Preliminary results from an ongoing Phase 2 clinical trial assessing Tyme Technologies' (TYME +3.8%) lead candidate SM-88 in patients with non-metastatic, biochemical-recurrent prostate cancer showed a positive effect. The data are being presented at the ASCO GU Symposium in San Francisco.
92% (n=12/13) of evaluable patients maintained radiographic progression-free survival (rPFS) for a median of 12 months since biochemical recurrence and 10 months since starting SM-88 treatment. All 12 who have maintained rPFS have also shown significant reductions in circulating tumor cells.
85% (n=11/13) experienced stable or rising testosterone levels with no serious (Grade 3) or life-threatening (Grade 4) adverse events.
On the quality-of-life front, 100% (n=13/13) of patients reported stable/improved interest in sex, 62% reported no or resolved hot flashes and 54% rated their overall health as "excellent."
A Phase 2 study in pancreatic cancer will start soon.
SM-88 is a combination therapy that uses a proprietary dysfunctional tyrosine derivative to interrupt the metabolic processes of cancer cells, breaking down their defenses and making them vulnerable to oxidative stress and death.
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