IRVINE, Calif., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) (the "Company") is pleased to announce that the Company's recent submission of Fexapotide Triflutate for the treatment of symptoms of benign prostate enlargement (benign prostatic hyperplasia, referred to as BPH) has been validated by the Denmark authorities, and the formal review process has now started. The trademarked name for the new product is NYMOZARFEX (TM). The Marketing Authorization Application (MAA) was submitted at the beginning of December 2022. The Company will continue to provide further information, including other expected submissions, when the information becomes available.
Paul Averback MD, CEO of Nymox said, "We are extremely pleased that the Nymozarfex (TM) MAA submission was accepted for review. We again thank our long-term supporters and all team members for their solid contributions involved in the ongoing process. We will continue to provide updates and communications whenever appropriate."
About NYMOZARFEX (TM) (Fexapotide)
NYMOZARFEX (TM) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 BPH patients with over 1600 injections administered including over 1200 Fexapotide administrations. Fexapotide has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments.
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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, 2021, and its Quarterly Reports.
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Nymox Pharmaceutical Corporation
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