Boston, MA 09/08/2014 (wallstreetpr) – Oncomed Pharmaceuticals Inc (NASDAQ:OMED) announced that it had got relief from the holds of FDA on its ipafricept (FZD8-Fc, OMP-54F28) Phase 1 clinical trials. The clinical trials were facing partial clinical holds from the U.S. Food and Drug Administration. Oncomed can start with its enrollment process and dosing of new patients. The study site IRBs have received and approved the revised trial protocols.
The partial hold
Previously, in the month of June, Oncomed Pharmaceuticals Inc (NASDAQ:OMED) took the voluntary decision to stop the enrollment in its Phase 1 clinical trials of vantictumab and ipafricept programs. It was taken as a precautionary measure as the trials resulted in the mild-to-moderate bone adverse incidents. FDA supported OncoMed’s decision and placed the trial on clinical hold. Only the enrolled patients who showed benefit without any side effects were allowed for the continued dosing.
The modified parameters
Oncomed worked hard to get the key inputs from the clinical investigators and other academic experts. After a thorough assessment, Oncomed Pharmaceuticals Inc (NASDAQ:OMED) developed a new set of modified study parameters so as to avoid potential risks linked with the study. The new parameters also allow Oncomed to evaluate the therapeutic impact of its ipafricept on the patients suffering from hepatocellular, ovarian and pancreatic cancers in combination with standard therapy.
The submission
Oncomed Pharmaceuticals Inc (NASDAQ:OMED) prepared an efficacy data and clinical safety package for ipafricept. It also formulated the revised study protocols and submitted to FDA, the approval of which led to the removal of the partial clinical hold. The list of amendments includes risk mitigation measures like bone protection strategies along with increased monitoring, modified dosing regimens and modified enrollment criteria. Jakob Dupont, Chief Medical Officer of OncoMed, said that the company is delighted to get a prompt response on the submitted proposed amendments linked with the trial protocols. The acceptance is a new start in the clinical trial of ipafricept.
