Phase I/II Study of Targeted Gene Delivery In Vivo - Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients With Progressive Chemo-Resistant Bone and Soft Tissue Sarcoma (ASCO 2008)

SAN MARINO, Calif., May 29 Epeius Biotechnologies(http://www.epeiusbiotech.com) announced today the results of an on-goingPhase I/II study of Rexin-G for metastatic bone and soft tissue sarcoma (JClin Oncol 26: 14509, 2008). Rexin-G is the first and so far only targetedgene therapy vector that has been tested in the clinic (NatureReviews/Genetics 2007). In this open label study, cohorts of 6 to 7 patientswith all types of sarcoma, including osteosarcoma, Ewing's sarcoma,leiomyosarcoma, malignant fibrous histiocytoma, chondrosarcoma, fibrosarcoma,liposarcoma, angiosarcoma, spindle cell sarcoma, and malignant mixed Mulleriantumor of ovary, were treated with 1 x 10e11 cfu Rexin-G, administered i.v.over 5 minutes, 2 times a week for 4 weeks (Cumulative Dose = 8 x 10e11 cfu)followed by a 2-week rest period. Patients with Grade 1 or less toxicity weregiven progressive intra-patient dose-escalations consisting of additionaltreatment cycles of 1 to 2 x 10e11 cfu three times a week for 4 weeks(Cumulative Dose per cycle: 1.2-2.4 x 10e12 cfu).

These higher dosing regimens were associated with prolonged diseasestabilization and a median overall survival of greater than 6 months, whichwas three times longer than that observed in the low-dose group. Further,histologic examination of resected tumors showed 50-90% necrosis. Nodose-limiting toxicity was observed, even at the higher doses of Rexin-G, thusconfirming that repeated infusions of Rexin-G are safe and well-tolerated.Taken together with previous clinical studies conducted in the Philippines andJapan, these studies confirm the exemplary safety and dose-dependent efficacyof Rexin-G in a broad spectrum of chemotherapy-resistant cancers.

For more information about Rexin-G, on-going clinical trials in the USAand abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems,please contact Dr. Erlinda M. Gordon at [email protected].

*(LOGO 72dpi: Send2Press.com/mediaboom/08-0421-Epeius_72dpi.jpg)

This release was issued on behalf of the above organization bySend2Press(R), a unit of Neotrope(R). http://www.Send2Press.com

SOURCE Epeius Biotechnologies

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