Nymox Pharmaceutical Corporation (Nasdaq:NYMX) provided an update today on the Company's Phase 3 program for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH). The most recent Safety Monitoring Committee meeting of April 30, 2010 for the Phase 3 U.S. pivotal trials of NX-1207 indicated no significant safety concerns for the trials to date. Patient recruitment and trial activities for pivotal U.S. studies NX02-0017 and NX02-0018 are proceeding at over 60 well-known urology investigative sites throughout the US. For more information about the NX-1207 Phase 3 clinical trials please go to www.clinicaltrials.gov or contact Nymox at [email protected]
NX-1207 has been shown to improve the signs and symptoms of BPH, producing improvements which reached statistical significance compared to double-blinded placebo and study controls. A single administration of NX-1207 2.5 mg has produced on average improvements in the standardized BPH symptom score (8-10 points) that were approximately double that reported for currently approved BPH drugs (3-5 points). The drug is administered by a urologist in an office setting and involves little or no pain or discomfort. NX-1207 has not been found to have the sexual, blood pressure, or other side effects of the approved drugs. Follow-up studies have shown clinical efficacy effects in men lasting up to 5 years after a single treatment.
In a recently published peer-reviewed publication entitled, NX-1207: a novel investigational drug for the treatment of benign prostatic hyperplasia, written by Neal Shore MD FACS, Medical Director of the Carolina Urologic Research Center, Myrtle Beach, SC, in Expert Opinion on Investigational Drugs, the author wrote "Regarding existing oral drug therapies, the use of NX-1207 would obviate daily and lifelong compliance issues as well as the ongoing concerns of polypharmacy facing the elderly and the attendant risk for drug–drug interactions. In comparison to office-based MIST options, the transrectal injection approach afforded by NX-1207, both anesthetic/analgesic free as well as catheter free, will be quite compelling to most patients. If the ongoing Phase III trials can duplicate the success seen in earlier trials, for both efficacy and safety, then the administration of NX-1207 should be expected to significantly impact the current pattern of treatment options employed by urologists for their patients with BPH". The paper is available online at http://informahealthcare.com/doi/abs/10.1517/ 13543780903555196.
BPH is one of the most commonly diagnosed diseases in the male U.S. population. The condition can seriously impact the health and quality of life of older men and can lead to acute urinary retention, incontinence, and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.
SOURCE Nymox Pharmaceutical Corporation