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news.Nymox Pharmaceutical has begun the Phase 2 US clinical trial to investigate its NX-1207 drug as a treatment for low grade localized prostate cancer.
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The two-dose six week Phase 2 study will enroll 150 men to evaluate the effect of both low and high doses of NX-1207 on low grade localized prostate cancer.
The trial is designed in accordance with specific direction and guidance provided by the US Food and Drug Administration (FDA).
Currently, NX-1207 is in Phase 3 development in the US and Europe for the treatment of benign prostatic hyperplasia (BPH).
Earlier preclinical studies of NX-1207 have shown activity against prostate cancer cells at higher dosage levels of NX-1207 than the dosage used in the current Phase 3 BPH clinical trials.
Nymox CEO Paul Averback said the drug’s safety profile and ease of administration make NX-1207 a potential treatment for men with low grade prostate cancer.
The company has filed a new Investigational New Drug (IND) application for NX-1207 with the FDA.