• Amgen Inc., of Thousand Oaks, Calif., said results of a biomarker analysis indicated that the efficacy of Vectibix (panitumumab) monotherapy is confined to patients with nonmutated (wild-type) KRAS tumors. Analysis of that study, which enrolled metastatic colorectal cancer patients who have failed other chemotherapeutic regimens, showed that in those with nonmutated KRAS tumors, Vectibix treatment significantly increased progression-free survival (PFS) and had an impact on quality of life and disease-related symptoms vs. best supportive care (BSC) alone. Median PFS in patients without the mutation who received Vectibix plus BSC was 12.3 weeks vs. 7.3 weeks in patients with the mutation. Vectibix was approved in 2006 as a monotherapy in patients with EGFR-expressing mCRC after disease progression. Data from the KRAS and other biomarker analyses will be integrated into Amgen's ongoing clinical program of the drug in earlier lines of mCRC therapy in combination with chemotherapy, as well as in other tumor types.

• Gentium SpA, of Villa Guardia, Italy, said the data safety monitoring board initiated the planned interim analysis of the company's Phase III study of Defibrotide in severe veno-occlusive disease and concluded that there are no safety concerns at this time. The board has asked the firm to clarify and supplement certain trial data in order to complete the remainder of the analysis. To date, the trial has enrolled 76 patients in the prospective treatment arm.

• Protherics plc, of London, said it enrolled the first patient in a Phase IIb study of OncoGel, a locally administered sustained-release formulation of paclitaxel, in esophageal cancer. The product is designed to improve locoregional control of solid tumors. The trial will evaluate OncoGel, administered in combination with preoperative chemoradiotherapy vs. preoperative chemoradiotherapy alone in 124 patients. The primary endpoint is a blinded assessment of tumor response, while the secondary endpoints include overall survival. Protherics expects preliminary data in the first half of 2010.