About Fexapotide Triflutate
Summary of Reported Results of U.S. Studies of Fexapotide Triflutate For BPH
Fexapotide Triflutate (NX-1207) is an office-based pro-apoptotic protein injectable for BPH and for low grade localized prostate cancer. The drug mechanism of action is to lead to programmed natural cell death (apoptosis) selectively in prostate glands when injected intraprostatically by the transrectal route. Adjacent tissues and structures (such as nerves, bladder, rectum, urethra and periprostatic tissues) are unaffected by Fexapotide. To date, over 1700 men have been injected by the transrectal route with Fexapotide or placebo in U.S. trials. There have been no significant safety events attributed to the molecule in over a decade of studies.
Phase 3 studies NX02-0017, NX02-0018, NX02-0020, and NX02-0022 for BPH were initiated in 2009-2013 at over 70 sites throughout the U.S. Long-term double blind data from 995 randomized subjects was compiled and analysis completed in 2017. A sub-group of 344 blinded (as to initial injection) patients also received cross-over Fexapotide at 12-50 months after their initial blinded treatment in 2 studies.
Prospective Phase 3 Efficacy Results:
The following were statistically significant prospective findings from the U.S. Phase 3 trials:
1. Long-term (mean duration 3.5 years) BPH Symptom Score improvement (>5 points; statistically significant vs placebo). (Long-term primary endpoint).
2. Long-term (3 years post randomization) statistically significant, >80% reduction in incidence of surgical treatment for BPH in blinded placebo patients crossed over to Fexapotide vs placebo crossover to conventional oral medications;
3. Long-term (4 year) reduction in the incidence of verified prostate cancer newly diagnosed after 12 months or later (incidence <1.5%, statistically significant vs placebo);
4. Long-term improvement or stabilization of nocturia (statistically significant vs placebo);
5. Long-term BPH Symptom Score improvement in first-line (prior BPH treatment-naive) patients (mean >6 points, statistically significant vs placebo).
6. Sexual function questionnaire improvements in first-line treated subjects (+0.64 points) vs sexual function worsening (-0.88 points) in placebo subjects (statistically significant).
7. Percentage BPH Symptom Score responder analysis statistically significant vs placebo.
Long-term safety of single and repeated injection. No significant safety events attributed to the molecule. No difference from placebo in number or types of related or unrelated adverse events.
No detectable immunological reactions. No significant sexual side effects. No detectable effect on testosterone levels.
Forward Looking Statements
To the extent that statements contained herein 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.