Nymox (NYMX) Reports Strong Data from Follow-Up Assessment of NX-1207 in BPH Patients
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Nymox Pharmaceutical Corporation (Nasdaq: NYMX) is pleased to report positive new results from the 52-56 month follow-up study of patients who participated in the company's U.S. Study NX02-0016 of NX-1207 for the treatment of BPH (benign prostatic hyperplasia or enlarged prostate) completed in 2007. The results of the follow-up study provided evidence confirming the durable benefits from NX-1207 treatment for BPH. Two blinded placebo-controlled Phase III studies of NX-1207 2.5 mg for the treatment of BPH as well as a third open label safety study are currently underway in the U.S. and nearing full enrollment. The company and its European partner, Recordati, recently announced the start of a Phase III clinical trial in Europe for NX-1207 for BPH.
The new follow-up study assessed American Urological Association BPH Symptom Index scores and treatment outcomes in blinded subjects 52-56 months after a single initial injection of NX-1207 2.5 mg. No significant drug safety problems were reported by any subjects in the study initially as well as in the new long-term follow-up. The new follow-up study found that of the patients who received NX-1207 2.5 mg, 52% were not currently taking BPH medication and had not received surgical treatments for their BPH; and 36% had required no medical or surgical treatments for their BPH since receiving their initial dose of NX-1207 2.5 mg. In the control group only one subject had not required any additional BPH treatments. The 36% of patients who received NX-1207 2.5 mg and did not require any other subsequent treatment for their BPH reported on average a 12.5 point improvement in their BPH symptom scores at 52-56 months; the 52% not currently taking BPH medication reported an average 10.0 point improvement. The level of symptomatic improvement for both NX-1207 2.5 mg cohorts reached statistical significance.
In the new follow-up study patients were followed and have remained blinded as to treatment subsequent to their participation in Nymox's U.S. Study NX02-0016. The initial study was undertaken in 2007 at 32 U.S. sites and enrolled 85 subjects. 53% of the NX-1207 2.5 mg subjects and controls were available for the follow-up study.
In the initial NX02-0016 study's Intent-to-Treat cohort after 90 days, patients treated with NX-1207 2.5 mg had a mean BPH Symptom Score improvement of 9.71 points, which was markedly better than the improvement shown by control groups (p<.001). The tested therapeutic dose of NX-1207 2.5 mg also reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 6 months post-treatment.
The new follow-up study assessed American Urological Association BPH Symptom Index scores and treatment outcomes in blinded subjects 52-56 months after a single initial injection of NX-1207 2.5 mg. No significant drug safety problems were reported by any subjects in the study initially as well as in the new long-term follow-up. The new follow-up study found that of the patients who received NX-1207 2.5 mg, 52% were not currently taking BPH medication and had not received surgical treatments for their BPH; and 36% had required no medical or surgical treatments for their BPH since receiving their initial dose of NX-1207 2.5 mg. In the control group only one subject had not required any additional BPH treatments. The 36% of patients who received NX-1207 2.5 mg and did not require any other subsequent treatment for their BPH reported on average a 12.5 point improvement in their BPH symptom scores at 52-56 months; the 52% not currently taking BPH medication reported an average 10.0 point improvement. The level of symptomatic improvement for both NX-1207 2.5 mg cohorts reached statistical significance.
In the new follow-up study patients were followed and have remained blinded as to treatment subsequent to their participation in Nymox's U.S. Study NX02-0016. The initial study was undertaken in 2007 at 32 U.S. sites and enrolled 85 subjects. 53% of the NX-1207 2.5 mg subjects and controls were available for the follow-up study.
In the initial NX02-0016 study's Intent-to-Treat cohort after 90 days, patients treated with NX-1207 2.5 mg had a mean BPH Symptom Score improvement of 9.71 points, which was markedly better than the improvement shown by control groups (p<.001). The tested therapeutic dose of NX-1207 2.5 mg also reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 6 months post-treatment.
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