The promising potential of Bexion Pharmaceuticals' ground-breaking product, known as SapC-DOPS, received further endorsement recently when it was announced that the Covington-based company has been selected by the National Cancer Institute (NCI) for a research collaboration and in-depth study of their innovative technology.
Bexion's cancer-fighting therapeutic has demonstrated specific tumor-targeting activity based on its preferential affinity for certain components commonly found in the membranes of many tumor cells. Initial studies of SapC-DOPS have shown that the product "induces apoptosis (cell death) of the tumor cells while sparing normal cells and tissues," explains Bexion President and CEO Ray Takigiku.
Dr. Takigiku credits the discovery of SapC-DOPS to Dr. Xiaoyang Qi, now Associate Research Professor in Human Genetics at Cincinnati Children's Hospital Research Foundation, who recognized the tumor-fighting capability of the therapeutic during the course of a genetic disorder study.
Qi's work caught the attention of Dr.Kevin Xu, VP of Global Operations for Bexion, who brought it to the attention of Takigiku, for whom he once worked at P&G Pharmaceuticals. Recognizing the potential of SapC-DOPS, the pair obtained licensure for the platform technology from Cincinnati Children's Hospital and launched Bexion Pharmaceuticals in 2006 in order to continue research and development of the therapeutic.
"SapC-DOPS has shown efficacy against glioblastomas and pancreatic cancers and is something brand new -unlike any other type of therapeutic in anyone's pipeline right now," explains Takigiku. The CEO also admits that the unique nature of the product and its non-traditional discovery can make for regulatory challenges in what is already a long, involved, and expensive process in bringing a new therapeutic into the clinic.
Bexion's collaboration with the NCI, who have "seen the results and are excited by them," will be instrumental in navigating these regulatory channels and expediting the preclinical development phases necessary prior to commercialization of the product.
The initial efforts of the NCI's Nanotechnology Characterization Laboratory (NCL) will focus on acquiring essential data to build a detailed profile of Bexion's therapeutic. The data generated will then be used to support the company's initial filing with the U. S. Food and Drug Administration (FDA) for approval as an Investigational New Drug (IND).
This critical first step, which Bexion management anticipates will take place by the second quarter of 2011, would then open the door for SapC-DOPS to enter clinical trials.
While admitting that "we are early in our gestational period and clinical trials themselves can take years," Takigiku says that the pioneering young company is "focused on getting SapC-DOPS out as an anti-cancer therapy for those in need" and both excited and hopeful about the journey ahead.
Source: Ray Takigiku, PhD, President and CEO- Bexion Pharmaceuticals
Writer: Alyce Vilines