Nymox Announces Validation By The European Member States Of European Marketing Authorization Application For Fexapotide Triflutate For Benign Prostatic Hyperplasia
Published: Sep 15, 2017
HASBROUCK HEIGHTS, N.J., Sept. 14, 2017 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce today that the European Member States for Nymox's Marketing Authorization Application (MAA) for Fexapotide Triflutate for the treatment of benign prostatic hyperplasia (BPH, prostate enlargement) have accepted the Company’s MAA. With this validation, the Nymox application is complete and regulators from the member countries formally acknowledge that the Company has provided the requested documentation necessary for the MAA to be reviewed.
"With the acceptance of the MAA, the Member States officially acknowledge that the Company has provided all the required information and documentation necessary for the formal review process. The acceptance of this MAA is an important milestone in our goal to bring this first in class treatment candidate to countless men suffering from the symptoms of BPH. Nymox looks forward to working with European regulators to help patients with BPH attain the benefits that treatment with Fexapotide Triflutate may offer." said Dr. Paul Averback, CEO of Nymox.
Fexapotide Triflutate is Nymox's first in class injectable treatment candidate 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.
Fexapotide has been in development for over a decade and has been found in trials 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 clinical program has also shown in long-term studies >80% reduction in the number of crossover Fexapotide treated patients who required surgery for their BPH as compared to patients who received crossover conventional approved BPH treatments. Fexapotide led to long-term improvement in sexual function as reported by first-line patients who received the new drug.
BPH is extremely common and afflicts middle aged and elderly males, affecting millions of men worldwide with chronic lower urinary tract symptoms, and often requires surgical treatments.
For more information please contact email@example.com or 800-936-9669.
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.
Nymox Pharmaceutical Corporation