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REXIN-G Shrinks Metastatic Tumors and Triples Survival Time in Chemotherapy-Resistant Pancreatic Cancer: Analysis of a U.S. Phase I/II Clinical Trial (Proceedings of ASCO GI Symposium 2009)
Date:1/20/2009

SAN MARINO, Calif., Jan. 20 /PRNewswire/ -- Epeius Biotechnologies (www.epeiusbiotech.com) announced the results of a U.S. Phase I/II study evaluating the safety and efficacy of Rexin-G in chemotherapy-resistant metastatic pancreatic cancer (ASCO GI Symposium, #249; Sant P Chawla, P.I., Santa Monica CA, January 2009). Rexin-G was well tolerated and there was no dose-limiting toxicity. At Dose Level I, three patients achieved stable disease with no tumor progression; and at Dose Level II, one patient had a 37% decrease in tumor size and five patients exhibited disease stabilization with no tumor progression. Importantly, Rexin-G improved patient survival in a dose-dependent manner: At Dose Level I, median progression-free survival was 3 months, and median over-all survival was 5 months, while at Dose Level II, median progression-free survival was greater than 3 months, and median over-all survival was greater than 9 months.

By direct comparison with a prior low-dose Phase I safety study (Galanis et al. 2008), the new "effective doses" of Rexin-G nearly tripled the overall survival time. Thus, this current Phase I/II study defines a critical pharmacological "threshold" for Rexin-G bioactivity in the treatment of metastatic pancreatic cancer. The present study confirms the overall safety of Rexin-G, and further demonstrates that Rexin-G monotherapy, at these defined dose levels, exhibits profound anti-tumor activity that prolongs both progression-free survival and over-all survival time in pancreatic cancer patients that had previously failed standard chemotherapy.

Rexin-G is the world's first and so far only targeted injectable genetic medicine that has been validated in the clinic (Nature Reviews/Genetics 2007). Injected intravenously, the targeted nanoparticles are designed to seek out and destroy both primary tumors and metastatic cancers that have spread t
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