Cancer Drug Developed by Covington Company Heads to Clinical Trial
A huge milestone in a local company's fight against cancer has been reached.
Covington-based Bexion Pharmaceuticals announced Monday that the United States Food & Drug Administration (FDA) cleared its application to initiate a "First-in_Human Phase I" clinical trial for its BXQ-350, a drug designed to treat cancer.
This open-label trial will include adult patients with advanced solid tumors (including glioma, a type of brain cancer), the company stated in a news release. The trial is designed to determine the maximum tolerated dose of BXQ-350 and to characterize its safety and pharmacokinetics (the branch of pharmacology concerned with the movement of drugs within the body).
In pre-clinical animal studies, BXQ-350 was shown to induce tumor cell death in a variety of cancers, while leaving healthy cells unharmed, the company said.
“We are very pleased to begin clinical development of BXQ-350 in patients with cancer,” said Dr. Ray Takigiku, Founder and CEO of Bexion, in the announcement. “This major milestone validates the many years of tireless work by the Bexion team and its partners and the invaluable support of its investors. We look forward to working with the FDA, patients, and our clinical trial partners in progressing this important trial.”
Information regarding this Phase I Clinical Trial will be posted on www.clinicaltrials.gov in addition to the Bexion website, www.bexionpharma.com, in the coming weeks.
The sites where Bexion's trial will be conducted are:
- University of Cincinnati
- University of New Mexico
- Ohio State University
- University of Kentucky
The first patient will be dosed at the University of Cincinnati in the September-October timeframe.
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. BXQ-350 is a proprietary nanovesicle formulation comprised of 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 $3 million 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.
Photo: Inside the bioLOGIC offices where Bexion operates (RCN file)