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Press Release Source: Raven biotechnologies, inc.

Raven Presents Preliminary Clinical Results From Phase 1 Study of RAV12 Therapeutic Antibody for Treatment of Adenocarcinomas

Tuesday August 15, 9:00 am ET

--Presentation at 6th International Congress on Monoclonal Antibodies in Cancer on August 19--

SOUTH SAN FRANCISCO, Calif., Aug. 15 /PRNewswire/ -- Raven biotechnologies, inc. (www.ravenbio.com), a privately held company focused on the development of monoclonal antibody therapeutics (MAbs) for cancer, today announced preliminary results from an ongoing Phase 1 clinical trial of RAV12, its lead therapeutic antibody in development for the treatment of adenocarcinomas. The data will be presented in an oral session by Stanford J. Stewart, M.D., vice president of clinical research at Raven, at the 6th International Congress on Monoclonal Antibodies in Cancer in Washington, D.C. on August 19, 2006.


So far, the multicenter Phase 1 trial has evaluated three treatment cohorts of 21 patients who received RAV12 in escalating weekly intravenous doses of 0.3 mg/kg to 1.5 mg/kg over four weeks. Results to date from 15 evaluable patients have shown that RAV12 was associated with a partial remission in one patient and stable disease in three patients. In two patients with refractory adenocarcinomas, time to progression exceeded four months.

These preliminary clinical data are encouraging. In particular, the observation of clinical responses with RAV12 shows the therapeutic potential of our antibody technology," commented Jennie P. Mather, Ph.D., president and chief scientific officer of Raven.

Preliminary results showed that the maximally tolerated dose was reached when the antibody was administered as a single weekly injection. Side effects associated with that dose included infusion-associated abdominal discomfort and liver function test abnormalities. At lower doses, abdominal discomfort and liver function test abnormalities were transient.

The trial is being conducted at three sites in the U.S., including The Sarah Cannon Cancer Center in Nashville, Tenn., with Howard Burris, M.D., as principal investigator; Premiere Oncology in Santa Monica, Calif. with Lee Rosen, M.D., as principal investigator; and the Fox Chase Cancer Center in Pittsburgh with Nancy Lewis, M.D., as principal investigator.

About RAV12

RAV12 is a high affinity IgG1 chimeric monoclonal antibody that recognizes a primate restricted, N-linked carbohydrate epitope expressed on a number of human carcinomas, including an especially high percentage (>90 percent) of adenocarcinomas of gastrointestinal origin. Preclinical studies have demonstrated that RAV12 is directly cytotoxic to human colon cancer cell lines in vitro. The mechanism of action of RAV12 appears to involve the induction of oncotic cell death, a form of cell death characterized by cell and organelle swelling and loss of membrane integrity. 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.

About Raven

Raven biotechnologies, inc. (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. In addition, we have identified multiple candidate therapeutic MAbs for many indications, including lung, colon, pancreatic, prostate, breast, brain and ovarian cancer. 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.


Source: Raven biotechnologies, inc.

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