Bexion Pharmaceuticals and CTI Clinical Trial and Consulting Services have successfully completed the First-in-Human Phase 1A clinical trial with BXQ-350 for the treatment of cancer.
This does escalation, open-label study included adult patients with advanced solid tumors.
“We are very excited to have successfully completed this First-in-Human, dose escalation trial and look forward to moving BXQ-350 forward into a larger cohort of patients in the very near future,” stated Dr. Ray Takigiku, Founder and CEO of Bexion.
CTI, an expert in rare diseases and in the development of life-changing therapies in critically ill patients, including patients with cancer, has been a part of several dozen First-In-Human trials over the past few years. The company recently moved its global headquarters to Covington, KY, where CTI’s research team works down the street from Bexion’s corporate headquarters.
“CTI is extremely happy to partner with Bexion on the development of this novel therapy in patients who desperately need alternative treatments,” stated William Aronstein, PhD, MD, FACP, Vice President, Medical Affairs. “They are an innovative organization with very strong regional ties – the drug was initially developed and licensed at a local hospital, early funding has predominantly come from the region, and the management and board have strong local connections.”
Bexion Pharmaceuticals (Bexion) and CTI Clinical Trial and Consulting Services (CTI) announce the successful completion of the First-in-Human Phase IA clinical trial with BXQ-350 for the treatment of cancer. This dose escalation, open-label study included adult patients with advanced solid tumors.
The trial was designed to determine the maximum tolerated dose of BXQ-350 and to characterize its safety and pharmacokinetics. BXQ-350 was well tolerated at all five doses with no dose limiting toxicities observed and with no serious adverse events attributed to the therapy. The highest dose tested will be utilized in the upcoming Phase IB trial.
In pre-clinical animal studies, Bexion’s first-in-class biologic, BXQ-350 has been shown to induce tumor cell death in a variety of cancers. BXQ-350 is a unique formulation of a synthetically produced, human lysosomal protein, Saposin C (sphingolipid activator protein, or SapC), and the phospholipid dioleoylphosphatidylserine (DOPS).
Bexion Pharmaceuticals is a privately-held biotech company focused on the development and commercialization of innovative cures for cancer. Bexion’s first-in-class biologic, BXQ-350, has demonstrated selective tumor targeting with the potential for clinical efficacy in a broad range of cancers. In 2013 the NCI awarded Bexion a prestigious “Bridge Award” of $3MM to support testing of BXQ-350 in the clinic. In February 2015, the FDA granted Bexion Orphan Drug status for Saposin C, the active ingredient in its proprietary drug BXQ-350, for the potential treatment of glioblastoma multiforme (GBM), a type of brain cancer. In June 2015, Bexion won a Tibbett’s Award by the Small Business Administration for exemplifying the very best in innovation. For more information, visit www.bexionpharma.com
