On September 29, 2021 Bexion Pharmaceuticals, Inc. reported that a Study May Proceed letter has been received from the US Food and Drug Administration (FDA) for the Investigational New Drug Application (IND) for BXQ-350 to initiate a Phase 1b/2 clinical trial in newly diagnosed stage 4 metastatic colorectal cancer patients (Press release, Bexion, SEP 29, 2021, View Source [SID1234590489]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bexion recently completed Phase 1 studies in both adults and children with advanced solid tumors utilizing BXQ-350 as monotherapy. These studies demonstrated that BXQ-350 has a tolerable safety profile with no dose limiting toxicity (DLT) at the highest administered dose and showed in some patients preliminary evidence of anti-tumor activity (including in advanced colorectal cancers).

Additional pre-clinical and anecdotal data suggest that BXQ-350 may play a role in decreasing oxaliplatin-induced sensory neurotoxicity, a common result of colorectal cancer standard of care.

"BXQ-350 with its proven safety profile, potential efficacy and possible neuropathy benefit makes it a worthwhile candidate to use in combination with standard of care treatment for metastatic colorectal cancer (mCRC), stated Dr. Ray Takigiku, CEO and President of Bexion. "We are hoping to not only enhance the standard treatment of mCRC, but to potentially alleviate the side effects related to oxaliplatin-induced sensory neurotoxicity."