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Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy With No Dose Limiting Toxicity in Metastatic Pancreatic Cancer
Date:4/21/2008

Second Phase Opens With Higher Dose Regimens

SAN MARINO, Calif., April 21 /PRNewswire/ -- Epeius Biotechnologies Corporation announced today that Interim Analysis of an on-going Phase I/II study of Rexin-G for pancreatic cancer confirmed Rexin-G's anti-tumor activity with no major toxicity in patients with metastatic chemotherapy-resistant pancreatic cancer. The clinical trial design includes 5 escalating doses of intravenous Rexin-G ranging from 1 x 10e11 cfu twice a week to 4 x 10e11 cfu three times a week for 4 weeks. Treatment cycles are repeated if the patient exhibits Grade 1 or less toxicity. Interim analysis showed no dose limiting toxicities in 9 evaluable patients who received Dose Levels 1-3. Furthermore, the analysis showed decrease in tumor size or disease stabilization (by RECIST), decreased metabolic activity in tumors (by PET-CT scan), reduction in tumor marker levels, and clinical benefit in patients receiving Dose Level 3. The second phase of the Rexin-G study has now opened wherein six patients will receive Dose levels 4 and 5, respectively, as the Phase I/II adaptive study design continues to evaluate the over-all safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the clinical benefits required to support a Phase II/III pivotal trial.

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According to Dr. Sant P. Chawla, Principal Investigator of the Phase I/II study, "I am happy with the positive results of Rexin-G seen in pancreatic cancer, and look forward to obtaining even better results with progressively higher doses of Rexin-G." Dr. Chawla is currently conducting three Los Angeles-based Phase I/II clinical trials using Rexin-G in sarcoma, pancreatic cancer, and breast cancer, and a Phase II study of Rexin-G for osteosarcoma. For further information concerning these clinical trials, please contact Dr. Erlinda M. Gordon at

SOURCE Epeius Biotechnologies Corporation
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