- The Company is moving forward with the activities of preparing for filing for approval of fexapotide triflutate (NX-1207) 2.5 mg for the treatment of prostate enlargement (BPH). The Company is pleased with the solid progress that has been made. The date(s) of anticipated filing will be reported in due course.
Dr. Paul Averback, CEO said "Our management team has over the past several months been very focused on taking the necessary steps that will allow our Company to file for regulatory approvals for fexapotide triflutate in various markets. We expect to provide an update in the near future with regard to the filing for approval for our BPH drug fexapotide triflutate."Phase 3 trial results for fexapotide showed excellent safety profile and after 3.5 years statistically significant increased improvement in symptom scores vs placebo; statistically significant increases in responder rates vs placebo; statistically significant decrease (after 2 years) in need for surgery vs placebo; and statistically significant better nocturia outcomes vs placebo. Fexapotide is associated with a decrease in prostate cancer risk. By comparison, some commonly used approved BPH treatments have been linked to increased cancer risk. Fexapotide has enhanced compliance and patient convenience compared to oral medications. Fexapotide is given as a single painless office treatment injectable. Approved oral medications generally involve daily pills intended for the rest of the patient's life.
- The 18 month low grade localized prostate cancer trial of fexapotide 2.5 mg and 15 mg has been completed, and results are nearing completion of analysis. The timing of reporting of results is on target and top-line data will be presented in the very near future.
With reference to the Company's quarterly financial filings, the international clients of Cutler & Co. have been acquired by transfer of responsibility to Thayer & O'Neal of Houston, Texas. Due to this recent transfer the Company's quarterly filings have been slightly delayed and will be filed in the very near term.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, 2014, and its Quarterly Reports.
Contact:Paul AverbackNymox Pharmaceutical Corporation800-93NYMOXwww.nymox.com