Raven to Present Updated Phase 1 Clinical Study Results of RAV12 Therapeutic Antibody for Treatment of Adenocarcinomas
SOUTH SAN FRANCISCO, Calif., Nov. 7 /PRNewswire/ -- Raven biotechnologies, inc., a privately held company focused on the development of monoclonal antibody therapeutics (MAbs) for cancer, today announced updated results from an ongoing Phase 1/2a clinical trial of RAV12, its lead therapeutic antibody in development for the treatment of adenocarcinomas. The data is being presented in an oral session on Wednesday, November 7 by Dr. Howard "Skip" Burris of the Sarah Cannon Cancer Center in Nashville, TN at the Chemotherapy Foundation Symposium in New York City.
Since entering Phase 1 clinical trials in December 2004, 42 patients have been treated. The dose escalation segment of the trial is complete and an expanded cohort of patients is now receiving the recommended dose and schedule of the drug in Phase 2a.
In his presentation, Dr. Burris will discuss the data underlying the choice of a dose and schedule of RAV12 to be taken into Phase 2 testing, as well as safety and efficacy data.
The trial is being conducted at five sites in the United States: The Sarah Cannon Cancer Center in Nashville, TN, with Howard Burris, M.D., as principal investigator; Premiere Oncology in Santa Monica, CA with Lee Rosen, M.D., as principal investigator; the Fox Chase Cancer Center in Philadelphia, PA with Nancy Lewis, M.D., as principal investigator; Georgetown University Medical Center in Washington, DC with John Marshall, M.D. as principal investigator; and the University of Miami Medical Center with Caio Max S. Rocha Lima, M.D., as principal investigator.
RAV12 is a novel, chimeric monoclonal antibody which 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, 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 GI Cancers
Adenocarcinomas are malignant tumors of the epithelial cells that line glands or viscera. They typically spread by way of the circulatory or lymphatic systems and are poorly treated after metastatic spread. More than 90 percent of colon, stomach and pancreatic tumor specimens express the RAV12 defined antigen, RAAG12. Adenocarcinomas arising elsewhere, such as breast, endometrial, ovarian, lung and prostate, display the antigen to varying degrees.
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, brain, and ovarian cancer.
CONTACT: Stephen Worsley, Vice President, Business Development, of Ravenbiotechnologies, inc., 1-650-624-2662, email@example.com
Web site: http://www.ravenbio.com/
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Posted: November 2007