HASBROUCK HEIGHTS, N.J.—Nymox Pharmaceutical Corp., a company specializing in research and development of therapeutics and diagnostics, particularly for unmet needs in aging populations, has released positive outcome results from its ongoing NX03-0040 trial of NX-1207. The compound is currently being developed as a treatment for low-grade localized prostate cancer. NX-1207 is also in Phase 3 development in the United States and Europe as a treatment for benign prostatic hyperplasia (BPH), also known as prostate enlargement, a common condition that affects up to half of men over the age of 50. Recordati S.p.A. is Nymox’s European partner in this indication.
The NX03-0040 Phase 2 U.S. trial consists of 146 patients randomized to either 2.5 mg of NX-1207, 15 mg of NX-1207 or active surveillance. Those patients in the active surveillance group who were eligible could choose crossover drug treatment after their first follow-up rebiopsy.
A controlled comparison was conducted of patients who needed and received radiation and surgery treatments for their cancer based on blinded post-treatment upgraded evaluations of their pretreatment initially positive lower-grade cancers. After eight months for patients who received a single injection of NX-1207, there was a statistically significant reduction compared to controls of more than 75 percent in the patients who had upgraded blinded biopsy and laboratory results and went on to require and receive radiation therapy and/or surgery. In addition, the study reveal that the patients who received NX-1207 had 67 percent less progression to surgery and/or radiotherapy compared to controls.
So far, the drug has presented with an encouraging safety profile, both as a treatment for BPH and as a treatment for localized low-risk prostate cancer. In this current trial, the highest dose of NX-1207 (15 mg) was administered without drug-related adverse effects, and the drug has proved safe in repeat injection studies NX02-0020 and NX02-0022. In addition, administration of NX-1207 does not lead to immune responses such as antibody formation, which can lead to significant drug toxicity.
“In two multicenter Phase 2 U.S. prospective randomized blinded clinical trials, the aggregated mean improvement in the primary endpoint of BPH Symptom Score for 2.5 mg NX-1207 was 10.3 points, which is about double the reported degree of improvement for approved BPH drugs,” Nymox notes on its website. The company also reports that the results of six follow-up studies of available subjects from NX-1207 trials have shown “evidence of durable benefits from NX-1207 treatment for up to six-and-a-half years from the date of a single treatment.”
These results echo those of previous studies demonstrating that patients treated with NX-1207, after two months, presented with less clinical progression, 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.
In July, Nymox announced positive new efficacy data from its NX02-0022 U.S. study, which is a repeat injection study of NX-1207 for BPH. Over the course of a one- to two-year period, patients showed a mean improvement of 8.2 points in the AUA BPH Symptom Index Score. In addition, safety data confirmed that repeat injection treatment is well tolerated by patients, with no drug-related significant side effects.
As Nymox notes on its website: “NX-1207 is a novel drug … administered by a urologist in an office procedure that takes a few minutes, does not require any type of anesthesia or catheterization, and involves little or no pain or discomfort.”
Prostate cancer is the most common cancer in men and the second leading cause of cancer death for men (behind lung cancer). The National Cancer Institute of the National Institutes of Health predicts that 233,000 new cases of prostate cancer will be diagnosed in the United States this year, with some 29,480 deaths. Of the new cases, roughly 50 percent of them are expected to be considered low risk initially.