COVINGTON, Ky., July 18, 2016 /PRNewswire/ -- Bexion Pharmaceuticals, LLC ('Bexion") announced today that the U.S. Food and Drug Administration (FDA) cleared Bexion's application to initiate a First-in-Human Phase I clinical trial with BXQ-350 for the treatment of cancer.
This open-label trial will include adult patients with advanced solid tumors (including glioma, a type of brain cancer). The trial is designed to determine the maximum tolerated dose of BXQ-350 and to characterize its safety and pharmacokinetics. In pre-clinical animal studies, BXQ-350 was shown to induce tumor cell death in a variety of cancers, while leaving healthy cells unharmed.
"We are very pleased to begin clinical development of BXQ-350 in patients with cancer," stated Dr. Ray Takigiku, Founder and CEO of Bexion. "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 FDA, patients and our clinical trial partners in progressing this important 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. 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 $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.
Forward-Looking Statements 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.
Margaret van Gilse
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SOURCE Bexion Pharmaceuticals