Astellas Announces New Study Results Showing Increased Survival Rate for Metastatic Pancreatic Cancer

DEERFIELD, Ill., June 6, 2011 /PRNewswire/ -- Astellas Pharma Global Development, Inc., a subsidiary of Astellas Pharma Inc. based in Tokyo, Japan, today announced that it will be presenting data from a phase II study evaluating AGS-1C4D4 in metastatic pancreatic cancer in a poster session at the American Society of Clinical Oncology (ASCO) 2011 Annual Meeting in Chicago. The study was conducted at Agensys, Inc., a member of the Astellas global group of companies, which is developing a strong pipeline of therapeutic fully human monoclonal antibodies to treat solid tumor cancers.

AGS-1C4D4 is a fully human IgG1 antibody that targets the Prostate Stem Cell Antigen (PSCA) on the surface of tumor cells. PSCA is a GPI-linked plasma membrane protein expressed in multiple tumor types including pancreatic, prostate, bladder, and gastric cancers. In preclinical studies, AGS-1C4D4 has reduced tumor formation and metastasis, or spreading of the disease. It also slowed growth of established pancreatic tumors when combined with Gemcitabine.

This Phase II randomized trial demonstrates that the combination of AGS-1C4D4 plus gemcitabine is well tolerated and improves the six month estimated survival rate as compared to gemcitabine alone in patients with metastatic pancreas cancer. The trial also showed a favorable safety profile. With gemcitabine alone, the 6-month survival rate was 44.4 percent, while adding AGS-1C4D4 with gemcitabine increased this rate to 60.9 percent, which was statistically significant (p=0.0156 using the Cochran-Mantel-Haenszel statistical test). The trial was conducted in five countries and enrolled 196 patients with metastatic pancreatic cancer. The abstract (#4031) can be accessed at the ASCO website at www.asco.org.

"At Astellas we are committed to discovering and developing innovative therapies, such as AGS-1C4D4, that address the unmet medical needs of patients," said Leonard Reyno, senior vice president and chief medical officer of Agensys. "We're very encouraged by the results of this trial and we are considering conducting a placebo-controlled, randomized Phase 3 study to further research this unique compound."

Pancreatic cancer is the fifth leading cause of cancer death. According to the American Cancer Society, pancreatic cancer caused almost 37,000 deaths in 2010 and roughly 43,000 new cases are diagnosed each year.

About Astellas Pharma Global Development

Astellas Pharma Global Development, Inc., located in Deerfield, Illinois, is a member of the Astellas group of companies. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. The organization is committed to becoming a global category leader in focused areas by combining outstanding R&D and marketing capabilities. For more information about Astellas Pharma Inc., please visit the website at www.astellas.com/en/.

About Agensys

Agensys, Inc., an affiliate of Astellas Pharma Inc., is developing a pipeline of therapeutic fully human monoclonal antibodies (MAbs) to treat solid tumor cancers. The MAb product pipeline is generated by Agensys' diverse portfolio of proprietary, clinically relevant cancer targets that encompass 14 types of solid tumors. Agensys' target portfolio and related products are protected by a large patent estate. The company has full capabilities to generate, develop and manufacture antibody products. Agensys is progressing a pipeline of both naked and antibody-drug conjugated (ADC) therapeutic antibodies, directed at a variety of cancer indications, including those of the prostate, kidney, pancreas, ovary, bladder, lung, colon, breast and skin. ADC products are based on drug platform technologies developed by Seattle Genetics. Agensys is developing a growing pipeline of clinical stage functional MAbs and ADC products.

SOURCE Astellas Pharma Global Development, Inc.