NKyTribune staff
Covington-based Bexion Pharmaceuticals, Inc. an oncology-focused company, has announced the completion of a Type B Pre-IND in-person meeting with the U.S. Food and Drug Administration (FDA) to discuss the design of a Phase 1 pediatric clinical trial for BXQ-350.
BXQ-350 is the Bexion’s lead candidate, for the treatment of rare pediatric disease, Diffuse Intrinsic Pontine Glioma (DIPG)/ Diffuse Midline Glioma (DMG).
Bexion Pharmaceuticals is a clinical-stage biopharmaceutical company developing BXQ-350, a first-in-class agent composed of the multifunctional, lysosomal activator protein Saposin C and phosphatidylserine.
As part of the overall Regulatory Strategy, Bexion had previously filed for and was awarded a formal Pediatric Rare Disease Designation for BXQ-350, in June 2019. This designation represents candidacy of BXQ-350 for a future Pediatric Rare Disease Voucher for DIPG.
Dr. Takigiku
“This Type B meeting outcome now represents agreement with FDA on several points, allowing for a clearer and streamlined development path forward,” stated Dr. Ray Takigiku, Founder and CEO. “This will benefit Bexion as it pursues development of this indication, as one important application in the BXQ-350 oncology platform.”
An earlier clinical trial of BXQ-350 at the University of Kentucky Markey Cancer Center’s Precision Medicine Clinic showed promising results.
Tollesboro resident Jenn Highfield called the results from the treatment she received in that trial “miraculous.”
To learn more about the clinical trial, and Highfield’s story, click here.
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. A Phase 1 Pediatric Trial opened in April, 2019.
