Intravenous Infusions of REXIN-G - Demonstrates Dose-Dependent Anti-Tumor Activity Without Toxicity in Patients
SAN MARINO, Calif., May 29, 2008 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (www.epeiusbiotech.com) announced today the results of an on-going Phase I/II study of Rexin-G for metastatic bone and soft tissue sarcoma (J Clin Oncol 26: 14509, 2008). Rexin-G is the first and so far only targeted gene therapy vector that has been tested in the clinic (Nature Reviews/Genetics 2007).
In this open label study, cohorts of 6 to 7 patients with all types of sarcoma, including osteosarcoma, Ewing's sarcoma, leiomyosarcoma, malignant fibrous histiocytoma, chondrosarcoma, fibrosarcoma, liposarcoma, angiosarcoma, spindle cell sarcoma, and malignant mixed Mullerian tumor 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 were given progressive intra-patient dose-escalations consisting of additional treatment 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 disease stabilization and a median overall survival of greater than 6 months, which was three times longer than that observed in the low-dose group. Further, histologic examination of resected tumors showed 50-90% necrosis. No dose-limiting toxicity was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.
Taken together with previous clinical studies conducted in the Philippines and Japan, these studies confirm the exemplary safety and dose-dependent efficacy of Rexin-G in a broad spectrum of chemotherapy-resistant cancers.
For more information about Rexin-G, on-going clinical trials in the USA and abroad, and/or Epeius pathotropic (disease-seeking) gene delivery systems, please contact Dr. Erlinda M. Gordon at email@example.com.
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NEWS SOURCE: Epeius Biotechnologies Corporation
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MEDIA ONLY CONTACT(S):
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Erlinda M. Gordon, M.D. Epeius Biotechnologies Corporation +1-626-441-6695 egordon @ epeiusbiotech.com
Posted: May 2008