HASBROUCK HEIGHTS, N.J., April 16, 2019 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NYMX) today announced that it has held its pre-New Drug Application (NDA) Chemistry Manufacturing and Controls (CMC) meeting with the US Food and Drug Administration (FDA) regarding its lead product candidate Fexapotide Triflutate, a novel prostate injectable developed for the treatment of enlarged prostate (Benign Prostatic Hyperplasia, BPH). The purpose of the April 15 meeting was to discuss the CMC data package for Fexapotide, an important regulatory requirement prior to the NDA submission. Nymox is pleased to report that it considers the meeting was constructive and positive. The authorities did not raise any serious or unexpected issues with regard to Nymox’s CMC data package, which was submitted prior to the meeting.
Mark Staples, Nymox’s VP of Chemistry, Manufacturing and Controls, commented: “We are pleased with the outcome of this important meeting and the feedback we got from the Agency. We believe that the Chemistry, Manufacturing, and Quality Control sections of our NDA filing in the U.S. will provide the technical knowledge base required to fully meet the safety and performance expectations for a commercial therapeutic product. We recognize the fundamental importance of the CMC contribution to an NDA filing and, therefore, consider this meeting an important milestone in our efforts towards successful filing of the NDA for Fexapotide for BPH in the U.S. later this year.”
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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, 2018, and its Quarterly Reports.
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