Salarius Pharmaceuticals announces U.S. Food and Drug Administration, FDA, clearance of the company’s investigational new drug, IND application to commence a Phase 1 clinical trial with SP-3164 in patients with relapsed/refractory non-Hodgkin lymphoma. Salarius expects to begin treating patients in the dose-escalation portion of the trial in the second half of 2023 to evaluate safety, clinical activity, pharmacokinetics and pharmacodynamics. “FDA clearance of the SP-3164 IND marks another significant milestone for Salarius and demonstrates our continued focus and commitment to bringing new therapies to patients in need of new treatment options,” said David Arthur, president and chief executive officer of Salarius, “We now plan to enroll NHL patients in the dose-escalation portion of the clinical trial and will then focus on patients with diffuse large B-cell lymphoma in the second portion of the trial.”
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