Nymox (NYMX) Issues Positive Results from LT Prostate Enlargement Study

August 29, 2016 10:31 AM EDT

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Nymox Pharmaceutical Corporation (Nasdaq: NYMX) lead drug fexapotide which has been in development for over a decade and which has been tested by expert clinical trial investigative teams in over 70 distinguished clinical trial centers throughout the US, has been found after 7 years of prospective placebo controlled double blind studies of treatment of 995 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. This is in stark contrast to some conventional BPH treatments in routine clinical use today which on the other hand increase prostate cancer risk, and which have many other well-known undesirable side effects such as retrograde ejaculation which is when men lose the ability to have normal orgasms.

The same clinical program conducted at the same highly regarded treatment centers under rigorous trial scrutiny and performed strictly at arms-length by top teams of clinical investigators across the country, has now also shown that the long-term blinded placebo crossover group study has resulted in an 82-95% reduction in the number of these patients who required surgery after they received crossover fexapotide in the trial, as compared to patients who did not receive fexapotide but instead received crossover conventional approved BPH treatments (p<.0001). The aim of the crossover study was to determine the clinical benefit fexapotide can provide to men who initially were double blind randomized to and received placebo, remained blinded as to their placebo treatment, and who subsequently required additional medical and/or surgical treatment. In this study long-term outcomes were determined in 391 patients who were given double blind placebo injections, which were followed by crossover to other treatments at the patients' discretion. The numbers of blinded placebo patients who subsequently received surgical treatment during the next 2-3 years for their BPH symptoms were then prospectively analyzed.

For the long-term cancer incidence analysis, the men in the study received fexapotide or placebo for the treatment of their prostate enlargement (BPH) symptoms. All men were thoroughly evaluated at expert urological testing investigational centers to exclude any prostate cancer prior to qualifying for enrollment in the studies. The participants were enrolled at these over 70 top well-known U.S. urological investigational centers, and were followed for up to 7 years (median of 5 years) after treatment. The study analyzed all cases of prostate cancer that were subsequently diagnosed. The expected rate of new prostate cancer in the U.S. general male population in this age group is in the 5-20% range after 7 years. In the BPH population in published large trials of drugs for the prevention of prostate cancer, the incidence of new prostate cancer cases after 4-7 years has been reported in major studies to be 20-25%. The new data analysis from the Nymox fexapotide study has now shown the statistically significant and very low incidence of 1.3% for prostate cancer in this comparable fexapotide treated BPH population. By comparison, for example in a population of patients with erectile dysfunction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5% (and 22.7% in controls) as recently reported in a large U.S. study published in the Journal of Urology (Volume 196; 3, 2016). The quoted study was in a population of middle aged and elderly men without prostate cancer, similar to the Nymox study population.

"These results are astonishingly good. Other drug treatments and controls tested in similar studies have been associated with a prostate cancer incidence 10 times higher than the results reported by Nymox for fexapotide. This is truly good news. The data strongly indicate that in addition to benefit for BPH symptoms, fexapotide will also help to prevent cancer in these patients," said Dr. Ronald Tutrone, one of the Principal Investigators in the Nymox Fexapotide Prostate Cancer and BPH studies. Dr. Tutrone is Chief of the Division of Urology, Greater Baltimore Medical Center; Medical Director of Chesapeake Urology Research Associates and Chairman of the William E. Kalhert Endowment for Urological Research.

“These exciting results from this long-term prospective analysis confirm what I and other researchers have consistently seen in the clinic -- that it is obvious that fexapotide greatly helps patients in terms of symptomatic benefit for their BPH; and with these results, the clinical benefit also results in much less need for surgical intervention over the long-term. I believe these clinical results, combined with previously reported incidence and progression of prostate cancer in this patient population are truly important. Furthermore, the extreme safety of this new drug and the lack of sexual side effects are remarkably helpful for patients,” said Dr. Mo Bidair, Medical Director of San Diego Clinical Trials in San Diego, CA and an Investigator who has participated for many years in the Fexapotide Clinical Trials.

Clinical trial results from Nymox's Phase 2 clinical program for fexapotide previously have been promptly and frequently reported at large national and international urology meetings, after the completion of the studies. There were peer review publications and over 12 well attended presentations to the AUA and EAU as soon as the Phase 2 data was available. The Company now greatly looks forward to publication of the results and to the upcoming presentations of completed Phase 3 data at national and international medical conferences at the appropriate time.

Dr. Paul Averback, CEO of Nymox said, "The new results now add a third dimension to fexapotide utility: clinical prostate cancer prevention. The drug has now demonstrated statistically significant prospective long-term outcome data showing dramatic reduction in the incidence of newly diagnosed prostate cancer after minimal BPH treatment with fexapotide. Nymox announced in Q3 last year that it will seek regulatory approvals for fexapotide for BPH based on the long-term BPH safety and efficacy data announced Q3 last year. We believe that the exciting new prostate cancer prevention results will add significantly to the evidence in fexapotide's favor towards our goal of widespread major benefit for middle-aged and elderly men."

Dr. Averback added, "These prospective study results in blinded placebo crossover patients clearly demonstrate that fexapotide reduces the long-term need for surgery by up to 82-95% compared to approved conventional BPH treatments. We are extremely grateful to the thousands of people who have been part of these clinical trials. The Company also thankfully acknowledges our shareholders for their long-term commitment that supports these studies."

Nymox has completed and fully financed the execution of seven Phase 3 U.S. BPH (prostate enlargement) clinical protocols, including 2 prospective randomized multicenter single injection double blind clinical trials; 2 U.S. repeat injection clinical trials; and 3 U.S. blinded long-term clinical trial extension studies. In addition, a number of Phase 3 safety and clinical pharmacology studies and analyses have been completed. The Company expects to file for approvals in the next 1-2 quarters. The Company also expects to report further analyses and results when available in the near future.

Fexapotide is a safe and painless single injection treatment given in the urologist's office. The drug is in Phase 3 for BPH and Phase 2 for prostate cancer. It has been tested in over 1700 drug and placebo treatment administrations in the U.S. As a treatment for low grade localized BPH, fexapotide shows long-term efficacy without the safety risk and side effect concerns or added cancer risk associated with currently approved BPH treatments. As a treatment for prostate cancer fexapotide was found to lead to highly statistically significant reduction in disease progression in a large 147 patient multi-year Phase 2 study of U.S. men with low grade cancer.



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