ZUG, Switzerland and NEW YORK, Sept. 19, 2016 /PRNewswire/ -- SELLAS™ Life Sciences Group (SELLAS), a development-stage biopharmaceutical company
The FDA's Fast Track program is an expedited drug development and review program for new drugs or biologics which show promise in treating serious or life-threatening conditions and address an unmet medical need.
Galinpepimut-S, SELLAS' WT1 cancer vaccine, is a late clinical-stage immunotherapy being developed to target hematologic cancers and solid tumors, including MPM, AML, multiple myeloma, ovarian and other cancers. SELLAS plans to commence a pivotal Phase 3 trial in patients with MPM in the second half of 2017.
"This Fast Track designation underscores the importance of galinpepimut-S as a potential treatment option in mesothelioma. We are excited to begin the pivotal Phase 3 trial in patients with MPM 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 Dr. Angelos M. Stergiou, M.D., Vice Chairman and Chief Executive Officer of SELLAS.
"SELLAS has made rapid progress against its strategic goals in the past six months, and this milestone follows the FDA's Fast Track designation for AML, and recent orphan drug designations in the US and Europe for galinpepimut-S in both AML and MPM," he added. "Galinpepimut-S is demonstrating its potential as an anti-cancer agent, with outstanding results regarding survival, immunological responses, and safety in AML and MPM patients."
SELLAS's randomized, double-blind, placebo-controlled Phase 2 study in MPM patients enrolled a total of 40 patients at Memorial Sloan Kettering Cancer Center and M.D. Anderson Cancer Center.
According to Phase 2 MPM study data of galinpepimut-S presented at the 2016 International Mesothelioma Interest Group and the 2016 Annual Meeting of the American Society of Clinical Oncology:
MPM is a rare cancer caused primarily by the inhalation of microscopic asbestos fiber, and most cases can be traced to occupational exposure such as construction, automotive, military, marine and manufacturing industries. Mesothelioma is associated with a poor prognosis and costs of the entire course of treatment for malignant mesothelioma in the US are extremely high; estimates range from $150,000 to over $1,000,000.
The Company also has a clinical study underway for galinpepimut-S in multiple myeloma, and a combination clinical trial with Bristol-Myers Squibb's OPDIVO® (nivolumab) in ovarian cancer.
About SELLAS Life Sciences Group
SELLAS Life Sciences is a development-stage biopharmaceutical company focused on innovative products to treat cancer, particularly its lead product candidate, galinpepimut-S. Galinpepimut-S is a cancer immunotherapeutic agent licensed from Memorial Sloan Kettering Cancer Center that targets a broad spectrum of hematologic cancers and solid tumor indications. Galinpepimut-S is poised to enter pivotal Phase 3 clinical trials in patients with AML and Mesothelioma in the first and second half of 2017, respectively. SELLAS recently received orphan drug designations by the US FDA, as well as the EMA, for galinpepimut-S in AML and MPM; as well as Fast Track Designation for AML and MPM by the US FDA.
Galinpepimut-S also is in various development phases in multiple myeloma, ovarian cancer, and soon in other indications as monotherapy or in combination with other immuno-oncology agents.
SELLAS was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York.
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SOURCE SELLAS Life Sciences Group
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