Nymox Pharmaceutical Corp. recently announced the 18-month results from its 40-month Phase 2 clinical trial (NX03-0040) of fexapotide triflutate (NX-1207) in localized prostate cancer. The results revealed the study endpoints were met and that cancer progression was improved in the groups of patients who were treated with fexapotide.
NX-1207 is a novel drug that can be 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. The trial that began in February 2013 at 28 clinical sites in the U.S. was designed to evaluate the safety and efficacy of a single injection of NX-1207 for the treatment of biopsy-confirmed low-risk localized (T1c) prostate cancer in 147 patients currently undergoing active surveillance.
Study participants were randomized either to treatment with a single intraprostatic injection of NX-1207 (2.5 mg. or 15 mg.) followed by active surveillance, or to no treatment (continued active surveillance).
Results of the 18-month clinical outcomes of a single injection of fexapotide included:
- Undetectable cancer post-treatment in the region of the prostate where the baseline cancer was detected;
- Reduction of 75.5 percent in biopsy-proven prostate cancer Gleason upgrades in patients treated with fexapotide 15 mg. compared to control; reduction of 71.7 percent in prostate cancer Gleason upgrades in patients treated with fexapotide compared to controls;
- A reduction of 84.8 percent in surgery or radiotherapy instituted for prostate cancer Gleason upgrade in patients treated with fexapotide compared to controls;
- A reduction of 54.8 percent in surgery or radiotherapy instituted for all causes with or without prostate cancer Gleason upgrade in patients treated with fexapotide 15 mg. compared to controls;
- Significant improvement for patients treated with fexapotide compared to controls in all the trail secondary endpoints, which included change in tumor grade in the region of the baseline prostate cancer; change in tumor volume in the region of the baseline prostate cancer; change in tumor grade for the whole prostate; and change in tumor volume in the whole prostate;
- No observed drug-related adverse events and no sexual adverse events;
- Overall superior results for the fexapotide 15 mg. dose compared to the 2.5 mg. dose (dose-response).
“These results demonstrate that a single targeted office injection of fexapotide has led to statistically significant improvement in outcomes with much less surgery or radiotherapy required after 18 months. This means a reduction in patient discomfort, and a reduction in permanent side effects and life changes when the more invasive treatments are required,” Paul Averback, Nymox’s CEO, said in a press release.
“Based on these outcomes, we believe there are exciting potential patient benefits from one or more painless fexapotide office injections for this common and distressing condition,” Averback said.