On January 6, 2020 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is reported 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 (Press release, Nymox, JAN 6, 2020, View Source [SID1234552728]). 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.
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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 View Source
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 (View Source) 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).