The Phase II Prostate Cancer study demonstrated that oral SM-88 (racemetyrosine) was associated with disease control while maintaining QOL; More than 450,000 of these patient cases annually in U.S. alone
Based on study results, SM-88 may have a clinically meaningful role in postponing medical castration in prostate cancer patients with rising prostate-specific antigen (PSA)
At 6 months, 100% of patients (23/23) were free of metastatic progression (MFS), and 87% of patients (20/23) remained free of any radiographic progression (rPFS)
After 12 weeks, 78% of patients (18/23) demonstrated a 65% decrease in median CTCs from baseline
52% of patients (12/23) showed improvement in median PSA doubling time (DT)
No drug-related severe or life-threatening adverse events (grade 3 or 4) were observed after cumulative dosing exposure of 149 months
TYME is evaluating regulatory strategies in the interest of advancing SM-88 for patients with non-metastatic recurrent prostate cancer
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