OncoMed: FDA Removes Clinical Hold On Enrollment In Vantictumab Phase 1 Trials

(RTTNews) - OncoMed Pharmaceuticals Inc. (OMED) announced the U.S. FDA has removed the partial clinical hold on enrollment in the company's vantictumab (anti-Fzd7, OMP-18R5) Phase 1 clinical trials. The partial clinical hold occurred on July 1, 2014 following the company's voluntary halt to its Wnt pathway programs due to observed on-target mild-to-moderate bone-related adverse events.

The company said FDA removed the partial clinical hold to permit the enrollment of vantictumab clinical trials following its review of a substantial clinical safety and efficacy data package and revised study protocols submitted by the company. The amendments for the Phase 1b combination trials include modified dosing regimens, risk mitigation measures, such as increased monitoring and bone protection strategies, and modified enrollment criteria.

Vantictumab is being studied in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in patients with advanced non-small cell lung cancer (NSCLC), advanced HER2-negative breast cancer and advanced pancreatic cancer. Enrollment and dosing of new patients is expected to resume within the next few weeks.