SAN MARINO, Calif. — Epeius Biotechnologies (www.epeiusbiotech.com) today announced the results of two related studies using Rexin-G, a tumor-targeted anti-cancer agent designed to seek-out and destroy metastatic cancers that have spread throughout the body. While Rexin-G is currently approved for the treatment of all solid tumors in the Republic of the Philippines, Epeius Biotech is conducting a series of advanced Phase I/II studies and a Phase II confirmatory trial in the U.S. The Phase I/II study evaluating the safety and efficacy of Rexin-G in chemotherapy-resistant metastatic bone and soft tissue sarcomas (ASCO Annual Meeting 2009, #10513) demonstrated that Rexin-G was well-tolerated with no dose-limiting toxicity.
Moreover, Rexin-G exhibited dose-dependent efficacy in terms of tumor control rates, progression-free survival, and overall survival, thus validating both the efficiency of the tumor-targeting technology and the pharmacological mechanisms of action.
The efficacy and safety of Rexin-G was further confirmed in a Phase II study for chemotherapy-resistant osteosarcoma. Again, in the absence of dose-limiting toxicity, Rexin-G was demonstrated to control tumor growth, prolong progression-free survival, and improve overall survival in osteosarcoma patients who have failed known therapies. It is important to note that these outstanding results, were achieved when Rexin-G was administered as monotherapy-unlike many other so-called targeted biologics where one or more toxic agents are used in combination in order to achieve even marginal results.
Based on a critical analysis of its performance in the clinic, the U.S. FDA recently granted Rexin-G Orphan Drug Status for both soft tissue sarcoma and osteosarcoma. The results of these studies will be presented by Dr. Sant P. Chawla, Sarcoma Oncology Center, Santa Monica CA, and discussed by Dr. Katherine Janeway, Dana-Farber Cancer Institute, Boston MA on Saturday, May 30, 2009 at 5:00 p.m. EST/EDT.
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 high-performance gene delivery systems that are embodied in Rexin-G and Reximmune-C, a tumor-targeted cancer vaccine.
To learn more about ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com, or visit: http://www.epeiusbiotech.com.
