Bexion Pharmaceuticals Receives Study May Proceed Letter from FDA for a Phase 1b/2 Clinical Trial of BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma
FOR IMMEDIATE RELEASE Covington, KY, 29 September 2021
Bexion Pharmaceuticals, Inc. announced today 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.
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.”
About Bexion Pharmaceuticals
Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is pioneering the development of life-changing treatments by leveraging the untapped mechanisms of the lysosome. Bexion believes the lysosome is an underexploited cellular orchestrator involved in multiple diseases. Bexion’s lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, lysosomal activator protein, Saposin C and a phosphatidylserine.
BXQ-350 has demonstrated pre-clinical antitumor effects in vitro and in vivo, particularly in brain and other solid tumors, including those that may lead to brain metastases. Bexion has completed a multi-site first-in-human Phase 1 clinical trial of BXQ-350 for solid tumors and gliomas. Bexion is in Phase 1 for a rare pediatric brain tumor and plans to initiate two adult Phase 2 programs in 2021-2022.
Media Contact: Margaret van Gilse ●859.757.1652 ● [email protected].
Forward-Looking Statements
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