Nymox Pharmaceutical Announces Positive Prostate Cancer 8 Month Clinical Trial Results
HASBROUCK HEIGHTS, N.J., Sept. 10, 2014 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (Nasdaq:NYMX) announced today new positive outcome results from the Company's ongoing prospective NX03-0040 trial of NX-1207 for the treatment of low grade localized prostate cancer. Clinical outcomes were determined at 8 months from the initial treatments. A controlled comparison was conducted of patients who required and received radiation and surgery treatments for their cancer based on blinded post-treatment upgraded evaluations of their pre-treatment initially positive lower grade cancers. The study found after 8 months for NX-1207 single-injection treated patients that there was a statistically significant reduction compared to controls of more than 75% (p=.002) in the proportion of patients who had upgraded blinded biopsy and laboratory results and went on to require and receive radiation therapy and/or surgery. The new results also indicated that the NX-1207 treated patients had 67% less progression to surgery and/or radiotherapy compared to controls (p=.008) for all reasons (including elective surgery and/or radiotherapy with no biopsy or laboratory upgrades).
146 patients were enrolled in the NX03-0040 Phase 2 U.S. trial and either randomized to one of two doses of NX-1207 (2.5 mg or 15 mg) or to active surveillance. The drug was injected into the area of the prostate where the cancer was detected and repeat biopsies were then performed on all patients, drug treated and controls. The patients in the active surveillance group in the study who were eligible could elect crossover drug treatment after their first follow-up rebiopsy. Follow-up studies are being conducted of all consenting patients in the study to continue to monitor outcome and safety data.
These new findings extend the previously reported study results which showed that patients with NX-1207 treatment after 2 months had less clinical progression and significantly less Gleason grade progression, lower average PSA levels, lower numbers of biopsy cores showing greater malignancy, and lower total volume of more malignant cancer compared to controls.
To date, NX-1207 has had an excellent safety profile as both a treatment for benign prostatic hyperplasia (BPH) and localized low-risk prostate cancer. In the current trial, a new high dose of drug (15 mg) was safely used without drug-related adverse effects. NX-1207 has shown safety in repeat injection studies (NX02-0020 and NX02-0022). The drug does not lead to immune responses such as antibody formation which can cause significant drug toxicity and/or limit usage to single treatments due to drug neutralizing effects.
Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. An estimated 233,000 cases will be newly diagnosed in the U.S. in 2014 with approximately 50% of them being initially considered low risk.
NX-1207 is in Phase 3 development in the US and Europe for benign prostatic hyperplasia (BPH) also referred to as prostate enlargement, a common condition of middle-aged and elderly men affecting up to half of men over the age of 50. The Company's European partner for BPH is Recordati S.p.A.
More information about Nymox is available at www.nymox.com, email: info@nymox.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. Development of drug products involves substantial risks and actual results may differ materially from expectations. Factors that could cause actual results or events to differ materially from those projected in forward-looking statements are detailed from time to time in Nymox's filings with the United States Securities and Exchange Commission and other regulatory authorities."
CONTACT: For Further Information Contact: Brian Doyle Nymox Pharmaceutical Corporation 1-800-93NYMOX www.nymox.com