HASBROUCK HEIGHTS, N.J., May 03, 2017 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce today that the Company has filed to seek approval for marketing authorization for Fexapotide Triflutate in five European countries, comprising the Netherlands, the UK, Germany, France and Spain. This first filing for Fexapotide Triflutate is for the indication of treatment of the symptoms of BPH (benign prostatic hyperplasia; prostate enlargement).
"Fexapotide has the real potential to alter the way BPH will be treated in the future. There is a major unmet medical need for a safe and efficacious treatment method for the many men who suffer from this age-related malady," said Dr. Paul Averback, CEO of Nymox.
"This first filing represents a major corporate milestone for the development of Fexapotide. We are extremely pleased to achieve this milestone which is based on intensive work carried out by our teams and many expert collaborators over the past 15 years," Dr. Averback added.
Erik Danielsen, Nymox's CFO added, "Going forward, we expect to announce further regulatory filings for approval in additional important jurisdictions around the world as well as corporate initiatives supporting our pre-commercialization efforts. We now plan to significantly step up our communication programs with both the medical as well as the financial communities. Today's important step forward will be followed up by additional strategic business development activities."
Fexapotide has been in development by Nymox for 15 years. Clinical trials have shown long-term symptomatic improvement, long-term reduction in the need for BPH surgery, long-term reduced prostate cancer risk, and an excellent long-term safety profile with no sexual side effects in comparison to available drug treatments. Fexapotide Triflutate is administered at an office visit and consists of a single painless injection that takes a few minutes or less, with no requirements of anesthesia, or analgesia or catheterization. There are none of the typical sexual and other distressing side effects seen with conventional BPH treatments.
BPH is highly prevalent in middle aged and elderly men, affecting millions of men world-wide. Existing medical treatments for BPH generally provide temporary relief only, and are commonly discontinued by patients due to side effects and little efficacy. Surgical treatments are effective but often have permanent retrograde ejaculation as a result, and other problems and risks are associated.
Nymox will hold a teleconference call for shareholders next week. Further details regarding the teleconference will be announced in advance of the call.
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.