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news.Raven biotechnologies has reported that it is continuing enrolment in the maximum tolerated dose cohort expansion segment of its Phase I/IIa trial for patients with cancers of the gastrointestinal tract that express the RAAG12 antigen.
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RAV12 is a novel, chimeric monoclonal antibody that is directed against a primate-specific glycotope (sugar structure) widely displayed on the surfaces of tumor cells, particularly those of gastrointestinal origin. RAV12 is said to be 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.
The appropriate dose and schedule of RAV12 was chosen in a dose-escalation segment of the Phase I/IIa trial that involved 33 patients. This trial revealed that a fractionated dosing regimen provided an improved safety profile for the antibody.
Raven is now enrolling patients in a second segment of the trial in which all patients are receiving the recommended dose and schedule of drug. Information from the Phase I/IIa trial will be supporting the dosing in a Phase II study in pancreatic cancer, the next clinical trial scheduled for RAV12.