SAN MARINO, Calif. /eNewsChannels/ — Epeius Biotechnologies Corporation (www.epeiusbiotech.com) today announces the results of the clinical study entitled “Phase I and II Studies of Intravenous Rexin-G as Monotherapy for Gemcitabine-resistant Metastatic Pancreas Cancer” at the ASCO Annual Meeting on June 6, 2010. The presentation will be discussed by Dr. Howard W. Bruckner, Bruckner Oncology, New York, NY.
STUDY SUMMARY: The goals of the Phase I/II 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 gemcitabine-resistant pancreas cancer. A Phase II “run in” study was integrated by adaptive design wherein additional cycles were given if the patient had Grade 1 or less toxicity. Twenty 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 up to 18 months. Analysis of efficacy in evaluable patients revealed significant tumor responses: 100% tumor control rate (TCR) was observed at all doses tested, and 24% partial response (PR) or complete response (CR) by RECIST criteria in the high dose cohorts. A dose-dependent relationship between overall survival and Rexin-G dosage was demonstrated, which was significant at the 5% statistical level by log rank test (p = 0.03). Median survival was 9.3 months and one-year survival was 33% in the high dose groups. Remarkably, one patient exhibited a complete response with the (adaptive) repeated cycles, attaining clinical remission after 9 months of continued treatment with Rexin-G. These findings indicate that intravenous Rexin-G is safe and well-tolerated with no cumulative toxicity and that Rexin-G controls tumor growth and may prolong over-all survival in a dose-dependent manner in patients with gemcitabine-resistant pancreas cancer.
About Epeius Biotechnologies:
Epeius Biotechnologies Corporation (www.epeiusbiotech.com) 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 .
Story References: Epeius Biotechnologies Corporation, Phase I and II Studies of Intravenous Rexin-G as Monotherapy for Gemcitabine-resistant Metastatic Pancreas Cancer, Dr Howard W Bruckner, tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, gene delivery systems.