Raven Announces Completion of Enrollment in the Phase 1/2a Clinical Trial of RAV12 Therapeutic Antibody for the Treatment of Adeno... ( SOUTH SAN FRANCISCO Calif. Feb. 1...)

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Raven Announces Completion of Enrollment in the Phase 1/2a Clinical Trial of RAV12 Therapeutic Antibody for the Treatment of Adenocarcinomas

Date:2/13/2008

SOUTH SAN FRANCISCO, Calif., Feb. 13 /PRNewswire/ -- Raven biotechnologies, inc., a privately held company focused on the development of monoclonal antibody therapeutics (MAbs) for cancer, today announced that it completed enrollment of patients in the maximum tolerated dose (MTD) cohort expansion segment of its Phase 1/2a trial of RAV12, an anti-cancer monoclonal antibody. The trial enrolled patients with cancers that express the RAAG12 antigen, particularly those of gastrointestinal origin. All patients in the trial have undergone radiographic re-evaluation to assess their response to treatment. Based on this assessment, two patients remain on study drug beyond the original treatment period. A total of four patients received extended therapy in both the original cohort and the expanded cohort of this trial.

"We continue to be pleased with our advances with RAV12 and the indications of its potential therapeutic value." said George Schreiner, M.D., Ph.D., chief executive officer of Raven biotechnologies.

RAAG12 is a glycotope (sugar structure) that is widely found on the surface of tumor cells of many kinds of cancer, particularly cancers of the gastrointestinal tract (adenocarcinomas of gastroesophageal, pancreatic and colorectal origin). RAV12, Raven's lead clinical monoclonal antibody drug candidate, targets the RAAG12 antigen.

An analysis of data from this trial is expected in the second or third quarter of this year. The analysis will produce an evaluation of safety, definitive pharmacokinetics, evaluation of immunogenicity, and estimates of efficacy in a refractory patient population.

The appropriate dose and schedule of RAV12 previously was chosen in a dose-escalation segment of the Phase 1/2a trial that involved 33 patients. This trial revealed that a fractionated dosing regimen provided an improved side effect profile for the antibody. The recently concluded MTD Cohort Expansion segment involved 20 additional patients. '/>"/>

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