Nymox Pivotal Phase 3 Fexapotide NX 1207 BPH
Nymox Pivotal Phase 3 Fexapotide (NX 1207) BPH Extension Trial Successfully Meets Primary Endpoint
Primary Endpoint AUA BPH Symptom Score • Single injection results after median 42 months posttreatment (range 24 months to 65 months) • Mean improvement 5. 3 points (p<. 025 vs placebo) • First-line treatment with fexapotide mean improvement 7. 16 points (p<. 02 vs placebo)
BPH Improvement
AUA BPH Symptom Score Patient Responder Rate • Statistically significant higher proportion of long-term improved patients in AUA BPH Symptom Score (primary outcome variable) after a single injection in fexapotide treated subjects (64%) vs controls (p<. 005)
Nocturia • Median 42 months post-single injection treatment • Stabilization or improvement 87% (p<. 03 vs placebo)
Surgery for BPH • 1. 7% in 2 years after 1 -2 injections of fexapotide (p<. 02 vs placebo)
Fexapotide Lowered Cancer Risk • Phase 2 US data showing reduced progression of low grade prostate cancer in fexapotide treated patients • This is in contrast to elevated cancer risk for some approved BPH oral medications
Nymox Fexapotide Advantages • Safe drug with durable efficacy • Office-based 1 -2 minute injection • Single painless injection: no sedation, no anesthesia • No sexual side effects (commonly seen with older approved BPH medications) • No cardiovascular or hormonal side effects (commonly seen with older approved BPH medications) • Decreased cancer risk (Phase 2 data) (vs increased risk seen with older approved BPH medications)
Nymox Fexapotide Safety Profile Superior to BPH approved medications • No sexual or cardiovascular side effects • No hormonal side effects • No increased risk of prostate cancer (decreased risk with fexapotide, Phase 2)
Nymox Fexapotide Efficacy Profile Highly durable effect: • Single painless office injection with long-term benefit • After a single injection with fexapotide, the majority of patients in Phase 3 pivotal studies required no further oral medications or surgery for up to 5. 4 years (median 42 months). • First-line single treatment after 3. 5 years: 7. 16 point mean improvement
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