SAN MARINO, Calif., Nov. 5 Epeius BiotechnologiesCorporation announced today that the company has taken a major step toward thecommercialization of its lead product with the opening of a Phase IIRegistration Protocol using Rexin-G for osteosarcoma in the United States.Following the accelerated approval of Rexin-G for the treatment of all solidtumors by the Bureau of Food and Drugs in the Philippines, Epeius opened anumber of Phase I/II clinical trials in the United States for pancreaticcancer, breast cancer and all types of sarcoma in the summer of 2007.
Based on the exceptional safety profile of Rexin-G in the first 18patients who participated in these U.S.-based clinical trials, and theprofound demonstration of single agent efficacy in metastatic osteosarcoma,the FDA approved a Phase II Registration Protocol using intravenous Rexin-Gfor recurrent or metastatic osteosarcoma that is refractory to knowntherapies. The study will recruit 20-30 patients in 12-18 months. Childrenwho are at least 10 years of age or older are eligible to participate in thestudy. The adaptive trial design of this advanced Phase II registrationprotocol incorporates (i) a dosing schedule based on the patient's estimatedtumor burden and not on standard dosing per kilogram body weight or bodysurface area, and (2) a tumor response evaluation process that is unique tothe manner in which osteosarcoma responds favorably to therapy, i.e., withnecrosis and increasing calcification in metastatic tumors and decreasedglucose utilization using PET-CT imaging studies.
Rexin-G is a tumor-targeted gene medicine that seeks out and destroys bothprimary tumor and metastatic cancers that have spread throughout the body.Delivered by simple intravenous infusion, Rexin-G has demonstratedunprecedented single-agent efficacy against a broad spectrum of solid tumorswhere chemotherapy, radiotherapy and other targeted therapies have failed.With more than three years of clinical experience with Rexin-G in anincreasing number of otherwise intractable cancers in the Philippines, Japanand the U.S., we have gained valuable insights into the general safety,optimal dosing parameters, and best treatment regimens that provide thegreatest benefits for the cancer patient without compromising safety.
The on-going clinical trials of Rexin-G are centered in San Marino CA,where Epeius Biotechnologies Corporation has its headquarters, and in SantaMonica CA at the Sarcoma Oncology Center. Dr. Sant P. Chawla, M.D., whotrained at the University of Texas M.D. Anderson Cancer Center, is a renownedexpert on malignant sarcomas, and serves as Principal Investigator (PI) forthese clinical trials.
About Epeius Biotechnologies
Epeius Biotechnologies Corporation is a privately held biopharmaceuticalcompany dedicated to the advancement of genetic medicine with the developmentand commercialization of its proprietary targeted delivery systems. Creditedwith innovations ranging from oncogene discovery, to designer therapeuticgenes, to pathotropic (disease-seeking) targeting, to high-performance vectorengineering, to advanced biopharmaceutical manufacturing and bioprocessdevelopment, Epeius Biotechnologies is well positioned to "launch" itsenabling platform technologies for the benefit of cancer patients worldwide.Rapid advances in clinical drug development provide Epeius with a uniqueopportunity for early revenues from the exportation and sale of its leadproduct to the Philippines and reciprocating Southeast Asian countries-thusdemonstrating the high growth potential of a small biotechnology company whilemaintaining the lowered risk profile of a biopharmaceutical company with ahigh-value, late-stage product.
To learn more about Rexin-G and Epeius' pipeline of proprietary compoundscurrently available for partnership or clinical trials, ple