drugset / Press release

Nymox Pivotal Phase 3 NX-1207 BPH Extension Trial Successfully Meets Primary Endpoint. Company Plans to File For Regulatory Approvals For Fexapotide Triflutate (NX-1207).

2015-07-27 · Nymox Corporation · original nymox.com ↗

Contact: Paul Averback Nymox Pharmaceutical Corporation 800-93NYMOX www.nymox.com For Immediate Release: Nymox Pivotal Phase 3 NX-1207 BPH Extension Trial Successfully Meets Primary Endpoint. Company Plans to File For Regulatory Approvals For Fexapotide Triflutate (NX-1207). HASBROUCK HEIGHTS, NJ (July 27, 2015) Nymox Phar maceutical Corporation (NASDAQ:NYMX) announced today that the Company's U.S. long- term extension prospective double-b lind Phase 3 BPH studies NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BP H have successfully met the pre-specified primary endpoint of long-term symptomatic statistically signific ant benefit superior to placebo. Fexapotide showed an excellent safety profile with no eviden ce of drug-related short-term or lo ng-term toxicity nor any significant related molecular side effects in the 2 studies (n=978). The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories. The Company will present a public webinar and conference call today July 27 at 4:30 p.m. EDT (see below). The primary endpoint variable of the long-term study was improvement in the AUA BPH Symptom Score which was statistically significant (p<.02) in fexapotide-treat ed patients compared to placebo, at a median duration of 42 months (3.5 years) after a single double-blind injection treatment of fexapotide vs. saline placebo. In addition, responder analysis for the primary endpoint variable me t the prespecified endpoint (p<.01). All subjects from both studies with 2 years or more duration follow-up afte r a single painless injection were eligible, however all documented treatment failures of any dur ation in the studies from day 1 onwa rd were also included in the data as treatment failures. Patients were followed double-blind up to 65 months (5.4 years) after a single injection. Highlights of the pivotal Phase 3 extension top-line results are summarized as follows: • Median duration of 3.5 years from a single inject ion treatment mean improvement of 5.3 points in AUA BPH Symptom Score. Statistically significant (mean p<.025; median p<.02) vs saline placebo injection. • Mean improvement of 7.1 points in AUA BPH Sympto m Score (primary endpoint variable) after median duration of 3.5 years in first-line BPH treatment of fexapotide treated subjects (p<.025 vs placebo). • Patient responder rate: Statistically significant high er proportion (64%) of long-term improved patients in AUA BPH Symptom Score (primary outcome variable) after a single injection in fexapotide treated subjects vs controls (p<.005). • Improvement of nocturia: Percentage of patients with stabilization or improvement of frequency of nocturia in fexapotide treatment superior to placebo (p<.03). The Company also reported on new Phase 3 data of lowered incidence of surgery in patients in Phase 3 studies NX02-0020 and NX02-0022. • Reduced incidence of surgery: Subjects in Phas e 3 studies NX02-0020 and NX02-0022 with 1 or 2 injections of fexapotide had statistically signific ant reduction of BPH surgery within 24 months of fexapotide treatment (1.7% incidence of surgery in 2 years) (p<.02 vs placebo). In addition, the following advantages of the new drug are highlighted: NEWS RELEASE • Safety profile highly superior to existing treatments. Minimal or no sexual, hormonal or cardiovascular or other debilitating side effects. • Reduced cancer risk in Phase 2 data: U.S. Phase 2 data showing therapeutic effect of fexapotide on prostate cancer. Phase 2 data showed fexapotide trea ted low grade localized prostate cancer (Gleason 3+3 or less) had statistically significant less progr ession compared to controls. By comparison, some commonly used older approved BPH treatments have been linked to increased cancer risk. • Enhanced compliance and patient convenience compared to oral medications. Fexapotide is given as a single painless office treatment inje ctable. Older approved oral medicati ons generally involve daily pills intended for the rest of the patient’s life. Conference 4:30pm: To participate in the conference pleas e go to: http://bit.ly/nymox_7_15_reg Registration is required. After registration, a link is provided to the we bcast. For registration prior to 30 minutes before the webcast, bookmark the page, or save the link to access the page at the time of the conference. Questions may be submitted at any time by using the form under the pl ayer window. Time may not allow us to address all questions. For best results, close other applications prior to going to the webcast page. The webcast is also viewable on mobile devices. If using a desktop, Flash 10 is required, which may be downloaded at http://get.adobe.com/flashplayer/ Mobile devices without Flash are also supported. Forward Looking Statements To the extent that statemen ts contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking st atements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Priv ate Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH, the potential of NX-1207 to treat BPH and the estimated timing of further developments for NX-1207. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical devel opment program, future results, performance or achievements to differ significantly fr om those expressed or implied by th e forward-looking statements. Such risks and uncertainties include, among others, the unce rtainties inherent in the c linical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on NX-1207, Nymox's commercialization plans a nd efforts and other matters that could affect the availability or commercial potential of NX-1207. 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 forwar d-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 Fo rm 20-F for the year ended December 31, 2014, and its Quarterly Reports.

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