Nymox Announces New Peer Review Article on Fexapotide Pharmaco-Ablation Experimental Studies Published in Research and Reports in Urology

HASBROUCK HEIGHTS, N.J., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation NYMX is pleased to report a new peer review research report has been published on experimental studies of the Company's Fexapotide Triflutate treatment for prostate enlargement (BPH) and low grade prostate cancer. The article is entitled "Fexapotide triflutate induces selective prostate glandular pharmaco-ablation in the rat" and it is published in Research and Reports in Urology.

The research report presents data and scientific evidence for how Fexapotide inhibits prostate enlargement by selectively eliminating prostate glandular cells while preserving key elements including nerves, blood vessels, and adjacent structures. This exquisitely selective ablation mechanism is one of several main reasons that Fexapotide has achieved its excellent safety profile in human trials involving over 1700 injections of Fexapotide and controls. Research and Reports in Urology is a very highly respected international peer review journal of urological research. The full peer review article is available online at https://doi.org/10.2147/RRU.S231334. 

According to the article, "These studies in the rat have shown that FT intraprostatic administration consistently leads to significant and selective prostate glandular epithelial apoptotic cell loss and gland shrinkage, with the absence of discernible damage to adjacent and surrounding tissues including nerves, blood vessels and other important structures. Gland-specific targeted molecular ablation of overgrown prostatic glands in the transition zone in the prostate with nerve sparing is a novel mechanism of action for a prostate therapeutic which has important benefits. The nerve and stromal sparing for peri-prostatic tissues provides an objective underlying basis for the observed safety of FT treatment in human BPH studies."

The report concludes, "A major challenge for prostate treatments has been to produce or promote beneficial targeted gland destruction that is structurally selective at the microscopic tissue level in order to avoid undesirable toxicities and irreparable damage to important adjacent structures. Fexapotide triflutate (FT) has been shown in human clinical trials to be a well-tolerated pharmaco-ablative agent with therapeutic benefit in patients with prostate enlargement and low-grade prostate cancer. Evidence from experimental animal studies shows that FT leads to prostate glandular cell loss not found in controls, by apoptosis that is highly selective with sparing of nerves, vascular elements and stroma, and near-total loss of glandular epithelium at 12 months."

The new report was authored by Paul Averback, MD; Rajna Gohal, M.Sc, Marta Fuska, Kathleen Prins, and Ping Wang, MD.

Nymox's lead drug Fexapotide (FT) has been in development for over 10 years and has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, and has been found after 7 years of prospective placebo controlled double blind studies of treatment of 977 U.S. men with prostate enlargement to not only show clinically meaningful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of prostate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. FT has been shown to produce long-term improvements in lower urinary tract symptoms associated with prostate enlargement (BPH), a problem that afflicts an estimated 100 million or more men in the world. FT does not cause the annoying side effects and risks found with available treatments for BPH. FT is also in development for low grade prostate cancer.

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 (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); and Claus G. Roehrborn, MD (University of Texas Southwestern Medical Center, Dallas, TX) was published in Therapeutic Advances in Urology. 2019;11:1-16.

The clinical trial results for Fexapotide treatment of BPH are published in the World Journal of Urology May 2018, Volume 36, pages 801–809 (https://doi.org/10.1007/s00345-018-2185-y) in a peer review report entitled "Fexapotide Triflutate: Results of Long- Term Safety and Efficacy Trials of a Novel Injectable Therapy for Symptomatic Prostate Enlargement" authored by Neal Shore, MD, FACS (Carolina Urologic Research Center, Myrtle Beach, SC); Ronald Tutrone, MD, FACS (Chesapeake Urology Research Associates, Baltimore, MD); Mitchell Efros, MD, FACS (Accumed Research, Garden City, NY); Mohamed Bidair, MD (San Diego Clinical Trials, San Diego, CA); Barton Wachs, MD (Atlantic Urology Medical Group, Long Beach, CA); Susan Kalota, MD (Urological Associates of Southern Arizona, Tucson, AZ); Sheldon Freedman, MD, FACS (Freedman Urology, Las Vegas, NV); James Bailen, MD, FACS (First Urology, Louisville, KY); Richard Levin, MD, FACS (Chesapeake Urology Research Associates, Towson, MD); Stephen Richardson, MD (Jean Brown Research, Salt Lake City, UT); Jed Kaminetsky, MD, FACS (University Urology, New York, NY); Jeffrey Snyder, MD, FACS (Genitourinary Surgical Consultants, Denver, CO); Barry Shepard, MD, FACS (Urological Surgeons of Long Island, Garden City, NY); Kenneth Goldberg, MD, FACS (U T Southwestern Dept of Urology, Lewisville, TX); Alan Hay, MD, FACS (Willamette Urology, Salem, OR); Steven Gange, MD, FACS (Summit Urology Group, Salt Lake City, UT); Ivan Grunberger, MD, FACS (Brooklyn Urology, Brooklyn, NY).

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 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