FDA Puts Halozyme Pancreatic Cancer Trial On Clinical Hold
Halozyme Therapeutics announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its patient enrollment and dosing of PEGPH20 in an ongoing Phase 2 trial (Study 202) assessing PEGPH20 in patients with pancreatic cancer.
The company said that the clinical hold has been placed in view of its own decision to temporarily halt enrollment and dosing of PEGPH20 in the trial. Halozyme cited the recommendation from an Independent Monitoring Committee (DMC) for its decision, stating, “The DMC is assessing clinical data that indicates a possible difference in the thromboembolic event rate between the group of patients treated with PEGPH20, nab-paclitaxel and gemcitabine versus the group of patients treated with nab-paclitaxel and gemcitabine without PEGPH20. The Company is halting enrollment and dosing of PEGPH20 as precautionary actions while the DMC's full evaluation of the data is ongoing.”
PEGPH20 is an investigational form of Halozyme’s Hylenex recombinant human hyaluronidase, which is FDA-approved. Hylenex facilitates the absorption and dispersion of other injected fluids or drugs for subcutaneous fluid administration. PEGPH20 increases the half-life of the compound in the blood and enables intravenous administration.
Dr. Helen Torley, president and CEO of Halozyme, said, “As announced earlier, we are gathering information relevant to assessing the possible difference in the thromboembolic event rate between the patients treated with PEGPH20 versus the patients treated without PEGPH20 in the trial. We will be providing this information to the Data Monitoring Committee and the FDA in parallel so they can complete their respective assessments.”
The American Cancer Society forecasted that over 46,000 people will be diagnosed with pancreatic cancer in 2014. Of these, nearly 40,000 will die because of the disease.
“Pancreatic cancer has one of the lowest survival rates of any cancer. We remain committed to evaluating PEGPH20 as a possible therapy to address this devastating disease,” CEO Torley said.