FANG™ Personalized Tumor Vaccine Stimulates Immune Response and More than Doubles Time to Recurrence in Patients with Advanced Stage Ovarian Cancer

DALLAS, May 15, 2013 /PRNewswire/ -- Today Gradalis, Inc. announced that FANG™, the company's tumor-based personalized cancer vaccine, elicits an immune response and delays time to recurrence in advanced stage ovarian cancer patients by more than one year compared to patients who received standard of care. Interim analysis of the Phase II randomized study will be presented at the Annual Meeting of the American Society of Gene and Cell Therapy in Salt Lake City, Utah, in an oral presentation titled "Randomized Phase II Trial of Adjuvant Autologous Tumor Cell Vaccine (FANG) for High Risk III/IV Ovarian Cancer:  Preliminary results" by Neil Senzer, M.D., of the Mary Crowley Cancer Research Centers.

The randomized study has currently enrolled 17 patients with stage IIIc or stage IV ovarian cancer, the most advanced stages of the disease in which the cancer has spread to other organs. Twelve patients received the FANG personalized vaccine plus standard treatment, and five patients received only the standard treatment which consists of tumor removal and chemotherapy. The primary endpoint of the study is time to recurrence. At the interim analysis, a positive tumor immune response as measured by enzyme-linked immunospot (ELISPOT) analysis was observed in 71 percent of the FANG treatment group. The mean time to recurrence from start of treatment for patients receiving FANG was 470 days and growing, more than 140 percent longer than the group receiving standard of care, which had a mean time to recurrence of 193 days.  FANG was very well tolerated, with no adverse events reported.

"In this study of women who otherwise have a very poor prognosis, we are seeing a significant delay of recurrence in the FANG treatment group which is increasing daily," said Minal Barve, M.D., Texas Oncology, lead investigator on the study. "This interim analysis of the Phase II study suggests that FANG is very promising as a potential treatment for ovarian cancer and lays the groundwork for a pivotal Phase III study of FANG in this patient population desperately in need of better treatment options."

A follow-up analysis of the patients from the Phase I study of FANG will also be presented at the conference by John Nemunaitis, M.D., executive medical director of the Mary Crowley Cancer Research Centers and chief medical officer and co-founder of Gradalis, in a poster titled "Long Term Follow Up – Phase I Study of the 'triad' autologous (FANG) vaccine, incorporating bifunctional shRNA^furin and GMCSF Transgene Expression in Advanced Cancer Patients."

Long-term follow up of the 32 patients in the Phase I study with various types of late-stage cancer who received FANG showed a median survival of 562 days compared to 86 day median survival for the 23 patients who met study inclusion criteria but elected to undergo other treatment options (P<0.000001). Based on an analysis of risk factors derived from a database of 1,181 patient assessments from the MD Anderson Clinical Center, the expected survival for patients enrolled in the FANG clinical study was between 6.2 and 8.4 months. Treatment with FANG therefore more than doubled overall survival time to 18.7 months for patients with very advanced cancer who had an otherwise poor prognosis. FANG was well tolerated by all patients, and there were no treatment-related serious adverse events.

"Taken together, the results of the Phase I and Phase II studies are quite exciting, as we have demonstrated that FANG elicits a robust and lasting immune response that delays cancer recurrence and prolongs life," said Dr. Nemunaitis. "By harnessing the power of the patient's own immune system, the triad approach which is designed into the FANG vaccine may one day make cancer a manageable chronic condition by activating immune cells and preventing production of proteins that tumors use to avoid detection by the immune system."

Today Dr. Nemunaitis presented an overview of all of the FANG clinical data as an invited speaker at the conference in a podium presentation titled "Clinical Update of bi-shRNA furin/GMCSF DNA Transfected Autologous Tumor Vaccine (FANG) in Cancer Patients."

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. Gradalis has its own state of the art GMP manufacturing facility along with high-skilled technical leadership and staff.  More information on the Company and its programs can be found at www.gradalisinc.com.

SOURCE Gradalis, Inc.