A treatment that was recently “fast tracked” by the FDA for the treatment of acute myeloid leukemia (AML) has now received the same status for the treatment of malignant pleural mesothelioma patients.
According to a press release by SELLAS™ Life Sciences, a development-stage biopharmaceutical company, the Galinpepimut-S cancer vaccine – the treatment in question – is a late clinical-stage immunotherapy that is being developed to treat solid tumors and hematologic cancers.
Thanks to the recent Fast Track status, which allows for an expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need, SELLAS hopes to commence with a Phase 3 trial for this drug, involving patients with malignant pleural mesothelioma treatment (MPM), by 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 completed a double-blind, randomized, placebo-controlled Phase 2 trial with this drug for pleural mesothelioma patients at M.D. Anderson Cancer Center in Texas and Memorial Sloan-Kettering Cancer Center in New York. It involved 40 patients and, the company reports, the overall results were quite promising.
Specifically, the overall median survival rate increased by about 8 months for those treated with Galinpepimut-S compared to those individuals in the control arm of the study. Furthermore, the drug was very well tolerated by those who took part in the clinical trial.
Also, individuals whose mesothelioma was resectable and who had already undergone surgery benefited from subsequent treatment with the drug. Overall, the study was viewed as a great success and hopes are that the Phase 3 trial will be as successful.
This report underscores the importance of clinical trials and locating an oncologist who is in tune with the latest studies offered to patients with pleural mesothelioma and other types of the disease. While it may mean that some patients need to travel in order to locate such a doctor and, hence, to receive the best care available, it is often worth both the money and time spent.
Clinical trials are never a sure thing, but many have extended the lives of patients with all sorts of cancers and other diseases, and when a doctor recommends one, it is certainly worth serious consideration.