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July 16, 2014
08:32 EDTOMEDOncoMed initiates Phase 2 ALPINE trial of tarextumab
OncoMed Pharmaceuticals announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE", or Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety, clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab, being studied for the treatment of pancreatic cancer. Tarextumab is being tested in combination with Abraxane plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival, or PFS, of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.
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July 28, 2015
08:51 EDTOMEDOncoMed initiates Phase 1 clinical trial for Anti-RSPO3 antibody
OncoMed Pharmaceuticals announced dosing of the first patient in its anti-RSPO3 antibody Phase 1a/1b clinical trial. Anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. The Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors. Patients will receive escalating doses of anti-RSPO3 until disease progression. The open-label study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to obtain additional preliminary information on possible anti-tumor activity. In the Phase 1b portion of the trial, anti-RSPO3 will also be tested in second-line colorectal cancer patients in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI. The trial is being conducted at five sites in the United States.

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