Source: SELLAS Life Sciences Group & reported by http://www.prnewswire.com/
ZUG, Switzerland and NEW YORK, Feb. 29, 2016 /PRNewswire/ -- SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company focused on innovative products to treat cancers and central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for the Company's WT1 cancer vaccine for the treatment of patients with Malignant Pleural Mesothelioma (MPM). SELLAS recently reported positive results of a Phase 2 trial of its WT1 vaccine in MPM patients, showing that overall survival improved and progression-free survival doubled. Based on these findings, SELLAS intends to initiate a pivotal Phase 2b/3 trial of its product candidate in patients with MPM by the third quarter of 2016.
"We are thrilled with the progress of our WT1 vaccine program, which has received two orphan designations in the last two months and is advancing into pivotal studies in AML and in MPM patients in 2016, as well as further Phase 2 studies including in multiple myeloma, ovarian cancer, glioblastoma multiforme, and a series of genetically defined cancers in a basket-trial design," said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS.
Miltiadis Sougioultzoglou, M.D., SELLAS's Executive Vice President, commented, "MPM is a difficult-to-treat and aggressive cancer, and fewer than five percent of patients survive beyond five years. There is a significant need for new treatment options, and we look forward to the commencement of the pivotal Phase 2b/3 trial."
Read more: http://www.prnewswire.com/news-releases/sellas-life-sciences-announces-fda-orphan-drug-designation-for-wt1-cancer-vaccine-in-patients-with-malignant-pleural-mesothelioma-300227450.html