Efficacy and Safety of a Single Transrectal Ultrasound(TRUS)-Guided Intraprostatic Injection of NX-1207 in Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Phase III European Study

The purpose of the this international, multicenter, randomised, single-blind, parallel group, Phase III study is to demonstrate that a single transrectal ultrasound (TRUS)-guided intraprostatic injection of NX-1207 provides a long lasting therapeutic improvement of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in patients not adequately controlled by medical therapy with α-blockers, as assessed by a change from baseline in the International Prostate Symptom Score (IPSS) total score.

Start Date01 Sep 2013

Sponsor / Collaborator-

EUCTR2012-002451-41-DE / Not yet recruitingPhase 3

EFFICACY AND SAFETY OF A SINGLE TRUS-GUIDED INTRAPROSTATIC INJECTION OF NX-1207 IN PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA: A PHASE III EUROPEAN CLINICAL STUDY

Start Date21 Aug 2013

Sponsor / Collaborator

Recordati SpA

NCT01846793 / CompletedPhase 3

Phase 3 Multicenter Prospective Open Label Clinical Safety Evaluation of Re-Injection of NX-1207 for the Treatment of BPH: Two Doses 1-8 Years Apart

This study is designed to demonstrate the safety and efficacy of a second transrectal intraprostatic injection of NX-1207 given to subjects with Benign Prostatic Hyperplasia (BPH) who previously received an injection of NX-1207 in an earlier U.S. clinical trial of NX-1207.

Start Date01 Apr 2013

Sponsor / Collaborator

Nymox Pharmaceutical Corp.

100 Clinical Results associated with Fexapotide triflutate(Nymox Pharmaceutical Corp.)

100 Translational Medicine associated with Fexapotide triflutate(Nymox Pharmaceutical Corp.)

100 Patents (Medical) associated with Fexapotide triflutate(Nymox Pharmaceutical Corp.)

Literatures (Medical) associated with Fexapotide triflutate(Nymox Pharmaceutical Corp.)

01 Dec 2022·BMC UrologyQ4 · MEDICINE

Fexapotide triflutate vs oral pharmacotherapy as initial therapy for moderate-to-severe benign prostate hyperplasia patients: a cost-effectiveness analysis

Q4 · MEDICINE

ArticleOA

Author: Hay, Alan R ; Wei, Yifan ; Suen, Sze-Chuan ; Hay, Joel W

Abstract:

Background:

To assess the price range in which fexapotide triflutate (FT), a novel injectable, is cost-effective relative to current oral pharmacotherapy (5 α-reductase inhibitor, α-blocker, 5 α-reductase inhibitor and α-blocker combination therapy) as initial therapy followed by surgery for moderate-to-severe benign prostate hyperplasia patients with lower urinary tract symptoms (BPH-LUTS).

Methods:

We developed a microsimulation decision-analytic model to track the progression of BPH-LUTS and associated costs and quality-adjusted life years in the target population. The cost-effectiveness analysis was performed from Medicare’s perspective with a time horizon of 4 years using 2019 US dollars for all costs. The microsimulation model considered treatment patterns associated with nonadherence to oral medication and progression to surgery. Model parameters were estimated from large randomized controlled trials, literature and expert opinion. For each initial treatment option, simulations were performed with 1000 iterations, with 1000 patients per iteration.

Results:

Three upfront oral pharmacotherapy options are close in cost-effectiveness, with combination therapy being the most cost-effective option. Relative to upfront oral pharmacotherapy options, FT slightly increases quality-adjusted life years (QALY) per patient (1.870 (95% CI, 1.868 to 1.872) vs. 1.957 (95% CI, 1.955 to 1.959) QALYs). Under the willingness-to-pay (WTP) threshold of $150,000 per QALY, at price per injection of $14,000, FT is about as cost-effective as upfront oral pharmacotherapy options with net monetary benefit (NMB) $279,168.54. Under the WTP threshold of $50,000 per QALY, at price per injection of $5,000, FT is about as cost-effective as upfront oral pharmacotherapy options with NMB $92,135.18. In an alternative 10-year time horizon scenario, FT price per injection at $11,000 and $4,500 makes FT as cost-effective as oral pharmacotherapies. One-way sensitivity analysis showed this result is most sensitive to upfront therapy prices, FT efficacy and initial IPSS. At price per injections of $5,000, $10,000 and $15,000, the probability that FT is either cost-effective or dominant compared to upfront oral pharmacotherapy options using a WTP threshold of $150,000 per QALY is 100%, 93% and 40%, respectively.

Conclusions:

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.

01 Jun 2022·Aktuelle UrologieQ4 · MEDICINE

Q4 · MEDICINE

Article

Author: Miernik, Arkadiusz ; Franz, Julia ; Gratzke, Christian

01 Jan 2021·Investigative and clinical urologyQ4 · MEDICINE

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

Q4 · MEDICINE

ReviewOA

Author: Ng, Brian Hung Shin ; Chung, Eric

There is a strong association between benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) and sexual dysfunction. While transurethral resection of the prostate (TURP) is considered the standard BPH treatment, it is however associated with a high rate of erectile and ejaculatory dysfunctions. Over the past decade, new and novel minimally invasive BPH therapies have been shown to improve various parameters of voiding domains while minimizing adverse sexual effects. 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.

News (Medical) associated with Fexapotide triflutate(Nymox Pharmaceutical Corp.)

30 Aug 2024

·www.globenewswire.com

Nymox Announces Filing of Annual Report

IRVINE, Calif., Aug. 30, 2024 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) is pleased to report that it filed its Annual Report with the Security and Exchange Commission (SEC) on August 29, 2024. About NYMOX Nymox is in the process of submitting, and has submitted applications for the approval to market the Company's first in class drug NYMOZARFEX™ to treat the symptoms of benign prostatic hyperplasia (BPH). BPH is one of the most common conditions affecting middle aged and elderly men throughout the world. BPH can be devastating to men who suffer from the condition. Current treatments are associated with numerous intolerable side effects including sexual problems, such as impotence and retrograde ejaculation. Medications for BPH have been associated with prostate cancer, depression, gynecomastia and other adverse effects. The majority of men stop taking the available medications due to these and other problems. Surgery is often needed for advanced BPH. Surgery is usually effective but it is not without risks, the discomforts of surgery, and BPH surgery has side effects such as permanent retrograde ejaculation for many patients. Nymox recently reported 10-year follow-up new data on all available patients from its U.S. clinical trial of NYMOZARFEX™ for the treatment of low grade localized prostate cancer. The available long-term data newly assessed, confirmed that all available data shows that the NYMOZARFEX™ treatment had important and statistically significant benefit for reducing the long-term progression of these prostate cancers. About NYMOZARFEX (TM) (Fexapotide) NYMOZARFEX (TM) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 patients with over 1600 injections administered including over 1200 NYMOZARFEX™ administrations. NYMOZARFEX™ has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments. For more information please contact info@nymox.com or 800-936-9669. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of NYMOZARFEX™ to treat BPH and prostate cancer and the estimated timing of further developments for NYMOZARFEX™. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, and performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on NYMOZARFEX™, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of NYMOZARFEX™. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2023, and its Quarterly Reports. For Further Information Contact:Nymox Pharmaceutical Corporation1-800-93NYMOXwww.nymox.com

18 Jul 2024

·www.globenewswire.com

Nymox Annual Report

IRVINE, Calif., July 18, 2024 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) announced today that its Annual Report is and has been in progress since late February, soon after Nymox received some of its corporate documents withheld by the terminated officers and directors. Unfortunately, this has caused delays beyond the Company’s control in its completion. The Company believes that the audit will be completed soon, and it will issue its annual report as soon as possible thereafter. About NYMOX Nymox is in the process of submitting, and has submitted applications for the approval to market the Company's first in class drug NYMOZARFEX™ to treat the symptoms of benign prostatic hyperplasia (BPH). BPH is one of the most common conditions affecting middle aged and elderly men throughout the world. BPH can be devastating to men who suffer from the condition. Current treatments are associated with numerous intolerable side effects including sexual problems, such as impotence and retrograde ejaculation. Medications for BPH have been associated with prostate cancer, depression, gynecomastia and other adverse effects. The majority of men stop taking the available medications due to these and other problems. Surgery is often needed for advanced BPH. Surgery is usually effective but it is not without risks, the discomforts of surgery, and BPH surgery has side effects such as permanent retrograde ejaculation for many patients. Nymox recently reported 10-year follow-up new data on all available patients from its U.S. clinical trial of NYMOZARFEX™ for the treatment of low grade localized prostate cancer. The available long-term data newly assessed, confirmed that all available data shows that the NYMOZARFEX™ treatment had important and statistically significant benefit for reducing the long-term progression of these prostate cancers. About NYMOZARFEX (TM) (Fexapotide) NYMOZARFEX (TM) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 patients with over 1600 injections administered including over 1200 NYMOZARFEX™ administrations. NYMOZARFEX™ has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments. For more information please contact info@nymox.com or 800-936-9669. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of NYMOZARFEX™ to treat BPH and prostate cancer and the estimated timing of further developments for NYMOZARFEX™. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on NYMOZARFEX™, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of NYMOZARFEX™. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2022, and its Quarterly Reports.

16 Jul 2024

·www.globenewswire.com

Nymox Required to Resubmit Application to DKMA

IRVINE, Calif., July 16, 2024 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (“Nymox”) (OTC Markets NYMXF) announced today that its MAA submission to the Danish Medicines Agency (DKMA) has run out of time and in order to continue will be required to extend the MAA application to DKMA by re-submission with a new fee required. As it currently stands the application “does not meet the conditions of the Medicines Act for issuing a marketing authorization.” Although a great number of questions were resolved by the Company, there remain further responses required that will require additional cycle time. The Company is busy analyzing the approaches that are possible. Nymox cannot guarantee that all questions can be resolved. The Company believes that it has the data required to formulate the required re-submission. For example: DKMA required Nymox to develop an assay and method to ensure impurities of Nymozarfex™ are below 0.1%, which was slightly lower than the submission percentage of 0.2%. Nymox collaborators have subsequently succeeded to develop the requisite method, but it took more time than DKMA permitted. DKMA stated: “Once the updated. . .method for ID, assay and related substances with acceptable LOQ of at least 0.1% is available it is expected that all related information in the dossier will be updated as confirmed. . .”;DKMA required Nymox to provide evidence that the long term follow up (LTFU) studies were double blinded, and Nymox provided a solid report from an independent audit confirming all LTFU studies were double blinded. DKMA then required additional information to augment the audit certificates already issued by the independent arm’s length audit which confirmed the double blind. Nymox has this information but there was insufficient time left to provide the submission required;The Nymozarfex data analysis was found to be robust, but DKMA had remaining major unresolved questions. The Company believes that it has solid answers to all remaining questions, but additional submission cycles are required; andThere were no significant human clinical trial major safety issues for Nymozarfex. The Company's MAA to MHRA in the U.K. is in the active process of responses to questions received from MHRA. Nymox will update later in the cycle when appropriate. About NYMOX Nymox is in the process of submitting applications for the approval to market the Company's first in class drug NYMOZARFEX™ to treat the symptoms of benign prostatic hyperplasia (BPH). BPH is one of the most common conditions affecting middle aged and elderly men throughout the world. BPH can be devastating to men who suffer from the condition. Current treatments are associated with numerous intolerable side effects including sexual problems, such as impotence and retrograde ejaculation. Medications for BPH have been associated with prostate cancer, depression, gynecomastia and other adverse effects. The majority of men stop taking the available medications due to these and other problems. Surgery is often needed for advanced BPH. Surgery is usually effective but it is not without risks, the discomforts of surgery, and BPH surgery has side effects such as permanent retrograde ejaculation for many patients. Nymox recently reported 10-year follow-up new data on all available patients from its U.S. clinical trial of NYMOZARFEX™ for the treatment of low grade localized prostate cancer. The available long-term data newly assessed, confirmed that all available data shows that the NYMOZARFEX™ treatment had important and statistically significant benefit for reducing the long-term progression of these prostate cancers. About NYMOZARFEX (TM) (Fexapotide) NYMOZARFEX (TM) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 patients with over 1600 injections administered including over 1200 NYMOZARFEX™ administrations. NYMOZARFEX™ has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments. For more information please contact info@nymox.com or 800-936-9669. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of NYMOZARFEX™ to treat BPH and prostate cancer and the estimated timing of further developments for NYMOZARFEX™. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on NYMOZARFEX™, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of NYMOZARFEX™. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2022, and its Quarterly Reports. For Further Information Contact:Nymox Pharmaceutical Corporation 1-800-93NYMOXwww.nymox.com

100 Deals associated with Fexapotide triflutate(Nymox Pharmaceutical Corp.)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Hyperplasia	NDA/BLA	DK	Nymox Pharmaceutical Corp.	21 Mar 2023
Lower Urinary Tract Symptoms	Phase 3	US	Nymox Pharmaceutical Corp.	01 Apr 2013
Localized Prostate Carcinoma	Phase 2	US	Nymox Pharmaceutical Corp.	21 Feb 2012
Prostatic Cancer	Phase 2	-	Recordati SpA	-
Liver Cancer	Preclinical	US	Nymox Pharmaceutical Corp.	28 Feb 2018

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