Anti-Tumor Activity Shown By Rexin-G

May 21, 2008 · 49 views · Filed Under Cancer Treatment

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Epeius Biotechnologies announced the results of an on-going Phase I/II study of Rexin-G for metastatic pancreatic cancer. 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.

Full Story: Anti-Tumor Activity Shown By Rexin-G
Source: Epeius Biotechnologies

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