BioCentury
ARTICLE | Clinical News

Ipafricept: Phase Ib ongoing

September 8, 2014 7:00 AM UTC

OncoMed said FDA lifted a partial hold on the company's Phase Ib trials evaluating ipafricept. The trials are evaluating the product in combination with carboplatin and paclitaxel to treat recurrent platinum-sensitive ovarian cancer; in combination with Abraxane nab-paclitaxel and gemcitabine to treat previously untreated pancreatic cancer; and in combination with Nexavar sorafenib as first-line treatment of locally advanced or metastatic hepatocellular carcinoma (HCC). In June, FDA placed the hold on ipafricept, as well as a partial hold on the company's vantictumab ( OMP-18R5), after OncoMed halted separate trials evaluating the 2 products due to mild to moderate bone-related adverse events (see BioCentury, June 16). According to OncoMed, FDA lifted the partial hold on ipafricept following a review of safety and efficacy data and revised study protocols submitted by the company with modified dosing regimens, risk mitigation measures and modified enrollment criteria.

FDA lifted the partial hold on vantictumab last month (see BioCentury, Sept. 1). Vantictumab, a human HuCAL mAb targeting the Wnt pathway, is in Phase Ib trials in combination with Abraxane and gemcitabine to treat previously untreated stage IV pancreatic cancer; in combination with paclitaxel to treat locally advanced or metastatic HER2-negative breast cancer; and in combination with docetaxel as second- and third-line treatment of advanced non-small cell lung cancer (NSCLC). ...