- Absence of tumors (Primary Endpoint) controlled for size in baseline area: fexapotide 15 mg superior to control (p=.035); crossover fexapotide 15 mg superior to control (p=.002); crossover fexapotide overall superior to control (p=.014).
- 75.5% reduction in biopsy proven prostate cancer Gleason upgrades (pathological progression) after 18 months in fexapotide 15 mg treated patients compared to control (p=.0055). 71.7% reduction in prostate cancer Gleason upgrades in fexapotide treated patients overall (p=.0045 vs controls).
- 84.8% reduction after 18 months in surgery or radiotherapy instituted for prostate cancer Gleason upgrade (biopsy worsening) in fexapotide treated patients overall compared to control group (p=.014).
- 54.8% reduction after 18 months in surgery or radiotherapy instituted for all causes with or without prostate cancer Gleason upgrade in fexapotide 15 mg treated patients compared to control (p=.026).
- Significant improvement for fexapotide patients compared to controls in 4 out of 4 Secondary Endpoints. Tumor volume reduction in the treated area, combined dosages (p=.04); tumor volume change in prostate overall, fexapotide patients overall (p=.014); median tumor grade outcome in the treated area, all dosages (fexapotide median benign, vs control median Gleason 3+3), and superior median tumor grade in prostate overall, fexapotide 15 mg vs controls.
- Consistent safety results with no significant drug-related adverse events and no significant related sexual adverse events.
- Overall superior results for the fexapotide 15 mg dose compared to the 2.5 mg dose (dose-response).
- Other statistically significant improvement outcomes in fexapotide patients compared to controls, to be presented comprehensively at medical meetings.
Dr. Averback added, "Based on these outcomes, we believe there are exciting potential patient benefits from one or more painless fexapotide office injections for this common and distressing condition."The Company will report at a later date concerning its plans for moving the compound forward toward the market for this important medical problem. For more information please contact firstname.lastname@example.org 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.
Paul AverbackNymox Pharmaceutical Corporation800-93NYMOXwww.nymox.com