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.
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 antibody alters cellular signaling required for cell survival. RAV12 is highly efficacious in human colon, gastric, and pancreatic tumor xenograft models in vivo and has been found to be well tolerated in repeat dose primate toxicology studies.
About Pancreatic Cancer
Adenocarcinoma of the pancreas is a major unmet medical need and represents the fourth leading cause of cancer death in the US. Approximately 34,000 new cases of pancreatic cancer are reported in the US each year. Five-year survival rates are approximately 1% to 2%. Gemcitabine was approved for use in pancreatic cancer a decade ago, but little advance in treatment outcomes has occurred since.
Raven biotechnologies, inc. (http://www.ravenbio.com) is a privately held biotechnology company focused on the development of monoclonal antibody therapeutics for treating cancer. Raven's lead product candidate, RAV12, targets adenocarcinomas and is in clinical development for the treatment of gastrointestinal and other cancers. Raven's discovery process simultaneously identifies cell-surface drug targets and the antibody therapeutics to regulate them. Our focus on biological function allows us to rapidly identify novel target antigens and therapeutic candidates in their native configuration in the intact cell membrane. Our integrated approach is based on proprietary methods for optimizing the production of MAbs targeting cell-surface proteins, including the use of human tissue-specific progenitor and tumor stem cell lines developed at Raven.
To date Raven has identified multiple candidate therapeutic MAbs for many cancer indications including lung, colon, pancreatic, prostate, breast and ovarian cancer.
On November 12, 2007, Raven and VaxGen Inc. (OTC: VXGN.PK), a biopharmaceutical company, announced that their respective boards of directors unanimously approved a definitive merger agreement. The merger is expected to create a drug development company with a robust pipeline of monoclonal antibody candidates in oncology, proprietary antibody discovery platforms, biopharmaceutical manufacturing capabilities and sufficient cash to fund operations at least through the end of 2009. The merger is expected to close in the first half of 2008.
|SOURCE Raven biotechnologies, inc.|
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