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news.Therion Biologics has completed enrollment in a phase III trial evaluating its drug candidate Panvac-VF in the treatment of metastatic pancreatic cancer.
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The company also announced that the drug has received orphan drug designation from the FDA for the treatment of pancreatic cancer. In the US, 32,000 patients annually are diagnosed with the disease, while over 31,000 patients annually die from the disease.
The randomized, controlled phase III clinical trial for Panvac-VF, being conducted under the guidance of a special protocol assessment (SPA) provided by the FDA, has enrolled 250 patients with pancreatic cancer who had received prior treatment with gemcitabine.
The SPA indicates that, if the trial successfully meets its primary endpoint of overall survival, the data will provide the basis for an efficacy claim in a marketing application for the product. Therion plans to submit a biological license application (BLA) to the FDA later this year.
“The pace of enrollment for our pivotal phase III study exceeded our expectations, which both underscores the overall promise of this candidate and moves us potentially through and beyond proof-of-concept towards a BLA filing this year. This study was designed to address the key, unmet medical need of patients with pancreatic cancer in the second-line setting for which there is currently no approved therapy,” said Thomas J Schuetz, chief medical officer.