Nymox Pharmaceutical Corporation reported today that after long-term safety assessments of repeated Fexapotide Triflutate (FT) intraprostatic injections, there have been no identifiable risks or serious side effects or adverse events identified associated or linked with the drug.
HASBROUCK HEIGHTS, N.J., Oct. 03, 2018 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported today that after long-term safety assessments of repeated Fexapotide Triflutate (FT) intraprostatic injections, there have been no identifiable risks or serious side effects or adverse events identified associated or linked with the drug.
FT is Nymox’s lead drug for which the Company is in the process of seeking U.S. and European marketing approvals for BPH (prostate enlargement), and FT is also in late stage development for prostate cancer. Pivotal trial results for FT BPH studies involving 977 treated patients were published in 2018 in the prestigious World Journal of Urology (May 2018, Volume 36, pages 801–809), and the safety and efficacy results have been presented to the American Urology Association and previously to the European Association of Urology.
Dr. Paul Averback, CEO of Nymox said, “For prostate cancer in particular, repeated injection treatments will be needed and a focal molecular treatment will have negligible value if there cannot be reliable safety expected from repeated injection. Prostate cancer is a multi-focal disease and it is to be expected that multiple focal molecular treatments will be utilized for optimal outcomes. Follow-up and re-treatment will be needed. Nymox undertook 2 large FT re-injection safety studies in 2010-2014 involving 351 subjects with BPH, who were subsequently followed for up to 7 years. These mandatory and adequately sized safety studies are absolutely required in order to demonstrate safety of re-injection, and this is a standard requirement.”
Dr Averback added, “In addition, Nymox undertook extensive immunological testing involving over 1000 subject samples, demonstrating that FT does not lead to detectable antibody formation, which underlines FT safety and supports the lack of risk for allergic reactions. All laboratory testing and sexual function tests including semen analyses showed no changes in FT treated men compared to controls.”
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. The same clinical program has also shown in a long-term blinded placebo group study an 82-95% reduction in the number of these patients who required surgery after they received FT in the trial, as compared to patients who did not receive FT but instead later received conventional approved BPH treatments (p<.0001).
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.
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, 2017, and its Quarterly Reports.
For Further Information Contact:
Erik Danielsen
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
