Raven Announces Phase 1 Clinical Trial Results of RAV12 Therapeutic Antibody for Treatment of Adeno...( - Study Results Determin...),Health

- Study Results Determine Phase 2 Dosing Regimen -

SOUTH SAN FRANCISCO, Calif., Nov. 19 /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 open-label, dose escalation clinical trial of RAV12, its lead therapeutic antibody in development for the treatment of adenocarcinomas. The objectives of the study were to define the safety profile and maximum tolerated dose of RAV12, to define the pharmacokinetics and describe preliminary efficacy.

"The study results demonstrate that a fractionated dosing regimen allows us to deliver RAV12 with an acceptable level of toxicity, while maintaining exposure that is associated with a tumor response," said George Schreiner, M.D., Ph.D., chief executive officer of Raven biotechnologies. "We are particularly encouraged to have seen a clinical response in one of the patients with advanced stage gastrointestinal cancer. These findings further demonstrate the potential therapeutic value of RAV12."

Study Design

The phase 1 dose-escalation safety and pharmacokinetics (PK) trial was initiated in December 2004 in patients with recurrent adenocarcinoma who had received 1 to 3 prior treatment courses. RAV12 was administered initially four times weekly, then by fractionated dosing two or three times weekly. Thirty-three patients were treated in the dose escalation segment of the trial. Three cohorts were given a weekly dose of 0.3 mg/kg, 1.0 mg/kg, and 1.5 mg/kg, and three cohorts received fractionated dose schedules of 0.5 mg/kg twice weekly, 0.75 mg/kg twice weekly, and 0.5 mg/kg thrice weekly.

Patients all had confirmed adenocarcinoma of gastrointestinal origin or of other origin if they positively expressed the RAAG12 antigen. The majority of patients had colorectal, gastroesophageal, or pancreatic cancer. Patient responses were evaluated
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