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.
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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.
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