FOR IMMEDIATE RELEASE [Covington, KY ~ September 5, 2017]
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.
“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.
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.
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 at CTI. “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.”
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).
About Bexion Pharmaceuticals
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
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hematology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Bexion’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Bexion has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Bexion’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; the fact that Bexion’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. You should not place undue reliance on any forward-looking statements. Bexion undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.