SOUTH SAN FRANCISCO, Calif., March 13 Ravenbiotechnologies, inc., a privately held company focused on the discovery anddevelopment of monoclonal antibody therapeutics (MAbs) for cancer, todayannounced that it has initiated a Phase 2 study of RAV12, its lead clinicalproduct, in combination with gemcitabine in the treatment of patients withmetastatic pancreatic cancer.
The Phase 2 Pancreatic Cancer Study will be conducted at approximately 20institutions in the US. The first institution to open the trial is the FoxChase Cancer Center in Philadelphia, PA. Eight sites will participate throughthe clinical trials consortium, the Pancreatic Cancer Research Team. Moreinformation regarding the study can be found at http://www.clinicaltrials.gov.
After an initial dose-escalation run-in segment of approximately 18patients, 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 ina recently completed Phase 1/2a trial that involved 53 patients. Finalanalysis 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 aprimate-specific glycotope (sugar structure) that is widely displayed on thesurfaces of tumor cells, particularly those of gastrointestinal origin(gastroesophageal, pancreatic, and colorectal cancers). Preclinical studieshave 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 vitrothrough induction of oncotic cell death, a form of cell death characterized bycell and organelle swelling and loss of membrane integrity; second, theantibody mediates antibody-dependent cellular cytotoxicity; third, theantibody mediates complement dependent cell killing; and finally, the antibodyalters cellular signaling required for cell survival. RAV12 is highlyefficacious in human colon, gastric, and pancreatic tumor xenograft models invivo and has been found to be well tolerated in repeat dose primate toxicologystudies.
About Pancreatic Cancer
Adenocarcinoma of the pancreas is a major unmet medical need andrepresents the fourth leading cause of cancer death in the US. Approximately34,000 new cases of pancreatic cancer are reported in the US each year.Five-year survival rates are approximately 1% to 2%. Gemcitabine was approvedfor use in pancreatic cancer a decade ago, but little advance in treatmentoutcomes has occurred since.
Raven biotechnologies, inc. (http://www.ravenbio.com) is a privately heldbiotechnology company focused on the development of monoclonal antibodytherapeutics for treating cancer. Raven's lead product candidate, RAV12,targets adenocarcinomas and is in clinical development for the treatment ofgastrointestinal and other cancers. Raven's discovery process simultaneouslyidentifies cell-surface drug targets and the antibody therapeutics to regulatethem. Our focus on biological function allows us to rapidly identify noveltarget antigens and therapeutic candidates in their native configuration inthe intact cell membrane. Our integrated approach is based on proprietarymethods for optimizing the production of MAbs targeting cell-surface proteins,including the use of human tissue-specific progenitor and tumor stem celllines developed at Raven.
To date Raven has identified multiple candidate therapeutic MAbs for manycancer indications including lung, colon, pancreatic, prostate, breast andovarian cancer.
On November 12, 2007, Raven and VaxGen Inc. (OTC: VXGN.PK), abiopharmaceutical company, announced that their respective boards of directorsunanimously approved a definitive merger agreement. The merger is expected tocreate a drug development company with a robust pipeline of monoclonalantibody candidates in