Epeius Biotechnologies Corporation Advanced Phase I and Phase II Studies of Targeted Gene Delivery Confirm That Rexin-G Impacts Survival in Chemotherapy-resistant Bone and Soft Tissue Sarcoma
STUDY SUMMARY: The goals of the study were to evaluate the over-all safety and efficacy of intravenous infusions of Rexin-G, a tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, in chemo-therapy-resistant bone and soft tissue sarcoma. A Phase II "run-in" component was integrated by adaptive design by continuing treatment if the patient had Grade 1 or less toxicity. Thirty-six patients received escalating doses of Rexin-G intravenously three times a week for four weeks. Analysis of safety showed no dose-limiting toxicity and no cumulative toxicity in patients treated with Rexin-G monotherapy for up to 2 years. Analysis of efficacy revealed a dose-dependent relationship between progression-free survival/overall survival and Rexin-G dosage (p = 0.02 and 0.002 respectively) which was significant at the 5% statistical level by the log-rank test. Median survival was 11.5 months and one-year survival was 40% in the high-dose groups. These findings indicate that intravenous Rexin-G is safe and well-tolerated with no cumulative toxicity, and that Rexin-G controls tumor growth, and prolongs progression-free survival and over-all survival times in a dose-dependent manner in patients with chemotherapy resistant bone and soft tissue sarcoma.
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.
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SOURCE Epeius Biotechnologies