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news.Nymox Pharmaceutical has announced that the last enrolled patient has completed participation in the company's pivotal Phase III clinical trial, NX02-0018.
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The NX02-0018 trial is the second of two pivotal prospective double blind placebo-controlled US clinical trials being conducted to evaluate NX-1207 2.5mg for the treatment of benign prostatic hyperplasia (BPH), a common affliction of older men.
The first pivotal Phase III trial of NX-1207 for BPH, NX02-0017, has already completed patient participation. Both trials will be unblinded once data verification and auditing activities have been completed.
NX-1207 is a novel patented drug developed by Nymox for the treatment of BPH and localized prostate cancer. The drug is administered by a urologist in an office setting directly into the zone of the prostate to be treated. The procedure takes only a few minutes, does not require sedation, anesthesia or catheterization, and involves little or no pain or discomfort.
NX-1207 had previously successfully completed a series of blinded controlled multi-center U.S. clinical trials for BPH where a single 2.5mg dose of NX-1207 was found to produce at 90 days an average improvement in standardized symptom score about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs.
Follow-up studies showed evidence of long lasting benefit with a significant proportion of men who received a single dose reporting maintained improvement in BPH symptoms without other treatments for up to five years or more.
The company recently announced top line results of its two dose (2.5mg or 15mg) blinded prospective controlled Phase II study of NX-1207 for the treatment of localized low-risk prostate cancer, NX03-0040. Results indicated an overall benefit in terms of reduced cancer progression in patients treated with a single injection of NX-1207 into the area of the prostate where cancer was found as compared to active surveillance (no treatment) controls.
Follow-up analysis after up to 22 months found that for patients with upgraded biopsies in the treated area, those treated with NX-1207 required 85% less radiation and surgery treatments compared to controls. Consistent with earlier clinical trial experience with NX-1207, there were no significant safety issues or side effects associated with either the high dose (15mg) or low dose (2.5mg) of the drug in this study.