(By Balaseshan) Nymox Pharmaceutical Corp. (NASDAQ: NYMX) said it has completed patient enrollment in its pivotal U.S. Phase 3 NX02-0017 study of NX-1207 for benign prostatic hyperplasia (BPH).
NX-1207 is in late stage Phase 3 development in the U.S. for the treatment of benign prostatic hyperplasia (BPH), a common condition of older men associated with growth in prostate size as men age.
This study is now closed to further enrollment. Top-line results from the large Phase 3 Study are expected in late 2013.
The company's NX02-0018 Phase 3 trial is expected to reach full enrollment in the near future. Phase 3 trial activities of NX-1207 for BPH have begun in Europe sponsored by Recordati S.p.A., the company's European licensing partner.
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In the BPH studies to date, a single dose of NX-1207 has been found to produce symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs.
BPH causes progressive difficulties with urination, such as nocturia, urge to void frequently, acute urinary retention and other problems. The condition can seriously impact the health and quality of life of middle aged and older men.
It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and a high proportion of men as they age suffer from moderate to severe urinary problems and symptoms associated with BPH.
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NX-1207 is also being evaluated for the treatment of low risk localized prostate cancer where NX-1207 is administered directly into the area of the prostate where the cancer was detected. A U.S. Phase 2 study (NX03-0040) for that indication is in progress.
NYMX is trading up 12% at $7.31 on Wednesday. The stock has been trading between $5.69 and $8.98 for the past 52 weeks.