On November 18, 2024 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN), reported completion of enrollment in the open label portion of Phase 1b/2 ASIST study of BXQ-350 in combination with Standard-of-Care (SOC) for the first line treatment of metastatic colorectal cancer (mCRC) (Press release, Bexion, NOV 18, 2024, View Source [SID1234648486]).
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"I am delighted that Bexion has completed enrollment for its Phase 1b/2 clinical trial and am especially pleased my clinical site has made significant contributions toward this effort," said Reema A. Patel, MD, Associate Professor of Medicine at the Markey Cancer Center of the University of Kentucky. "BXQ-350’s mechanism of action lends itself to potential benefit in metastatic colorectal patients and peripheral neuropathy. Severe neuropathy is a key reason that patients drop off chemotherapy for colorectal cancer, and BXQ-350 has been shown to possess potential anti-neuropathy properties. I am excited by the potential of BXQ-350 to reduce or even potentially reverse neuropathic pain in these patients."
The ASIST study will assess the safety and efficacy of BXQ-350 plus SOC, modified FOLFOX7 (mFOLFOX7) and bevacizumab, in patients with newly diagnosed mCRC. The study is also evaluating whether the administration of BXQ-350 with mFOLFOX7 and bevacizumab may diminish CIPN, enabling participants to receive the total and planned doses of mFOLFOX7.
"We extend our gratitude to all the patients, clinical investigators, and site research staff who continue to contribute to the advances we are making," said Jim Beach, Chief Executive Officer of Bexion. "We are excited about advancing to the next stage of clinical development, including further discussions with FDA on study design, and we look forward to providing updates as we reach upcoming milestones in 2025."
More information about the clinical trial is available at clinicaltrials.gov (ASIST study; NCT05322590).
About BXQ-350
Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional sphingolipid activator protein, Saposin C, and a phospholipid. Multiple Phase 1 clinical trials in adult and pediatric patients have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in patients treated with oxaliplatin and other chemotoxic agents.