Astellas to present positive AGS-1C4D4 phase II data in metastatic pancreatic cancer at ASCO 2011

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>

"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.