In 2014, doctors at the Memorial Sloan-Kettering Cancer Center began testing a Wilms Tumor-1 (WT1) vaccine to see if it delays or prevents malignant pleural mesothelioma from growing back after surgery. Now, the drug is in the hands of Sellas Life Sciences Group, and the company reports the Committee for Orphan Medicinal Products of the European Medicines Agency “has rendered a favorable opinion as regards to an Orphan Drug Designation.” This news follows the orphan drug designation granted by the U.S. Food and Drug Administration in February.
WT1 is over-expressed in many human cancers, including mesothelioma, and the National Cancer Institute recently ranked WT1 as the top target for cancer immunotherapy, according to Sellas.
The WT1 vaccine, also known as galinpepimut-S, is a late clinical-stage cancer immunotherapy expected to target certain cancers, including mesothelioma and leukemia. The vaccine has seen positive results in a Phase 2 trial in pleural mesothelioma patients demonstrating improved survival as well as doubled progression-free survival.
According to an April 5 press release from Sellas, based on the results, Sellas intends to initiate a Phase 2b/3 trial of the experimental drug in patients with pleural mesothelioma by the third quarter of 2016.
“The orphan designations for galinpepimut-S, both in the US and now the European Union, underscore the important unmet needs in treating patients with MPM [malignant pleural mesothelioma] and with AML,” said Angelos M. Stergiou, M.D., Chairman and Chief Executive Officer of SELLAS. “SELLAS is dedicated to advancing novel therapies that we believe can make a significant difference in the lives of desperately ill patients.”
Pleural mesothelioma is a terminal cancer of the lining of the lungs caused by past exposure to asbestos. Diagnosis of the cancer is challenging and is most often not diagnosed until the late stages of the disease. The cancer is diagnosed in nearly 3,000 Americans each year.
Clinical Trials Benefit Mesothelioma Patients
Many times, the best chances for improved survival for mesothelioma patients is through a clinical trial. According to the National Institutes of Health, clinical trials are at the heart of all medical advances. Mesothelioma patients that participate in clinical trials not only help the medical community in general, but they can realize many benefits for their specific medical needs.
Mavis Nye of England spent countless hours looking for a clinical trial to halt the growth of her pleural mesothelioma. She is living proof that trial participants can realize unprecedented results. Read her story at “Clinical Trial Frees Mavis Nye of Mesothelioma.”
Don Smitley and David Stetler, of MesotheliomaHelp’s “Faces of Mesothelioma,” both participated in mesothelioma clinical trials. The two had exhausted their treatment options, and they were able to receive breakthrough treatments, get temporary relief from mesothelioma symptoms, and ultimately, help other mesothelioma patients.
In fact, Don Smitley, whose struggles with the disease are captured in a blog by his daughter, Jennifer Gelsick, was a participant in the WT-1 clinical trial conducted at Memorial Sloan-Kettering Cancer Center in New York City.
Jennifer reported at the time that it was a blessing for her father to be chosen to be part of the WT-1 trial at MSKCC. She says that when deciding to take part in a clinical trial that although it may seem daunting at first, the benefits can far outweigh the hardships.
“We are proud of the progress of our WT1 vaccine program, and we expect to initiate pivotal studies of the WT1 vaccine in both MPM and AML later this year, as well as additional mid-stage studies in diverse indications,” said Angelos M. Stergiou, M.D.
MSKCC is the world’s oldest and largest private cancer center, and has a team of specialists including surgical oncologists, medical oncologists, radiation oncologists, pathologists, and nurses who deal exclusively with mesothelioma and other thoracic cancers. They are committed to providing the best possible treatments for patients with malignant pleural mesothelioma, and often conduct clinical trials and studies for mesothelioma as they continue to make strides in the treatment of the deadly disease.
For more information about the WT-1 clinical trial see ClinicalTrials.gov.