June 12, 2014: TGen, Scottsdale Healthcare and Virginia G. Piper Leads Unprecedented Clinical Trial.
Medical investigators at the Virginia G. Piper Cancer Center at Scottsdale Healthcare are studying a new cancer immunotherapy to see if it can successfully help patients with advanced pancreatic cancer.

The Phase 2B clinical trial of CRS-207 and GVAX Pancreas vaccines is open at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a partnership with the Translational Genomics Research Institute (TGen), where cancer patients are treated with promising new drugs.

Participants in the study, named ECLIPSE (Efficacy of Combination Listeria/GVAX Immunotherapy in the Pancreatic Cancer Setting), will be randomized so patients receive only the CRS-207 vaccine, or that vaccine combined with the GVAX Pancreas vaccine and low doses of cyclophosphamide. A third group of patients will receive a standard chemotherapy.

“This is a very innovative approach using immunotherapy to treat pancreatic cancer,” explained Dr. Erkut Borazanci, M.D., M.S., medical oncologist and Drug Development Scholar at Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare and the study’s lead investigator.

The CRS-207 vaccine is a weakened form of the bacteria, Listeria monocytogenes, that has been genetically modified to be safe for human use, while retaining its ability to stimulate the immune system. Specifically, CRS-207 has been engineered to stimulate an immune response against the tumor-associated antigen mesothelin, which is present at high levels on pancreatic cancer cells.

The GVAX vaccine is composed of genetically modified, inactivated pancreatic cancer cells that have been shown to stimulate the immune system’s anticancer activity. The vaccine is given with a low-dose of a common cancer drug called cyclophosphamide to boost the effectiveness of the vaccine.

In a recently completed Phase 2A trial in 93 patients with advanced pancreatic cancer, survival was improved in patients who received the combination regimen of CRS-207, GVAX and cyclophosphamide (6.1 months), compared to 3.9 months for those who received only cyclophosphamide and GVAX. The immunotherapies were well-tolerated, with no serious treatment-related adverse side effects.

Virginia G. Piper Cancer Center Clinical Trials is among the first 11 centers in the United States participating in the study. The drug was developed by Aduro BioTech, Inc., a clinical-stage immunotherapy company located in Berkeley, Calif. A total of 240 patients are expected to be treated at more than 20 clinical trial sites in North America.

“If this study is successful, we hope that this form of immunotherapy will become widely available across the country to treat patients with advanced pancreatic cancer,” added Dr. Borazanci.

Pancreatic cancer is difficult to treat and is the fourth leading cause of cancer-related death in the U.S. Tumors may grow in the pancreas without any early symptoms, which means that the disease is often in an advanced stage when it is diagnosed, and survival remains poor.

Virginia G. Piper Cancer Center Clinical Trials is known worldwide for its expertise in studying new treatments for pancreatic cancer.

Individuals seeking information about eligibility to participate in clinical trials at the Virginia G. Piper Cancer Center at Scottsdale Healthcare may contact the cancer care coordinator at 480-323-1339; toll free at 1-877-273-3713 or via email at clinicaltrials@shc.org. Additional information is available at www.clinicaltrials.gov (NCT02004262).

About the Virginia G. Piper Cancer Center at Scottsdale Healthcare

The Virginia G. Piper Cancer Center at Scottsdale Healthcare, an affiliate of the non-profit Scottsdale Lincoln Health Network, is designated by the Association of Community Cancer Centers as a Community Resource Center for Pancreatic Cancer and holds Accreditation with Commendation from the Commission on Cancer of the American College of Surgeons. Located in Scottsdale, Ariz., it offers comprehensive cancer care and research through Phase I clinical trials, diagnosis, treatment, prevention and support services in collaboration with leading researchers and community oncologists. For more information on cancer services at Scottsdale Healthcare, visit shc.org.

About TGen

Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with cancer, neurological disorders and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scientists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. For more information, visit: www.tgen.org.