Fexapotide for BPH

Fexapotide Triflutate is a protein injectable for benign prostatic hyperplasia (prostate enlargement, "BPH") and for low grade localized prostate cancer. It has been designed to be administered in the urologist's office in a simple injection that takes a few minutes. FT is a new molecular entity which safely targets prostate glandular cells that have proliferated in BPH. FT works by a mechanism of inducing apoptosis (programmed cell death) which selectively removes cells in the enlarged BPH prostate gland, and that also is useful in removing low grade localized early stage prostate cancers.

In research studies, FT is associated with increased expression of important apoptosis markers, and all of the cellular signs of the hallmarks of apoptotic cell loss. FT has remarkable selectivity for the overgrowth of the prostate gland cells in BPH and in low grade localized prostate cancer. Studies of FT's cellular effects, metabolism and kinetics have shown that FT does not have any effects on nearby structures or on important distant organs. Repeated injections of FT do not induce any discernible immune reaction in patients, which is another important reason for FT's excellent safety results. In large clinical trials involving over 1700 men there have been minimal side effects from FT.

Clinical trials of Fexapotide Triflutate for BPH

Long-term studies of FT involving 997 enrolled patients followed for up to 7 years showed statistically significant lasting improvement in BPH symptom scores compared to placebo controls. The symptom scores reflect improvements in urgency, frequency, nocturia, poor urinary flow, stopping and starting, incomplete emptying, and straining. Long-term studies also showed that patients who received 1 or 2 injections of FT had significantly less need for invasive BPH surgical interventions than control patients who did not receive FT. The clinical trials also demonstrated improvements in sexual function in patients given FT. FT treatment led to lower incidence of the need for bladder catheterization, and none of the typical side effects associated with current drug treatments.

The full clinical trial results are available in the peer review publication "Fexapotide triflutate: results of long-term safety and efficacy trials of a novel injectable therapy for symptomatic prostate enlargement" published in World Journal of Urology Volume 36, Issue 5, pages 801-809, May 2018, and authored by Neal Shore, Ronald Tutrone, Mitchell Efros, Mohamed Bidair, Barton Wachs, Susan Kalota, Sheldon Freedman, James Bailen, Richard Levin, Stephen Richardson, Jed Kaminetsky, Jeffrey Snyder, Barry Shepard, Kenneth Goldberg, Alan Hay, Steven Gange, and Ivan Grunberger.

Recently, a new peer review journal publication reviewing FT clinical results has been published, 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). The new peer review article is available on the website of the journal.

FT Mechanism of Action

FT works by a mechanism of inducing apoptosis (programmed cell death) which selectively removes cells in the enlarged BPH prostate gland, and that also is useful in removing low grade localized early stage prostate cancers. In research studies, FT is associated with increased expression of important apoptosis markers, and all of the cellular signs of the hallmarks of apoptotic cell loss. In large clinical trials involving over 1700 men there have been minimal side effects from FT, which is based on FT's remarkable selectivity for the overgrowth of the prostate gland cells in BPH and in low grade localized prostate cancer. Studies of FT's cellular effects, metabolism and kinetics have shown that FT does not have any effects on nearby structures or on important distant organs. Repeated injections of FT do not induce any discernible immune reaction in patients which is another important reason for FT's excellent safety results.

Forward Looking Statements

To the extent that statements contained herein 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, 2016, and its Quarterly Reports.