Nymox Announces Positive New Results in 7 Year Study of NX-1207 for Benign Prostatic Hyperplasia
HASBROUCK HEIGHTS, NJ (March 16, 2011) Nymox Pharmaceutical Corporation (NASDAQ: NYMX) today announced new 2011 positive results from a long term outcome study of NX-1207 for benign prostatic hyperplasia (BPH). The study evaluated symptomatic change and treatment status of patients involved in the Company’s NX02-0012 and NX02-0013 Phase 1-2 U.S. studies of NX-1207 initially undertaken in 2003. The new data indicates that a significant percentage of patients given a single treatment of NX-1207 have now shown sustained improvement in their symptoms without other treatments for over 7 ½ years.
Patients treated with NX-1207 were followed-up on an unselected and as available basis and assessed for symptomatic improvement, treatment outcomes, and durability of efficacy 7 ½ years after a single treatment with NX-1207. As an inclusion criterion, all subjects enrolled in these studies were previous failures on conventional approved drug treatments. Data was available for 63% of the patients from the initial studies. Overall, 58% of the men in the new outcome study treated with NX-1207 reported no subsequent surgical treatment and no current drug treatment for their BPH and had an ongoing mean improvement of 11.7 points in AUA BPH Symptom Score 7 ½ years after a single treatment with NX-1207. In addition, 38% of the patients treated with NX-1207 reported no prolonged use of any approved treatments at any time for their BPH since their original treatment with NX-1207, with a mean improvement of 13.7 points. There were no indications of any drug safety issues in any of the patients.
The Company has successfully reported four U.S. clinical trials of NX-1207 and conducted a series of long term follow-up studies of available subjects from those trials in order to monitor and assess long term safety and efficacy of NX-1207 treatment for BPH. The follow-up trials to date have provided further confirmation of the excellent safety and side effect profile of NX-1207 and evidence of enduring benefit for a significant percentage of patients treated with NX-1207.
This sustained improvement in AUA BPH symptom score after NX-1207 treatment compares favorably to the 3 to 5 points reported in published studies of currently approved BPH drugs, which, unlike NX-1207 treatment, require permanent daily administration to be effective. Currently approved drugs also have undesirable side effects such as loss of libido, impotence, retrograde ejaculation, dizziness, and other problems.
NX-1207 has entered its Phase 3 development program, the last stage before filing with the FDA for approval. NX- 1207 is injected by a urologist in an office setting and involves little or no pain or discomfort. For more information about the NX-1207 Phase 3 clinical trials please go to www.clinicaltrials.gov or contact Nymox at firstname.lastname@example.org.
BPH treatment represents a growing market with more than 100 million men worldwide being estimated to suffer from BPH symptoms. The disorder is a common affliction of older men, affecting approximately half of men over age 50 and close to 90% of men by age 80, and is associated with growth in prostate size as men age. BPH causes difficulties with urination associated with aging, such as urination at night, urge to void frequently, hesitancy, weak stream, and other problems.
More information about Nymox is available at www.nymox.com, email: email@example.com, or 800-936-9669.
This press release contains certain “forward-looking statements” as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management’s current expectations. Such factors are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities.
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Posted: March 2011