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Study Published in Molecular Therapy Shows that Immune Response to FANG™ Personalized Cancer Therapeutic Correlates with Prolonged Survival in Patients with Advanced Stage Cancer
Date:3/1/2012

DALLAS, March 1, 2012 /PRNewswire/ -- Today Gradalis, Inc., announced that FANG™, the company's tumor-based personalized cancer therapeutic, elicits a robust and lasting immune response, resulting in statistically-significant prolonged survival in patients with advanced stage disease. The Phase 1 study, published today in the Nature Publishing Group journal Molecular Therapy, showed that treatment with FANG significantly increased survival in patients with advanced stage cancer compared to patients who received other forms of treatment in this non-randomized study.

The study evaluated 46 patients with varying tumor types, including melanoma, colorectal, breast, ovarian and hepatocellular cancers. A personalized FANG vaccine was manufactured from tumors removed from 42 of the 46 patients, and 27 patients received one monthly dose of the vaccine for up to 12 months. Twenty-three of the 27 patients receiving FANG achieved stable disease within two months of dose initiation. Median survival for the FANG group was 554 days compared to 132 days for the group that did not receive FANG. (P<0.0001) The "no FANG" group included 18 patients who had vaccine made but did not receive injections due to progression of disease or pursuit of other treatment options. FANG was well tolerated by all patients, and there were no treatment-related serious adverse events.

"The pronounced survival benefit achieved by FANG in patients with multiple tumor types is quite remarkable, and randomized Phase 2 trials are currently underway verifying these results," said John Nemunaitis, M.D., executive medical director of the Mary Crowley Cancer Research Centers and chief medical officer and co-founder of Gradalis. "The benefit is likely attributed to the triad approach which is designed into the vaccine to maximize its effect.  FANG is not only manufactured using each individuals' tumor to assure exposure to the appropriate antigens, but it also activates
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SOURCE Gradalis, Inc.
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