According to a recent news feature from LABIOTECH, Sellas Life Sciences Group, based in Switzerland, has just received orphan drug status approval by the United States Food and Drug Administration (FDA) for its new drug known as WT1 vaccine.
WT1 vaccine is an immunotherapeutic cancer vaccine that is being developed to prevent two different types of cancer that generally affect the lungs and surrounding tissues. Those cancers are malignant pleural mesothelioma (caused by asbestos exposure in nearly all cases) and acute myeloid leukemia (AML). So far, there have been phase II trails with the drug on both conditions, and there have been what are known as positive top line results during this course of these phase II clinical trials.
After these results were released, the FDA felt it had enough information to approve the mesothelioma treatment option for orphan drug status. An orphan drug is one being developed to treat a very rare illness. The rare illness is typically called an orphan illness. The problem with orphan illnesses is that there is not a lot of money in it for drug makers, since there are not a lot of patients who will use the drug once it is designed.
Despite what we see on their commercials, drug companies typically care a lot more about making billions of dollars a year than they do about curing rare diseases, so when it comes to curing rare diseases, drug companies have little a bit more incentive in the form of the orphan drug program. When the FDA grants orphan drug status, the company gets the benefits of longer exclusivity periods (preventing generics from entering the market), an easier path to market, and other financial incentives.
While to the thousands of people who are diagnosed with and die from malignant pleural mesothelioma the rarity of the disease is of little concern, in comparison to other diseases, such as breast cancer, the numbers are actually quite small, which is why the disease has orphan status. As one might expect, and our Boston mesothelioma injury attorneys see every day, there are few if any truly effective treatment options on the market. The treatment options that do exist involve the administration of highly potent drugs, radiation, combined with highly invasive surgical procedures like the removal of one lung and part of the other. In the best of outcomes, a patient typically gets a year longer to live, but at the cost of extreme pain and suffering.
The drug company is hoping that they will be able to begin Phase 2b and even Phase 3 clinical trials for mesothelioma patients by the third quarter of 2016. Phase 2b is considered a transitional phase that takes a medicine from the “bench (laboratory) to the patient.” The way in which this drug, which is technically classified as a vaccine, works is that it uses a peptide chain to stimulate the patient’s immune system to fight what are known as WT1 antigens which are believed to largely responsible for the presence and growth of mesothelioma tumors.
If you or a loved one is diagnosed with mesothelioma in Boston, call for a free and confidential appointment at 1-888-367-2900.
Swiss Cancer Vaccine Gets 2 FDA Orphan Drug Designations, March 7, 2016, LABIOTECH.eu, By Denise NEves Gameiro
More Blog Entries:
Mesothelioma Lawsuits for Shipyard Workers, July 30, 2014, Boston Mesothelioma Lawyers Blog