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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

Published: Mon, 21 Apr 2008, 08:30:26 EDT

Edited by Carly Zander

Second Phase Opens with Higher Dose Regimens

SAN MARINO, Calif., April 21 (SEND2PRESS NEWSWIRE) -- 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.

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 egordon @epeiusbiotech.com.

Rexin-G(R) 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 throughout the body. The FDA has granted Orphan Drug Status for Rexin-G for the treatment of pancreatic cancer while the Philippine BFAD has granted accelerated approval of Rexin-G for the treatment of all solid tumors that are resistant to standard chemotherapy.

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 proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for partnership or clinical trials, please visit: www.epeiusbiotech.com.

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ADDITIONAL NEWS FROM Epeius Biotechnologies Corporation

» Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G » Targeted Gene Delivery Signals Cancer Vaccination in Vivo » TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008) » ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity without Toxicity in Metastatic Pancreatic Cancer » Interim Analysis of Phase I/II Study of Rexin-G Confirms Efficacy with No Dose Limiting Toxicity in Metastatic Pancreatic Cancer

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