News & Events CTI Congratulates Bexion Pharmaceuticals on Presentation of Clinical Data at 2018 ASCO Annual Meeting

CTI Congratulates Bexion Pharmaceuticals on Presentation of Clinical Data at 2018 ASCO Annual Meeting

May 22, 2018

FOR IMMEDIATE RELEASE [Covington, KY ~ [May 22, 2018CTI Clinical Trial and Consulting Services (CTI), a multi-national, privately held, full-service contract research organization, congratulates its partners at Bexion Pharmaceuticals, Inc. on the presentation of clinical data at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting to be held June 1-5 in Chicago, IL.

CTI and Bexion, a clinical-stage biopharmaceutical company focused on rare brain and solid tumors, first announced their partnership in the development of BXQ-350 for the treatment of cancer in the fall of 2016.


Bexion’s representation at ASCO:

Abstract # 2517: First-in-class Phase Ia Study of BXQ-350 for Solid Tumors and Gliomas

Olivier Rixe, MD, PhD, will participate in a Q&A panel presenting data from this study during a Poster Discussion Session on Monday 4 June 2018 from 3:00-4:15 pm. Dr. Rixe’s comments will include that BXQ-350 met its Phase I Safety endpoint with no significant DLT or SAE attributed to drug at the highest planned dose. In addition, it was observed that BXQ-350 showed promising clinical activity in heavily pre-treated patients with recurrent brain cancer and advanced solid tumors.

The following three abstracts will be included online in the 2018 ASCO Annual Meeting Proceedings, a Journal of Clinical Oncology supplement, publicly released on May 16, 2018.

Absence of Indicators of Hypercoagulability and Anti-Phospholipid Syndrome in BXQ-350 First in Human Study
Therapeutic BXQ-350 nanovesicles, comprised of a lysosomal activator protein and a phosphor- lipid, did not cause anti-phospholipid syndrome (APS) or clinically significant hypercoagulability in humans.

Allometric Scaling of Preclinical Pharmacokinetic and Toxicokinetic Parameters to Predict Clinical Pharmacokinetics of BXQ-350 Saposin C Protein-Phosphatidylserine Nanovesicles 
Allometric scaling of animal PK/TK data provided reasonable estimates of human PK and exposure for BXQ-350 and can be expected to have good predictive utility for extrapolating drug dose and pharmacokinetic parameters.

Combined Effect of Gemcitabine (GEM) and SapC-DOPS Nanovesicles on Pancreatic Ductal Adenocarcinoma (PDAC) in Mice
The combination of Gemcitabine and SapC-DOPS demonstrated enhanced antitumor activity in Pancreatic Ductal Adenocarcinoma (PDAC) in mice.

“These abstracts highlight the excitement we have on the potential of BXQ-350 to treat brain and multiple solid tumors; and potentially opening new avenues to treat CNS tumors” stated Dr. Ray Takigiku, Founder and CEO of Bexion.

“The University of New Mexico Comprehensive Cancer Center is pleased to take part in these Phase 1A clinical trials,” said Rixe, who is the Principal Investigator at that site and author of the Phase I protocol. “I am honored to present the preliminary results to the scientific community on Bexion’s BXQ-350 and share these exciting new developments.”

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, hepatology, 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

About BXQ-350 

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. Currently Bexion is in a Series B Fund Raise. For more information, visit www.bexionpharma.com..

About Olivier Rixe, MD, PhD

Olivier Rixe, MD, PhD, is a Professor in the Department of Internal Medicine, Division of Hematology/Oncology, at the University of New Mexico School of Medicine. He serves as the Associate Director for Clinical Research at the UNM Cancer Center. Trained as a medical oncologist, Dr. Rixe is internationally renowned for his work in Phase I clinical trials and as Principal Investigator for several neuro-oncology clinical trials. He was involved in the early development phases of many U.S. Food and Drug Administration approved agents, including oxaliplatin, camptothecins, and taxanes; and many targeted therapies including antiangiogenic compounds sunitinib, axitinib and VEGF-trap.

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