Epeius Biotechnologies announced today the results of Phase I/II and II studies of Rexin-G in chemotherapy-resistant metastatic soft tissue sarcoma and osteosarcoma, as presented by Dr. Sant P. Chawla, principal investigator, at the CTOS 14th annual meetings held in London UK on November 13-15, 2008.
Patients received repeated infusions of Rexin-G i.v. over a period up to 9 months. Analysis of safety and efficacy data showed no major toxicity, while documenting significant control of tumor growth.
Analysis of efficacy in 42 patients with bone and soft tissue sarcoma showed a dose-response relationship between overall survival and Rexin-G which was highly significant. A confirmatory Phase II study in 17 osteosarcoma patients showed a median overall survival greater than seven months; that is, after failing standard chemotherapies. Two patients are disease-free greater than 6 months after surgical resection of residual tumors and Rexin-G given as both neoadjuvant and adjuvant monotherapy. These studies indicate that (i) intravenous Rexin-G is safe and well-tolerated, and (ii) Rexin-G controls tumor growth and improves survival in a dose-dependent manner in patients with chemotherapy-resistant metastatic soft tissue sarcoma and osteosarcoma.