeNewswire) - "Nymox Pharmaceutical Corporation...is pleased to announce that a new peer review report was published today in the World Journal of Urology, documenting the successful long-term clinical trial results after Fexapotide Triflutate treatment for early stage prostate cancer....Important clinical highlights from the study include: FT treatment reduced cancer progression (-67.7%) compared to controls (3 years, FT 15mg, p<.02, pooled FT p=.0265) and also reduced (-54.7%) the incidence of surgery, radiotherapy or chemotherapy (4 years, FT 15mg p<.02; pooled FT p=.0374). At 4 years the incidence of surgery, radiotherapy or chemotherapy with increased Gleason grade was significantly reduced (FT 15mg -73.3% p=.0059, pooled FT p=.0064)."

Clinical data

Nymox provides update on current corporate activities and milestones (GlobeNewswire) - "A review article on the progress in the development of Fexapotide entitled 'Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia' authored by Neal Shore, MD, FACS..."

Review

Nymox announces new peer review article on fexapotide Pharmaco-ablation experimental studies published in research and reports in urology (Business Insider) - "A review article on the progress in the development of Fexapotide entitled 'Efficacy and safety of fexapotide triflutate in outpatient medical treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia' authored by Neal Shore..."

Media quote • Review