Cumberland Pharmaceuticals (CPIX) and Vanderbilt Health reported positive phase 2a results for ifetroban in patients with high-risk solid tumors, with the study meeting its primary endpoint for safety and tolerability, the companies said Tuesday.
The randomized placebo-controlled trial evaluated ifetroban in patients at high risk for early metastatic recurrence across multiple cancer types, including breast, lung, pancreatic, soft tissue, bladder, and renal cancers, the companies said.
Distant metastatic recurrence occurred in 17% of patients treated with ifetroban, compared with 50% in the placebo arm, while three deaths linked to metastatic disease were reported in the placebo group and none in the ifetroban group, Cumberland Pharmaceuticals and Vanderbilt Health said.
Treatment-related adverse event rates were similar between both groups, with no serious treatment-related adverse events identified, the companies said.
Shares of Cumberland Pharmaceuticals were 2% lower in early Tuesday trading.
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