Nymox’s New Phase 3 Long-Term U.S. Results For Prostate Enlargement Drug Fexapotide Show
2016-08-29 · Nymox Corporation · original nymox.com ↗
Contact: Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com For Immediate Release: Nymox's New Phase 3 Long-Term U.S. Results For Prostate Enlargement Drug Fexapotide Show 1. Dramatic Decrease in Prostate Cancer and 2. Major Reduction in Need For BPH Prostate Surgery HASBROUCK HEIGHTS, NJ (August 29, 2016) Nymox Pharmaceutical Corporation (NASDAQ:NYMX) lead drug fexapotide which has been in development for ov er a decade and which has been tested by expert clinical trial investigative teams in over 70 distingu ished 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 mean ingful and durable relief of BPH symptoms, but also to show a major reduction in the incidence of pros tate cancer, compared to placebo and compared to the known and expected normal incidence of the disease. Th is 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 su ch as retrograde ejaculation which is when men lose the ability to have normal orgasms. The same clinical program conducted at the same hi ghly regarded treatment cent ers 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 require d 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 ai m 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 followe d by crossover to other tr eatments 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) symp toms. All men were thoroughly evaluated at expert urological testing investigational centers to exclude an y 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 pr evention 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 fe xapotide treated BPH populat ion. By comparison, for example in a population of patients with erectile dysfun ction treated with PDE5 inhibitor drugs after 4 years the rate of subsequent prostate cancer was 19.5% ( and 22.7% in controls) as re cently 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. NEWS RELEASE "These results are astonishingly good. Other drug treat ments 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 Canc er 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 obv ious 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 prev iously have been promptly and frequently reported at large national and internati onal 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 Com pany now greatly looks forward to publication of the results and to the upcoming presentat ions of completed Phase 3 data at national and international medical conferences at the appropriate time. Dr. Paul Averback, CEO of Nymox sa id, "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 announ ced in Q3 last year that it will seek regulatory approvals for fexapotide for BPH based on the long-ter m BPH safety and efficacy data announced Q3 last year. We believe that the exciting new prostate cancer prevention re sults 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 prospe ctive study results in blinded pl acebo crossover patients clearly demonstrate that fexapotide redu ces 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 pros pective 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 treatm ent 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 treatme nt for low grade localized BP H, fexapotide shows long- term efficacy without the safety risk and side effect c oncerns 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 pat ient multi-year Phase 2 study of U.S. men with low grade cancer. For more information please contact [email protected] or 800-936-9669. Forward Looking Statements To the extent that statem ents contained in this press release ar e 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 Se curities 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 ca ncer 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, pe rformance 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 st atements, 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, 2015, and its Quarterly Reports.
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