Covington-based Bexion Pharmaceuticals, Inc., a clinical stage oncology company, has announced the initiation of an open-label Phase 1 Safety Study of BXQ-350.
The first U.S. site is Cincinnati Children’s Hospital Medical Center.
This clinical trial will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in the pediatric population with recurrent solid tumors, brain tumors and diffuse intrinsic pontine gliomas (DIPG).
In a Phase 1 Part 1 Adult Dose Ranging Study, BXQ-350 was well tolerated at all five doses tested with no dose-limiting toxicities observed and no serious adverse events attributed to the therapy.
Preliminary data in Part 2 of the Phase 1 support a safe and tolerable drug profile. Information about the Phase 1 Study of BXQ-350 in Adult Patients with Advanced Solid Tumors trial can be found here.
In December 2018, the FDA cleared a Phase I Pediatric Protocol as part of Bexion’s current IND to move BXQ-350 into the pediatric population.
Dr. Takigiku
“With this initiation of Pediatric Phase 1 studies, we are confirming our commitment to the pediatric patient community,” said Dr. Ray Takigiku, Founder and CEO of Bexion. “It is our goal to develop BXQ- 350 as quickly as possible for both adult and pediatric cancer patients, particularly those with difficult to treat tumors including high grade gliomas and other brain tumors. We are very grateful to the patients, participating clinical trial sites, and our partners for their engagement and their support.”
The technology supporting BXQ-350 was discovered more than 15 years ago by Dr. Xiaoyang Qi, a then-faculty member at Cincinnati Children’s. CancerFree KIDS, a non-profit focused on eradicating cancer a life- threatening disease in children, provided the first grant that supported this discovery.
Cincinnati Children’s licensed the technology to Bexion to continue development and ultimately commercialize the discovery.
“The very first research grant CancerFree KIDS ever awarded was to Dr. Qi in 2004”, explained Ellen Flannery, Founder and Executive Director of CancerFree KIDS. “It was for the study that eventually led to the formation of Bexion Pharmaceuticals. We have followed this research and Bexion since that time, waiting for this pivotal moment of the initiation of a Pediatric Phase I trial. It is rare for a pediatric trial to happen so early in the development of a new treatment.”
The mission of CancerFree KIDS is to eradicate cancer as a life-threatening disease in children by funding promising research that might otherwise go unfunded. CancerFree KIDS was founded by Ellen and Sam Flannery after their baby daughter was diagnosed with cancer in both of her eyes at 5 months of age. Today, thanks to cancer research, that baby is a healthy college student. CancerFree KIDS funds childhood cancer research.
“CancerFree KIDS is grateful to Bexion, Cincinnati Children’s and CTI Clinical Trial and Consulting Services, Bexion’s Clinical Research Organization for initiating this trial as quickly as feasibly possible,” said Flannery. “This means we have an opportunity to get this extremely promising new treatment approved for the children who need it as quickly as possible.”
Additional sites are planned, including Nationwide Children’s Hospital in Columbus, Ohio and several children’s hospitals in the western United States.
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 multi-site first-in-human Phase 1 Parts 1 and 2 clinical studies of BXQ-350 for solid tumors and gliomas. A Phase 1 Part 3 expansion phase study is currently enrolling patients.
For more information, click here.
Bexion Pharmaceuticals
