According to Globe Newswire, the United States Food and Drug Administration (US FDA) designated a new orphan drug for the treatment of multiple myeloma on May 9th, 2018. The drug comes from the SELLAS Life Sciences Group, Inc. (SELLAS) and is known as galinpepimut-S or GPS. Keep reading to learn more, or follow the original story here for further details.
Multiple myeloma is a cancer that occurs within plasma cells. Plasma cells are a type of white blood cell which normally helps to battle off infection through the creation of antibodies. In cases of multiple myeloma, abnormal, cancerous plasma cells begin to build up in the bone marrow. This stifles the growth of healthy cells. In turn, the body then creates abnormal antibodies referred to as M proteins. Common symptoms of multiple myeloma include bone pain, kidney problems, fatigue, and low blood count. Click here to learn more about multiple myeloma.
SELLAS focuses largely on developing new immunotherapeutic treatments for cancer.
GPS, the group’s lead product, targets the Wilms Tumor 1 protein that is present in a variety of different tumors.
SELLAS already plans to test GPS in a Phase 3 clinical trial against two other forms of cancer (acute myeloid leukemia, and malignant plural mesothelioma). GPS is also being developed as treatment for ovarian cancer.
As a result of receiving orphan drug status, SELLAS will have a seven-year market exclusivity should their drug become approved. They also qualify for various tax credits surrounding clinical trials, and are able to waive FDA application fees. Orphan drug status is only granted to investigational drugs which treat or prevent a condition affecting fewer than 200,000 people in the US.
SELLAS’s President and Chief Executive Officer, Angelos Stergiou, MD, ScD h.c., says he is delighted for GPS to receive orphan drug status.
Dr. Stergiou also says that such a designation makes it obvious that there is a continued need for treatments to be developed for multiple myeloma and that GPS may be a serious contender.
Stergiou also does not hesitate to explain the success of GPS. Current reports indicate GPS achieved a median progression-free survival of 23.6 months. This compares favorably to previous standards, which reportedly peaked at only 12 months.