HASBROUCK HEIGHTS, N.J., May 31, 2017 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce statistically significant clinical trial results showing that the Company’s prostate enlargement (BPH) and prostate cancer drug Fexapotide Triflutate produced clinically important improvements in sexual function in first-line patients who received Fexapotide in the Company’s U.S. long-term clinical trials.
Nymox has previously reported the absence of significant 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 improvement 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 demonstrated several lines of prospective randomized double blind evidence indicating sexual function improvement. 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 statistically significant improvement compared to placebo. Placebo treated patients at long-term showed worsening of sexual 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 pre-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 findings 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 significant 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 individual 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 treatments 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 dysfunction, and many other problems. Increased prostate cancer risk has also been attributed to some of the older approved medications. Surgical treatments for BPH are usually effective for urination problems but permanent ejaculatory problems such as retrograde ejaculation are common and surgical side effects and pain can be distressing.
The sexual function improvement data for Fexapotide will be presented in greater detail at medical meetings in the U.S. later this year.
Fexapotide Triflutate is Nymox’s first in class injectable treatment for BPH and low grade localized prostate cancer. The drug is given as a virtually painless injection 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 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 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).
Forward Looking Statements
To the extent that statements contained in this press release are 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 Securities 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 cancer 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, performance 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 statements, 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, 2016, and its Quarterly Reports.
Contact: Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com
