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Raven Announces Initiation of a RAV12 Phase 2 Clinical Trial in Metastatic Pancreatic Cancer
Date:3/13/2008

SOUTH SAN FRANCISCO, Calif., March 13 /PRNewswire/ -- Raven biotechnologies, inc., a privately held company focused on the discovery and development of monoclonal antibody therapeutics (MAbs) for cancer, today announced that it has initiated a Phase 2 study of RAV12, its lead clinical product, in combination with gemcitabine in the treatment of patients with metastatic pancreatic cancer.

The Phase 2 Pancreatic Cancer Study will be conducted at approximately 20 institutions in the US. The first institution to open the trial is the Fox Chase Cancer Center in Philadelphia, PA. Eight sites will participate through the clinical trials consortium, the Pancreatic Cancer Research Team. More information regarding the study can be found at http://www.clinicaltrials.gov.

After an initial dose-escalation run-in segment of approximately 18 patients, the Phase 2 trial will enroll 63 patients in an efficacy segment. The target dose and schedule of RAV12, 0.75 mg/kg twice weekly, was chosen in a recently completed Phase 1/2a trial that involved 53 patients. Final analysis of the Phase 1/2a study will be available the third quarter of 2008.

About RAV12

RAV12 is a novel, chimeric monoclonal antibody that is directed against a primate-specific glycotope (sugar structure) that is widely displayed on the surfaces of tumor cells, particularly those of gastrointestinal origin (gastroesophageal, pancreatic, and colorectal cancers). Preclinical studies have demonstrated that RAV12 may kill tumor cells in a number of ways: first, the antibody is directly cytotoxic to a human colon cancer cell line in vitro through induction of oncotic cell death, a form of cell death characterized by cell and organelle swelling and loss of membrane integrity; second, the antibody mediates antibody-dependent cellular cytotoxicity; third, the antibody mediates complement dependent cell killing; and finally, the antibod
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