drugset / Press release

Sexual Function Improves in First-Line Patients Given Fexapotide Treatment in Nymox U.S. BPH Long-Term Clinical Trials

2017-05-31 · Nymox Corporation · original nymox.com ↗

Contact: Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com For Immediate Release: Sexual Function Improves in First-Line Patients Given Fexapotide Treatment in Nymox U.S. BPH Long-Term Clinical Trials HASBROUCK HEIGHTS, NJ (May 31, 2017) Nymox P harmaceutical Co rporation (NASDAQ:NYMX) is pleased to announce statistically significant clinical trial results showing that the Company's prostate enlargement (BPH) and prostate cancer drug Fex apotide Triflutate produced clinically important improvements in sexual function in first-line patient s who received Fexapotide in the Company's U.S. long- term clinical trials. Nymox has previously reported the absence of significa nt sexual or other side effects from Fexapotide treatment of prostate enlargement or prostate cancer based on 15 years of clinical research in prospective randomized trials in the U.S. However actual improvem ent in sexual function (which is very different from absence of debilitating sexual side effects) is a newly reported and important finding. Patients in the Company's Phase 3 Fexapotide U.S. trials were administered a validated standardized Sexual Function Questionnaire (SFQ) at baseline, in the first 12 months, and at long-term after a single injection in the Phase 3 pivotal trials NX02-0017 and NX02-0018, and prior to re-injection in Phase 3 studies NX02-0020 and NX02-0022. The trial data demon strated several lines of prospective randomized double blind evidence indicating sexual function improv ement. At 12 months after treatment in the first-line previous treatment-naive patients (n=370), there was a statistically significant improvement from baseline in Fexapotide treated subjects (p<.0001), while placebo showed no improvement from baseline. In first-line previous treatment-naive subjects with SFQ long-term assessments (12-51 months after treatment, n=156), the Fexapotide treated subjects had st atistically significant improvement compared to placebo. Placebo treated patients at long-term showed worsening of se xual function (mean -0.88 points) while Fexapotide treated patients showed improvement (+0.64 points, p=.0049). The percentage of first-line previous treatment-naive patients in the study with pr e-existent sexual dysfunction (baseline SFQ ≤3 points) who ended the study improved and no longer with self-reported sexual dysfunction (SFQ ≥4 points) was statistically significant (p<.05) while there was no change in the placebo group. Paul Averback MD, CEO of Nymox said, "The findi ngs newly reported today add another important dimension to the advantages of Fexapotide treatment for BPH. In addition to absence of sexual side effects, there is now statistically significant prospective clinical trial evidence of sexual functional improvement in men with prostate enlargement given Fexapotide." Nymox has previously reported the absence of significa nt sexual or other side effects from Fexapotide treatment of prostate enlargement or prostate cancer based on 15 years of clinical research in prospective randomized trials in the U.S. In over 1700 individua l treatments with Fexapotide or placebo, there have been no significant side effects linked to the drug, and no significant evidence of sexual side effects. This is in marked contrast to traditional approved treatment s for BPH. Alpha blocker drugs and 5-alpha reductase inhibitor oral medications for BPH are well known to commonly produce sexual and other side effects that limit these older drugs' usefulness and tolerability for patients. It is not uncommon for patients on oral medications to suffer from chronic loss of libido, impotence, ejaculatory dysf unction, and many other problems. Increased prostate cancer risk has also been attributed to some of the older approved medications. Surgical treatments for BPH are usua lly effective for urination problems but permanent NEWS RELEASE ejaculatory problems such as retrograde ejaculation are common and surgical side effects and pain can be distressing. The sexual function improvement data for Fexapoti de will be presented in greater detail at medical meetings in the U.S. later this year. Fexapotide Triflutate is Nymox's first in class inject able treatment for BPH and low grade localized prostate cancer. The drug is given as a virtually painless inject ion with no anesthesia, analgesia or catheterization, and is an office procedure which takes a few minutes to administer. On May 3, 2017 Nymox announced that it had filed for marketing approval in Europe for Fexapotide Triflutate for the treatment of prostate enlargement (BPH benign prostatic hyperplasia). Nymox's lead drug Fexapotide has been in development for over 15 years and has been tested by expert clinical trial investigative teams in over 70 distingui shed clinical trial centers throughout the US, and has been found after 7 years of prospecti ve placebo controlled double blind studies of treatment of 995 U.S. men with prostate enlargement to not only show clin ically 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 crossover group study an 82- 95% reduction in the number of these patients who required surgery after they received crossover Fexapoti de in the trial, as compared to patients who did not receive Fexapotide but instead received crossover conventional approved BPH treatments (p<.0001). 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 invo lve substantial risks and uncertainties that could cause our clinical development program, future result s, performance or achievement s to differ significantly from those expressed or implied by the forward-looki ng statements. Such risks a nd uncertainties include, among others, the uncertaintie s inherent in the clinical drug developm ent 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 co uld 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 stat ements, as well as risks relating to the business of Nymox in general, see Nymox's current and future r eports 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.

The release as fetched from its publisher. nymox.com ↗