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Press Release:
ASCO 2008: Tumor-Targeted Rexin-G Demonstrates Dose-Dependent Anti-Tumor Activity without Toxicity in Metastatic Pancreatic Cancer
SAN MARINO, Calif., May 19 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies announced today the results of an on-going Phase I/II study of Rexin-G for metastatic pancreatic cancer (Chawla et al., ASCO meeting, 2008). Continuing on with the planned dose-escalations of Rexin-G which began in 2005 using lower doses of Rexin-G in a Phase I safety study (Molecular Therapy, 2008), the current Phase I/II study employed higher dose-escalations of Rexin-G given i.v. two to three times a week for 4 weeks, beginning with 8 x 10e11 cfu to 6 x 10e12 cfu with a goal to safely reach the point where the clinical anti-tumor activity of Rexin-G would be clearly and unequivocally demonstrated.
The results of this latest Phase I/II study of targeted gene delivery in vivo are very encouraging-intravenous infusions of Rexin-G demonstrated significant biological activity without toxicity in patients with progressive chemo-resistant pancreatic cancer. Once the overall safety record of repeated infusions of Rexin-G was clearly demonstrated, the FDA approved across the board intra-patient dose-escalations (an adaptive design) to gain better tumor control.
These higher doses of Rexin-G were associated with stabilization of disease, using both RECIST and International PET criteria, significant reductions in CA 19.9 levels, and an increase in median overall survival (greater than 6 months) which was twice that observed in the low-dose safety study. No dose-limiting toxicity was observed, even at these higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated.
The importance of these progressive dose-escalation studies - which clearly establish safety before escalating to more potent tumoricidal levels - is of primary concern in the development of a new genetic medicine like Rexin-G. Moreover, the establishment of a functional dose-response relationship is also of fundamental significance, not only in terms of basic pharmacology, but in establishing the physiological mechanisms-of-action that are of major importance in determining the predictability of a new anti-cancer agent, in establishing the optimal dose regimens for a given type of cancer, and ultimately in gaining regulatory approval for Rexin-G in the United States.
Taken together with the results of previous studies, the current on-going Phase I/II study confirms the exemplary safety and therapeutic potential of Rexin-G, the first and so far only targeted gene delivery system shown to be safe and effective in the clinic.
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 egordon @epeiusbiotech.com.
On the Web: www.epeiusbiotech.com.
NEWS SOURCE: Epeius Biotechnologies Corporation
Send2Press® is the originating wire service for this story. Terms of Use. © Epeius Biotechnologies Corporation. All trademarks acknowledged.
THE CONTENT OF THE ABOVE PRESS RELEASE WAS PROVIDED BY THE NEWS SOURCE (Epeius Biotechnologies Corporation), WHO IS SOLELY RESPONSIBLE FOR ITS ACCURACY. FOR QUESTIONS ABOUT THIS STORY CONTACT THE NEWS SOURCE AND NOT THIS WEBSITE.
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