September 5, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
California-based OncoMed Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has removed the partial hold on its ipafricept Phase 1 clinical trials. As a result, OncoMed will continue enrollment, and patients will begin participating in experiments within the next few weeks.
“With important input from our clinical investigators and academic bone experts, the OncoMed team has developed modified study parameters intended to avoid potential risks while allowing us to evaluate the therapeutic impact of ipafricept for patients with pancreatic, hepatocellular and ovarian cancers in combination with standard therapy,” said Jakob Dupont, M.D., OncoMed’s Chief Medical Officer. “We appreciate the FDA’s prompt response to our submission and their acceptance of our proposed amendments to the trial protocols.”
OncoMed gave the FDA a clinical safety and efficacy package for the drug. In turn, the FDA placed the partial clinical trial on hold. Modified dosing regimens, risk mitigation measures and modified enrollment criteria were the amendments of the Phase 1b trials.
On June 13, OncoMed announced that it would voluntarily be halting enrollment in its Phase 1 vantictumab and ipafricept Wnt pathway programs. This came after reported incidents of mild-to-moderate bone adverse events. After the FDA looked at more data and amended study protocols given to it by OncoMed, it decided to remove the partial hold on the clinical trials.
“We expect enrollment in our first-in-class Wnt pathway programs, ipafricept and vantictumab, to be back underway soon,” said Paul J. Hastings, Chairman and Chief Executive Officer of OncoMed. “The Wnt pathway represents a highly promising target for disrupting cancer stem cell activity and inducing tumor differentiation. As we advance ipafricept and vantictumab through clinical studies in combination with standard of care, we expect to generate key data from these Phase 1b studies that will support a potential opt-in by our partner Bayer as well as late-stage clinical development.”
Ipafricept is a fusion protein that inhibits a signaling pathway in cancer called the Wnt pathway. It binds to ligands that are activators in Wnt signaling. Patients who received ipafricept in a Phase 1a study tolerated the treatment well, and experimentations showed that the fusion protein demonstrated on-target Wnt pathway modulation.
OncoMed Pharmaceuticals is dedicated to discovering and developing therapeutics that target cancer stem cells. The company has five anti-cancer products in clinical development.
