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Tumor-Targeted Rexin-G Prolongs Survival in Gemcitabine-Resistant Metastatic Pancreas Cancer in Advanced Phase I and II Studies (ASCO 2010)
Date:5/24/2010

SAN MARINO, Calif., May 24 /PRNewswire/ -- 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 overall 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 patien
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SOURCE Epeius Biotechnologies
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