drugset / Press release

Nymox Reports Additional Positive Results From Completed Fexapotide BPH Phase 3 Studies Showing Significant Early Response and First-Line Efficacy

2016-11-29 · Nymox Corporation · original nymox.com ↗

Contact: Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com For Immediate Release: Nymox Reports Additional Positive Results From Completed Fexapotide BPH Phase 3 Studies Showing Significant Early Response and First-Line Efficacy HASBROUCK HEIGHTS, NJ (Novembe r 29, 2016) Nymox P harmaceutical Corporation (NASDAQ:NYMX) is pleased to announce that new Phase 3 prospective randomized clinical trial results have confirmed that patients who received fexapotide as their initial treatment for BPH (prostate enlargement) had superior efficacy results as early as 10 days compared to co ntrol patients who received placebo or who had prior history of other BPH medical treatments. These new Phas e 3 results indicate that fexapotide in these trials was highly efficacious for first-line treatment of BPH. These findings are from analysis of the Company's extensive U.S. Phase 3 tr ials NX02-0017, NX02-0018, NX02-0020 and NX02-0022 including long-term follow-ups that were undertaken from 2009 to 2016. These important results come on top of many other positi ve results including successfully reaching long-term primary efficacy endpoints, that hav e previously been reported. The pr esent prospective randomized trial results are new findings. 390 treatment naive patient s with no past treatments for BPH had improvements greater than previously treated BPH patients as early as 10 days post-treatment (p<.02) and at one month (p<.04), 3 months (p<.001), six mont hs (p<.001), one year (p<.01) and at long-term (3.5 years) follow-up (p<.003). The levels of mean change from baseline pre-treatment ranged from 6.49 to 8.88 points improvement in the AUA BPH Symptom Score. These previously untreated patients who received a single injection of fexapotide 2.5 mg also had statistically significant superior improvements compared to patients who received placebo treatments, as early as 10 da ys post-treatment (p<.001) and at several time points also including the long-term (3.5 years) follow-up extension (p<.001). Dr. Paul Averback, CEO of Nymox said, "It is importa nt to have now demonstrated for Nymox's fexapotide, both 1. that it leads to an early onset of clinically noticeable improvement; and 2. that it works well long-term as a first-line therapeutic for men who have not trie d other treatments before. There is a major unmet need for a convenient, safe and efficacious treatment fo r countless men worldwide with BPH who are unhappy with their symptoms and who may be unhappy with their available choices." Traditional BPH treatments have very undesirable side e ffects, particularly causing frequent problems with ejaculation and overall sex ual function, as well as many other limi ting side effects. Pills for BPH usually need to be taken permanently to remain effective and surgical treatments for BPH often produce permanent distortions of ejaculation as well as other risks. Middle aged and elderly male patients often need a safer and more effective way to manage these extremely common life problems. Nymox's lead drug fexapotide has been in development for over a decade 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 dise ase. The same clinical program conducted at the same highly regarded treatment center s under rigorous trial scrutiny and performed strictly at arms-length by top teams of clinical investigat ors across the country, 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 NEWS RELEASE received crossover fexapotide in the trial, as comp ared 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 fexapoti de 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 surgic al treatment. In that study long-term outcomes were determined in 391 patients who were given double blind placebo injections, 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 earlier fexapotide Phase 3 long-term cancer incidence analysis, the men in the study received fexapotide or placebo for the treat ment 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 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 publ ished large trials of drugs for the prevention of prostate cancer, the incidence of new prostate canc er cases after 4-7 years has been reported in major studies to be 20-25%. The data analysis from the Nymo x fexapotide study showed a 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 Jour nal 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. Nymox recently announced (October 11, 2016) positive l ong-term results in 344 patients who were given a single repeat fexapotide treatment after initial blinded treatment with fexapotide or placebo. Patients were followed for 2 to 6.5 years (mean 4.2 years) after in itial treatment and showed long-term statistically significant symptomatic improvement (mean improvement of 6.5 points in the AUA BPH Symptom Score) compared to Phase 3 patients who received placebo al one (p<.001). Repeat injection was found to be safe with no significant drug related toxicities or side effects found in the study. Nymox has completed the execution of seven Phase 3 U. S. BPH 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. 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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