We are excited to begin the pivotal Phase 3 trial in patients with malignant pleural mesothelioma in the second half of 2017...
Raleigh, NC (PRWEB) October 08, 2016
The makers of a new immunotherapy drug for malignant pleural mesothelioma say they will launch the final Phase 3 trial of the drug in late 2017. As Surviving Mesothelioma reports in a new article, the news comes on the heels of a Fast Track development designation by the FDA. Click here to read the details.
According to data from SELLAS, the company that makes the drug, a Phase 2 study conducted at Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center found that pleural mesothelioma patients on galinpepimut-S, a WT-1 immunotherapy vaccine, lived for a median of 8 months longer than the control group.
“We are excited to begin the pivotal Phase 3 trial in patients with malignant pleural mesothelioma in the second half of 2017 and expect the Fast Track designation to expedite the time to market, thereby enhancing the value proposition of galinpepimut-S in this indication,” said SELLAS CEO Angelos M. Stergiou, MD, in a statement.
Earlier this year, galinpepimut-S was granted Orphan Drug status by the FDA, a designation designed to encourage the development of drugs specifically for rare diseases like malignant mesothelioma.
“We are hopeful about the prospects for galinpepimut-S for the treatment of malignant mesothelioma, especially in light of the FDA’s Fast Track designation,” says Alex Strauss, Managing Editor for Surviving Mesothelioma. “We will continue to follow the progress of this mesothelioma vaccine closely as it moves into clinical trials next year.”
To learn about how the new WT-1 mesothelioma vaccine is believed to work, see Fast-Tracked Mesothelioma Drug Set for Phase 3 Trials, now available on the Surviving Mesothelioma website.
“SELLAS Life Sciences Receives FDA Fast Track Designation of Glainpepimut-S for the Treatment of Malignant Pleural Mesothelioma”, September 19, 2016, News Release, SELLAS website, http://sellaslifesciences.com/2016/09/sellas-life-sciences-receives-fda-fast-track-designation-of-galinpepimut-s-for-the-treatment-of-malignant-pleural-mesothelioma/