Study Published in Molecular Therapy Shows that Immune Response to FANG™ Personalized Cancer Therapeutic Correlates with Prolonged Survival in Patients with Advanced Stage Cancer

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  immune cells and  prevents production of proteins that tumors use to avoid detection by the immune system. I believe that this triad approach may one day make it possible to turn cancer into a manageable chronic disease for many patients."

Eighteen patients who received FANG were evaluated using enzyme-linked immunospot (ELISPOT) assays to determine the extent of their cellular immune response to the FANG vaccine. Positive ELISPOT responses at four months were demonstrated in nine of the 18 patients evaluated, and this response was correlated to survival benefit (p=0.025). Positive immune response to FANG is durable, as seven of the nine ELISPOT responders were still alive when the manuscript was accepted for publication, having survival up to 500 days since start of treatment.  Routine, post-treatment monitoring of this patient group reveals that these seven patients are still alive today with survival ranging from 464 to 940 days. 

"In this study, FANG has prolonged life for a number of patients with advanced stage cancer who otherwise had little or no other treatment options," said David Shanahan, president, CEO and co-founder of Gradalis. "This study suggests that FANG may be applicable to multiple types of advanced cancer and may ultimately provide new treatment options, even for patients who have late stage or aggressive cancer."

FANG is currently being evaluated in several Phase 2 studies in patients with advanced ovarian cancer, advanced melanoma and advanced colorectal cancer with liver metastases.  In addition, Gradalis has initiated a clinical program evaluating FANG in children with Ewing's sarcoma.

About FANG

The FANG vaccine is manufactured from a cell suspension derived from a marble-sized portion of a patient's tumor removed during surgery. A plasmid expressing a well-established immune activator, granulocyte macrophage colony stimulating factor (GMCSF), and Gradalis' proprietary bifunctional short hairpin RNA construct against furin is introduced into the cells by electroporation. Cells are then incubated overnight, irradiated, frozen, QC-tested and released.  Vaccine is shipped to the patient's clinic where doses are thawed and administered monthly by intradermal injection.  FANG manufacturing is a straightforward two-day cGMP process that is applicable to nearly all tumor types with no modification, and it does not require patients to undergo apheresis or other taxing treatment protocols beyond medically-indicated surgical tumor removal.

About Gradalis, Inc.

Gradalis, Inc. is a privately-held, fully-integrated biotechnology company based in Dallas, Texas that is focused on developing, manufacturing and commercializing drugs, vaccines, tools and diagnostics primarily in the area of cancer. The company has two primary platforms:  one focused on personalized autologous vaccines and the other focused on bifunctional short hairpin RNA delivered via a proprietary lipoplex system. Gradalis has its own state of the art GMP manufacturing facility along with high-skilled technical leadership and staff, as well as a strategic partnership with Mary Crowley Cancer Research Centers for early stage clinical development of Gradalis products.  More information on the Company and its programs can be found at www.gradalisinc.com.

SOURCE Gradalis, Inc.

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