News & Views
OncoMed Pharmaceuticals begins Phase 1 clinical trial of OMP-52M51
Mar 08 2013
OncoMed Pharmaceuticals has announced that patient dosing has begun in its Phase 1 clinical trial of OMP-52M51 in patients with advanced refractory solid tumours.
The Phase 1 clinical trial of OMP-52M51 in solid tumours is an open-label dose escalation and expansion study, focusing on patients with advanced refractory solid tumours.
Individuals will be assessed for safety pharmacokinetics pharmacodynamics, along with initial evidence of efficacy.
The work will also assess a predictive biomarker-based patient selection approach and will take place at a number of sites in the US.
Dr. Amita Patnaik of START, who treated the first patient with OMP-52M1 on the solid tumour trial, said: "It is exciting to begin a clinical trial with this therapeutic with a novel anti-cancer stem cell mechanism of action to patients with advanced solid tumors. The companion predictive diagnostic test also makes this a cutting-edge program."
Paul Hastings president and chief executive officer of OncoMed Pharmaceuticals, said: "We continue to make progress on our broad first-in-class clinical pipeline of anti-cancer stem cell therapeutics.
"OncoMed’s novel Anti-Notch1 antibody is the fifth product candidate in the clinic and several of OncoMed’s other candidates are advancing towards Phase 2 testing. We look forward to generating important clinical data with Anti-Notch1 and our other novel agents that target cancer stems cells.”
OMP-52M51 is an antibody that is targeted to the Notch1 receptor ad has shown substantial anti-tumour and anti-CSC activity in Notch-dependent hematologic malignancies and solid tumours.
Particular hermatologic malignancies have mutations that increase Notch1 signalling activity and may be a primary driver of tumour growth, while also acting as resistance to chemotherapy.
Predictive biomarker tests have been identified to enable analyses of potential predictive biomarkers in clinical trials for OMP-52M51 to discover the subsets of patients with specific hematologic malignancies or certain solid tumours that could benefit the most from the drug.
Posted by Ben Evans
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