Nymox Pharmaceutical Corp. has announced that its long-term extension prospective double-blind Phase 3 clinical trials of fexapotide triflutate (NX-1207) as a single-injection treatment in benign prostatic hyperplasia (BPH) patients have met their primary endpoint of sustained and statistically significant benefit.
The trials, NX02-0017 and NX02-0018, were multicenter, placebo-controlled and double-blind evaluations of the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH versus placebo. The two U.S. trials enrolled a total of 978 BHP patients, and also found that fexapotide triflutate demonstrated an excellent safety profile with no indication of drug-related short-term or long-term toxicity, as well as no significant and treatment-related molecular side effects.
The primary endpoint was improvement in the AUA BPH Symptom Score (I-PSS) at a median of 3.5 years following a single injection of NX-1207 versus placebo, and statistically significant improvement was found. Patients were followed for at least two years after single treatment and for up to 5.4 years.
Results from the Phase 3 extension trials were:
- Statistically significant mean improvement of 5.3 points in I-PSS at median duration (3.5 years) after a single-injection treatment versus saline placebo.
- Mean improvement of 7.1 points in I-PSS at 3.5 years in BPH patients who were treated with fexapotide as first-line therapy.
- Statistically significant higher proportion (64%) of long-term patients with improved I-PSS following single-injection fexapotide treatment versus controls.
- Compared to placebo, the percentage of patients who improved or stabilized nocturia was superior in those treated with fexapotide.
Nymox also reported that trial participants treated with one or two injections of fexapotide had, within 24 months, a statistically significant reduction in the need for BPH surgery compared to patients in the placebo group.
The results also showed the drug has a safety profile superior to current available treatments, with a low incidence of cardiovascular, sexual or hormonal side effects. In addition, data from a Phase 2 study on low-grade and localized prostate cancer patients demonstrated statistically significant less disease progression in the treatment group versus controls, the company reported. Fexapotide has also shown enhanced compliance and patient convenience compared to oral medications.
Nymox plans to file regulatory approval requests for fexapotide triflutate with relevant authorities.