SAN MARINO, Calif. — Epeius Biotechnologies (www.epeiusbiotech.com) confirms the first real breakthrough for pancreatic cancer seen in years; publishes a landmark report of tumor-targeted Rexin-G as stand-alone therapy in chemotherapy-resistant pancreatic cancer. Following Phase I studies at the Mayo Clinic, which affirmed the general safety of Rexin-G, advanced U.S. Phase I/II studies were undertaken, which included a Phase II efficacy component and examined progressive dose escalations of Rexin-G, while monitoring objective tumor responses in a comprehensive manner.
Employing these higher doses of Rexin-G led to improved tumor responses, as assessed by all available measures (RECIST, Intl. PET and CHOI criteria) and nearly tripled the expected survival time, all in a dose-dependent manner. Moreover, this U.S. study serves to establish a critical pharmacological threshold of bioactivity, for this otherwise intractable disease, by demonstrating an increase in overall survival time (measured as percent surviving 12 months) from virtually nil using low doses to more than 28 percent of the patients using high doses surviving beyond one year.
By meeting all primary and secondary study endpoints of safety and efficacy, Epeius Biotechnologies’ Rexin-G has succeeded in an area of clinical oncology where many promising biologics have simply failed to deliver. By achieving both progression-free survival and overall survival benefits in pancreas cancer, while avoiding untoward systemic or dose-limiting toxicities, Rexin-G has raised the bar for the entire biopharmaceutical industry, as it inaugurates the emerging field of precision-targeted genetic medicine.
The outstanding results of this advanced U.S. clinical trial confirm the results of previous preclinical and clinical studies conducted in the Philippines (where Rexin-G is approved for all solid tumors), and demonstrate beyond contestation that Rexin-G, at these effective dose levels, exhibits profound anti-tumor activity when administered as a single therapeutic agent in otherwise intractable Stage IV pancreatic cancer.
The success of these landmark studies is a tribute, not only to the clinical investigators who “held the course” and the “cause” of a better medicine as a high standard, but to the U.S. FDA who, by allowing across-the-board dose escalations in ongoing trials for sarcoma, breast, and pancreas cancer (once general safety was established), served to expedite the achievement of these effective doses, and thus these heartening results. The full article, authored by Dr. Sant P. Chawla et al., is now available online (Molecular Therapy, Oct 13, 2009; see Advance Online Publications: www.nature.com/mt/ ).
About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its lead products, Rexin-G and Reximmune-C, and its high-performance gene delivery systems.
To learn more about these agents and/or ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com, or visit: www.epeiusbiotech.com.
