According to a story from globenewswire.com, the biopharmaceutical company SELLAS Life Sciences Group, Inc. just announced that it has started screening participants for its phase 3 clinical trial. The trial will test the company’s investigational therapy candidate galinpepimut-S (GPS) as a treatment for patients with acute myeloid leukemia (AML). All patients recruited for the trial will have achieved complete remission; GPS is meant to act as cancer vaccine to prevent or delay relapse.
About Acute Myeloid Leukemia (AML)
Acute myeloid leukemia, also known as acute myelogenous leukemia, is a type of blood cancer which affects myeloblasts, stem cells that would normally develop into myeloid white blood cells. There are a number of risk factors for acute myeloid leukemia, including other blood disorders such as myelodysplastic syndrome, family history, certain genetic variants, chemical exposure (including chemotherapy agents), and radiation. Symptoms include an increased risk of infection, easy bruising and bleeding, fatigue, shortness of breath, fever, weight and appetite loss, anemia, and bone/joint pain. Treatment for this cancer is most often chemotherapy or stem cell transplant; there are very limited options for patients with relapsed disease. The five year survival rate for acute myeloid leukemia is only 27 percent in the US. There is a clear need for more effective treatments for this cancer. To learn more about acute myeloid leukemia, click here.
About The Clinical Trial
The clinical trial is expected to include 116 patients across 50 trial sites. The trial will compare GPS as a maintenance therapy alongside the study investigators’ “best choice” available maintenance therapy. Acute myeloid leukemia is a difficult to treat cancer that is known for its ability to relapse even after the achievement of complete remission. Patients with relapsed disease rarely respond effectively to continued treatment. In prior studies, GPS was able to improve survival by around 10.9 months. In the phase 2a study, GPS produced a median overall survival (OS) of 16.3 months compared to just 5.4 months in patients that did not receive it.
GPS has previously earned Orphan designations from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). In addition, the drug earned Fast Track designation from the FDA. Hopefully, this experimental treatment will continue to produce positive results in this upcoming study.
