Raven Announces Phase 1 Clinical Trial Results of RAV12 Therapeutic Antibody for Treatment of Adeno...(on day 42. Study Results RAV12 was...),Health

Study Results

RAV12 was moderately well-tolerated with fractionated dosing that allowed delivery of an "effective dose" (i.e. 1.5 mg/kg total dose over one week time) as 0.75 mg/kg twice weekly. The two primary side effects observed were Infusion-associated abdominal discomfort and diarrhea, and elevated liver function tests. Both side effects appear related to CMax as they tended to appear early on after dosing and tended to resolve rapidly after dosing, and were ameliorated by fractionated dosing.

Treatment with RAV12 demonstrated preliminary evidence of anti-tumor activity. One patient with refractory colorectal cancer experienced a partial remission with time to progression exceeding 8 months and one patient with advanced pancreatic cancer had a > 50% reduction in the relevant tumor marker, CA19-9 and experienced disease stability for more than five months.

As a result of these findings, future development of RAV12 both as single agent and in combination with chemotherapy is planned for 2008. The recommended dose and schedule for Phase 2 clinical study of RAV12 is 0.75 mg/kg twice weekly.

About RAV12

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 efficacio
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