NYMX Nymox Pharmaceutical Corporation

2.46
-0.14  -5%
Previous Close 2.6
Open 2.57
52 Week Low 1.66
52 Week High 4.79
Market Cap $187,838,591
Shares 76,357,151
Float 43,777,012
Enterprise Value $180,356,447
Volume 123,166
Av. Daily Volume 154,826
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Drug Stage Catalyst Date
NX-1207 Fexapotide
BPH
NDA Filing
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Drug Pipeline

Drug Stage Notes
NX-1207 long-term NX03-0040 trial
Low grade localized prostate cancer
Phase 2
Phase 2
Data released February 2016 met endpoint

Latest News

  1. HASBROUCK HEIGHTS, N.J., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) today announced it has entered into definitive agreements with institutional and accredited investors for the purchase and sale of shares of its common stock at a purchase price of $2.50 per share in a registered direct offering for gross proceeds of approximately $9 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about August 14, 2020, subject to the satisfaction of customary closing conditions.

    Nymox intends to use the proceeds for general corporate purposes, including working capital.

    A.G.P./Alliance Global Partners is acting as sole placement agent for the offering…

    HASBROUCK HEIGHTS, N.J., Aug. 12, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) today announced it has entered into definitive agreements with institutional and accredited investors for the purchase and sale of shares of its common stock at a purchase price of $2.50 per share in a registered direct offering for gross proceeds of approximately $9 million before deducting placement agent fees and expenses. The closing of the offering is expected to occur on or about August 14, 2020, subject to the satisfaction of customary closing conditions.

    Nymox intends to use the proceeds for general corporate purposes, including working capital.

    A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

    This offering is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-237564) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at . Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Nymox has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Nymox and such offering.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Nymox Pharmaceutical Corporation

    Nymox Pharmaceutical Corporation specializes in the research and development of therapeutics and diagnostics, with a particular emphasis on products targeted for the unmet needs of the rapidly aging male population in developed economies. The Company's lead drug candidate for benign prostatic hyperplasia (BPH) Fexapotide Triflutate (FT) has completed Phase 3 development in more than 70 clinical centers in the United States, involving more than 1700 patients during the entire clinical development program. Currently, the Company will soon be filing for approval in major economies around the world, including the United States and Europe.

    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 Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. 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 Fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. 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, 2019, and its Quarterly Reports.

    For Further Information Contact:

    Erik Danielsen                                                                                                       

    Nymox Pharmaceutical Corporation

    1-800-93NYMOX

    www.nymox.com

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  2. HASBROUCK HEIGHTS, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to report current updates on the Company's most important ongoing developments. The Company reports further significant and important progress has been made with remaining items for the upcoming regulatory filings in 2020 for the Company's first in class innovative prostate drug Fexapotide Triflutate (FT). The Company has moved swiftly ahead on its regulatory marketing applications by remote work with a strong team of expert collaborators, even with the occasional difficulties from the Covid situation leading to restricted or delayed access to certain required sources and to sites included in the Company's studies.

    Nymox is…

    HASBROUCK HEIGHTS, N.J., July 28, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to report current updates on the Company's most important ongoing developments. The Company reports further significant and important progress has been made with remaining items for the upcoming regulatory filings in 2020 for the Company's first in class innovative prostate drug Fexapotide Triflutate (FT). The Company has moved swiftly ahead on its regulatory marketing applications by remote work with a strong team of expert collaborators, even with the occasional difficulties from the Covid situation leading to restricted or delayed access to certain required sources and to sites included in the Company's studies.

    Nymox is also pleased to announce that it has recently formally filed with the regulatory authorities for new trademark brand names for FT in different jurisdictions including US and Europe. The Company will report further on these regulatory filings as they proceed.

    Nymox also announces that since its last communication, several FT-related patents have been newly granted based on applications filed in the recent past. FT has very strong global patent protection which translates into exclusivity rights in the major global markets.

    The Company will continue to provide regular updates on the progress in its regulatory filings which are expected in the near-term horizon.

    Fexapotide (FT) has been designed and targeted for middle aged and elderly men throughout the world, who as they get older, develop enlarged prostate glands (BPH). Men with BPH often have progressive difficulties with urination and related symptoms that have serious impact upon their lives, causing discomfort, restricting activities, disrupting sleep, and leading to serious complications. With advancing age, a majority of men will have some degree of prostate enlargement, often with the resulting distressing urinary tract symptoms. Many men end up needing invasive surgery which can have long-term side effects such as permanent retrograde ejaculation and other risks.

    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, Myrtle Beach, SC; Ronald Tutrone, Baltimore, MD; Mitchell Efros, Garden City, NY; Mohamed Bidair, San Diego, CA; Barton Wachs, Long Beach, CA; Susan Kalota, Tucson, AZ; Sheldon Freedman, Las Vegas, NV; James Bailen, Louisville, KY; Richard Levin, Towson, MD; Stephen Richardson, Salt Lake City, UT; Jed Kaminetsky, New York, NY; Jeffrey Snyder, Denver, CO; Barry Shepard, Garden City, NY; Kenneth Goldberg, Lewisville, TX); Alan Hay, Salem, OR; Steven Gange, Salt Lake City, UT; Ivan Grunberger, Brooklyn, NY (https ://doi.org/10.1007/s0034 5-018-2185-y)) and Therapeutic Advances in Urology 2019, Vol. 11: 1–16  (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, Ronald Tutrone and Claus  G. Roehrborn  (https://journals.sagepub.com/doi/10.1177/1756287218820807)). Scientific studies were published recently in the highly regarded Research and Reports in Urology (2019 11:343-350) (https://doi.org/10.2147/RRU.S231334). 

    FT has also shown effectiveness in slowing the progression of low grade early prostate cancer. 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, Myrtle Beach, SC; Steven A. Kaplan, New York, NY; Ronald Tutrone, Baltimore, MD; Richard Levin, Towson, MD; James Bailen, Louisville, KY; Alan Hay, Salem, OR; Susan Kalota, Tucson, AZ; Mohamed Bidair, San Diego, CA; Sheldon Freedman, Las Vegas, NV; Kenneth Goldberg, Lewisville, TX; Frederick Snoy, Albuquerque, NM; Jonathan I. Epstein, Baltimore, MD. The FT prostate cancer article is available online at https://doi.org/10.1007/s00345-020-03127-w.    

    The FT prostate cancer study enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites. Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years.  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). Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg). Safety data showed no serious adverse events related to FT during the study.

    For more information please contact 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 Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. 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 Fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. 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, 2019, and its Quarterly Reports.

    For Further Information Contact:

    Erik Danielsen

    Nymox Pharmaceutical Corporation

    1-800-93NYMOX

    www.nymox.com

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  3. HASBROUCK HEIGHTS, N.J., June 19, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is very pleased to report that key steps in its regulatory submission preparations have been completed and the project is firmly on-track. The majority of its regulatory documentation has proceeded very well, despite the inherent limitations of the business environment in 2020. Certain tasks have been hampered by the Covid pandemic restrictions, similar to other companies in the sector. These remaining tasks are expected to be completed reasonably soon as the Company regains the ability to retrieve required documentation from external sites and to complete other required tasks and on-site activities that were hindered due to the global…

    HASBROUCK HEIGHTS, N.J., June 19, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is very pleased to report that key steps in its regulatory submission preparations have been completed and the project is firmly on-track. The majority of its regulatory documentation has proceeded very well, despite the inherent limitations of the business environment in 2020. Certain tasks have been hampered by the Covid pandemic restrictions, similar to other companies in the sector. These remaining tasks are expected to be completed reasonably soon as the Company regains the ability to retrieve required documentation from external sites and to complete other required tasks and on-site activities that were hindered due to the global restrictions in place.

    Dr. Paul Averback, CEO commented "We are extremely pleased with the progress we have been able to achieve despite these obvious limitations due to the pandemic restrictions as we reported in our 6K filing on April 24. I want to thank the whole team for putting in an extraordinary effort towards meeting our regulatory timeline goals. Extremely complex tasks have been coordinated and executed successfully. Given the ongoing reopening of the economy we now expect to attend to the remaining matters near-term. Taking into account the above factors, we are well within our projected timelines as corrected for by the addition of the previously announced Covid-related delay of several months. We are now expecting to file our applications with the authorities approximately by the end of Q3 or early Q4. We will continue to regularly update our shareholders as we complete the entire packages."

    "Nymox management is very proud of the quality of our evidence and we not only look forward to the upcoming near-term submissions, but we are highly enthusiastic about the prospects for our Company and its shareholders. This is a field which has a substantial unmet medical need for safer and more effective treatments. The Company has achieved numerous major successes in the past couple years with its intellectual property applications around the world which have greatly extended the timeline value of the Company's Fexapotide treatments for prostate enlargement and for prostate cancer", Dr. Averback said.  

    For further in-depth detailed information about the Nymox treatments for prostate enlargement (BPH) and early stage prostate cancer please see peer review publications at the following links: https://doi.org/10.1007/s00345-018-2185-y and https://link.springer.com/article/10.1007/s00345-020-03127-w and visit www.nymox.com.

    For more information please contact 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 Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. 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 Fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. 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, 2019, and its Quarterly Reports.

    For Further Information Contact:

    Erik Danielsen                                                                                                       

    Nymox Pharmaceutical Corporation

    1-800-93NYMOX

    www.nymox.com 

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  4. HASBROUCK HEIGHTS, N.J., April 21, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce the recent allowances of 4 new different US and international patents concerning the Company's prostate enlargement and prostate cancer treatments. The new US and international patents that have been allowed are further expansions of Nymox's intellectual property covering the Company's prostate treatment technologies.

    Nymox CEO, Dr Paul Averback stated, "Intellectual property is one of the backbones of the biopharmaceutical industry. We are therefore very pleased to report that another 4 patents have recently been allowed. During the past year a total of 10 new patents have been allowed which adds to the Company's…

    HASBROUCK HEIGHTS, N.J., April 21, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce the recent allowances of 4 new different US and international patents concerning the Company's prostate enlargement and prostate cancer treatments. The new US and international patents that have been allowed are further expansions of Nymox's intellectual property covering the Company's prostate treatment technologies.

    Nymox CEO, Dr Paul Averback stated, "Intellectual property is one of the backbones of the biopharmaceutical industry. We are therefore very pleased to report that another 4 patents have recently been allowed. During the past year a total of 10 new patents have been allowed which adds to the Company's very strong intellectual property position for the future. Nymox continues with intensive work to maximize our IP portfolio for the long-term value and strength of the Company's proprietary foundations."

    Dr. Averback added, "Operationally at the present time, our employees are doing very well and are following the prescribed guidelines in their area, including working remotely, where necessary. On a different note, we are also extremely pleased with the reactions and feedback we are receiving from multiple sources with regard to the recent (Feb 2020) peer review journal article in the World Journal of Urology (https://link.springer.com/article/10.1007/s00345-020-03127-w) documenting the very promising clinical results of Fexapotide Triflutate in treating men with early prostate cancer. We look forward to advancing this program into pivotal registrational trials."

    The recent peer review publication is entitled "Prospective Evaluation of Fexapotide Triflutate Injection Treatment of Grade Group 1 Prostate Cancer: Four Year Results". The authors are Neal Shore, Myrtle Beach, SC; Steven A. Kaplan, New York, NY; Ronald Tutrone, Baltimore, MD; Richard Levin, Towson, MD; James Bailen, Louisville, KY; Alan Hay, Salem, OR; Susan Kalota, Tucson, AZ; Mohamed Bidair, San Diego, CA; Sheldon Freedman, Las Vegas, NV; Kenneth Goldberg, Lewisville, TX; Frederick Snoy, Albuquerque, NM; Jonathan I. Epstein, Baltimore, MD.

    The Fexapotide (FT) prostate cancer study was started in 2012 and enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites. Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years. Patients randomized to FT were treated with a single one-time targeted injection of FT, either 2.5mg or 15mg. Statistical comparisons were made over time of the proportions of subjects and untreated controls who progressed to higher Gleason grade and/or invasive treatments instituted with prostatectomy, radiotherapy, or chemotherapy. 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).
    • FT treatment group had reduced (-54.7%) 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).
    • Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg). Safety data showed no serious adverse events related to FT during the study.

    FT is a pro-apoptotic proprietary drug which promotes natural programmed cell death (apoptosis) in prostatic glandular cells which compose the prostate cancer. FT has been safely administered to men in clinical trials in the U.S. involving over 1700 patients and controls treated for BPH or prostate cancer. FT has completed Phase 3 studies for BPH and further studies of FT for prostate cancer are planned in the near future.

    For more information please contact 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 Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. 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 Fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. 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, 2019, and its Quarterly Reports.

    For Further Information Contact:
    Erik Danielsen
    Nymox Pharmaceutical Corporation
    1-800-93NYMOX
    www.nymox.com

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  5. HASBROUCK HEIGHTS, N.J., Feb. 24, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) 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.

    This report represents the first publication in the medical literature of multi-year long-term data from a well-powered prospective randomized multi-center clinical trial for a prostate injectable treatment in men targeted to low grade early prostate cancer and showing statistically significant efficacy for a locally targeted molecular injectable treatment.

    The new publication is entitled "Prospective Evaluation…

    HASBROUCK HEIGHTS, N.J., Feb. 24, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) 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.

    This report represents the first publication in the medical literature of multi-year long-term data from a well-powered prospective randomized multi-center clinical trial for a prostate injectable treatment in men targeted to low grade early prostate cancer and showing statistically significant efficacy for a locally targeted molecular injectable treatment.

    The new publication is entitled "Prospective Evaluation of Fexapotide Triflutate Injection ‎Treatment of Grade Group 1 Prostate Cancer: Four Year Results". The authors are Neal Shore, Myrtle Beach, SC; Steven A. Kaplan, New York, NY; Ronald Tutrone, Baltimore, MD; Richard Levin, Towson, MD; James Bailen, Louisville, KY; Alan Hay, Salem, OR; Susan Kalota, Tucson, AZ; Mohamed Bidair, San Diego, CA; Sheldon Freedman, Las Vegas, NV; Kenneth Goldberg, Lewisville, TX; Frederick Snoy, Albuquerque, NM; Jonathan I. Epstein, Baltimore, MD. The article is available online at https://link.springer.com/article/10.1007/s00345-020-03127-w.     

    The Fexapotide (FT) study was started in 2012 and enrolled 147 men with localized Gleason Grade 6 T1c prostate cancer at 28 U.S. clinical investigation sites. Patients were followed with clinical and laboratory evaluations and regular periodic prostate biopsies for up to 5 years. Patients randomized to FT were treated with a single one-time targeted injection of FT, either 2.5mg or 15mg. Statistical comparisons were made over time of the proportions of subjects and untreated controls who progressed to higher Gleason grade and/or invasive treatments instituted with prostatectomy, radiotherapy, or chemotherapy. 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). Results for the high dose (FT 15mg) were superior to the lower dose (FT 2.5mg). Safety data showed no serious adverse events related to FT during the study.

    The current recommended standard of care for these patients is active surveillance: patients are monitored carefully over time to determine if and when the cancer becomes more advanced and thus will require more aggressive treatment, like radiation therapy or surgery.

    Dr. Neal Shore, lead author of the report, said "The study results demonstrate data in a large multi-center clinical trial of men treated with transrectal ultrasound guided FT for early stage, low risk prostate cancers, which suggest an effective result for reducing histopathologic progression, as evidenced by repeated biopsies over time, while also demonstrating a favorable safety profile. This study presents long-term FT data which supports its efficacy for avoidance of biologic progression in an active surveillance prostate cancer population. A therapy to optimize the success of an active surveillance strategy is a welcomed advance for these patients."

    Dr Steven Kaplan, Professor of Urology and Director of the Benign Urologic Diseases and The Men's Health Program at Icahn School of Medicine at Mount Sinai, New York, and a co-author of the report said, "This study reports the long-term data from a prospective study of an injectable for localized Grade Group 1 prostate cancer -- which is the first time this has been accomplished for a very common problem in men. Regulatory approval of Fexapotide Triflutate (FT) will be a very important treatment adjunct for countless men with this problem."

    The FT treatments were administered in a urology office setting without anesthesia or sedation, consisting of a single relatively painless transrectal injection into the area of the prostate cancer. The percentage of patients with surgery or radiotherapy with Gleason grade progression was reduced by 73.3% in patients treated with a single injection of FT 15mg and by 62.6% in pooled (high and low dose FT groups combined) FT patients compared to controls.

    Dr. Jonathan Epstein a co-author and researcher involved in the study, stated "Although more and more men are electing active surveillance for low grade prostate cancer, approximately 25-35% will show increased grade on follow-up biopsy which typically leads to definitive therapy. In this study, Fexapotide Triflutate decreased the risk of upgrading on follow-up biopsy enabling men to stay on active surveillance. Even if Fexapotide Triflutate enables men to stay on active surveillance longer before they eventually experience upgrading, there would be a significant benefit for men to delay the onset of side effects associated with therapy and in the interim enjoy a better quality of life. Future studies are needed to expand the criteria for study of Fexapotide Triflutate to include men with large volume Grade Group 1 disease and possibly men with low volume, low percent pattern 4 Grade Group 2 cancer. Identifying the ideal candidates for Fexapotide Triflutate also factoring in multiparametric MRI findings remains to be determined."

    FT is a pro-apoptotic proprietary drug which promotes natural programmed cell death (apoptosis) in prostatic glandular cells which compose the prostate cancer. FT has been safely administered to men in clinical trials in the U.S. involving over 1700 patients and controls treated for BPH or prostate cancer. FT has completed Phase 3 studies for BPH and further studies of FT for prostate cancer are planned in the near future.

    For further detailed information about the published study please refer to the new report online at the World Journal of Urology.

    For more information please contact  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 Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. 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 Fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. 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, 2018, and its Quarterly Reports.

    For Further Information Contact:
    Erik Danielsen
    Nymox Pharmaceutical Corporation
    1-800-93NYMOX
    www.nymox.com

     

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