Nymox Pharma (NYMX) Announces Additional Positive Data from Fexapotide Phase 3 in BPH
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Nymox Pharmaceutical Corporation (Nasdaq: NYMX) announced 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 control patients who received placebo or who had prior history of other BPH medical treatments. These new Phase 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 trials 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 positive results including successfully reaching long-term primary efficacy endpoints, that have previously been reported. The present prospective randomized trial results are new findings. 390 treatment naive patients 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 months (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 days 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 important 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 tried other treatments before. There is a major unmet need for a convenient, safe and efficacious treatment for 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 effects, particularly causing frequent problems with ejaculation and overall sexual function, as well as many other limiting 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 distinguished clinical trial centers throughout the US, and 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. 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 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 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 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 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 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 data analysis from the Nymox 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 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.
Nymox recently announced (October 11, 2016) positive long-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 initial 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 alone (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.
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