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June 4, 2014
08:49 EDTOMEDOncoMed to present data for Notch1 program
OncoMed Pharmaceuticals will present new data at the upcoming 19th European Hematology Association Congress related to the company's anti-Notch1 clinical-stage program. At the EHA Congress, OncoMed will present the first data for its proprietary Next Generation DNA Sequencing assay developed with MolecularMD to identify Notch1 mutation status in patients with certain hematologic malignancies. OncoMed is currently conducting two separate Phase 1 clinical studies of its Notch1 targeting antibody in patients with certain advanced solid and hematologic tumors, respectively.
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February 8, 2016
08:10 EDTOMEDOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
08:09 EDTOMEDOncoMed discontinues dosing in ALPINE trial, unblinds study
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