September 20, 2010
Bexion Pharmaceuticals announced today that it has been selected by the National Cancer Institute (NCI) for a research collaboration to study Bexion’s first-in-class cancer nanotherapy treatment for solid tumors. The research will be conducted by the NCI’s Nanotechnology Characterization Laboratory (NCL), part of a major program, the Alliance for Nanotechnology in Cancer, to advance the medical applications of nanotechnology. The initial NCL efforts will focus on the characterization of Bexion’s product for its absorption, distribution and toxicity properties in both in vitro and in vivo studies.
The intent of these studies is to produce data for Bexion to support its filings with the U.S. Food and Drug Administration (FDA). The cost of these studies is paid for by the NCL. The agreement is part of NCI’s Advanced Technology Partnerships Initiative, which seeks to accelerate the delivery of new products to cancer patients. “We are very excited by this collaboration with NCL, and hope that we will be able to move more quickly into the clinic and commercialization with their help”, said Dr. Ray Takigiku, CEO and President at Bexion Pharmaceuticals. “The primary purpose of this effort is to accomplish the work necessary for an IND (Investigational New Drug application).”
Bexion’s technology is Saposin C- dioleoylphosphatidylserine (dubbed “SapC-DOPS”) and is a first-in-class nanovesicle therapeutic for the treatment of glioblastomas (GBM), pancreatic cancers, and other solid tumors. SapC-DOPS nanovesicles have preferential affinity for phosphatidylserine enriched membrane patches which appear to be common in many types of tumor cells and tumor neovasculature. Bexion’s initial studies of SapC-DOPS have shown that the product induces apoptosis in cancer cell lines and also demonstrated in vivo efficacy in multiple tumor models.
The NCL has developed a series of protocols that produce a detailed characterization profile for many different kinds of nanoparticles with potential medical applications. These characterization profiles ensure that biomedical researchers have precise information about the particles, such as size, morphology, purity, chemical composition and stability, biodistribution, blood contact properties, and other physicochemical and biological properties. These protocols include toxicology tests that have been adopted as standards by ASTM International. Bexion’s product will be tested through the NCL’s assay cascades for generation of data that may be used in support of an FDA IND submission for SapC-DOPS.
About Bexion Pharmaceuticals
Bexion Pharmaceuticals, based in Covington, Kentucky is focused on the development and commercialization of innovative cures for cancer. The first product is a platform technology licensed from Cincinnati Children’s Hospital Medical Center. It is a first-inclass biologic with data-driven potential for treatment of a broad range of human cancers. The active biologic is recombinantly expressed human Saposin C (SapC) bound to the anionic phospholipid, dioleoylphosphatidylserine (DOPS) - SapC-DOPS.
Specifically with this product, the company is interested in first entering the clinic with a glioma cancer indication, possibly simultaneously with a pancreatic cancer indication.
About the Nanotechnology Characterization Laboratory
The National Cancer Institute (NCI) established the Nanotechnology Characterization Laboratory in 2005—in collaboration with the National Institute of Standards and Technology and the U.S. Food and Drug Administration—to perform preclinical efficacy and toxicity testing of nanoparticles. NCL serves as a national resource and knowledge base for all cancer researchers to facilitate the regulatory review of nanotechnologies intended for cancer therapies and diagnostics. NCL, part of NCI’s Alliance for Nanotechnology in Cancer, works to accelerate the transition of basic nanoscale particles and devices into clinical applications.
Frank Blanchard (Contractor)
Director, Public Affairs
National Cancer Institute at Frederick
Post Office Box B
Frederick, Maryland 21702
Phone: (301) 846-1893
Margaret M. van Gilse
VP, Investor Relations
Bexion Pharmaceuticals, LLC
632 Russell Street
Covington, KY 41011
Phone: (513) 833-7065