Mesothelioma Immunotherapy Vaccine Receives Orphan Drug Designation from FDA, Baron & Budd Reports

CRS-207 Drug Shows Substantial Promise in Shrinking Mesothelioma Tumors When Combined with Chemotherapy

DALLAS (April 23, 2015) – The mesothelioma law firm of Baron & Budd reports the U.S. Food and Drug Administration has granted orphan drug administration to CRS-207, an immunotherapy vaccine that could greatly impact treatment for malignant pleural mesothelioma. The designation was granted on March 26 to CRS-207 manufacturer Aduro Biotech, Inc.

In May 2014, a presentation to the International Mesothelioma Interest Group reported that CRS-207 showed a 94 percent success rate in helping control mesothelioma. The vaccine is derived from the bacterium (Listeria monycytogenes) that causes listeriosis, a serious infection. The drug stimulates a response against mesothelin, an antigen that is found in mesothelioma and other tumor cells. CRS-207 is administered before chemotherapy, which typically involves a combination of the drugs cisplatin and pemetrexed.

Side effects have so far been minimal, with vaccine recipients reporting a mild chilling sensation. In addition, it has been reported that patients who had previously lost 10-20 pounds during traditional treatment experienced increases in appetite and weight through the CRS-207/chemotherapy combination.

Several medical trials are underway involving the use of CRS-207. The trials, which are being held at medical facilities in Bethesda, MD, Chicago, Philadelphia, San Francisco and Tampa, FL, are expected to last until the end of 2015.

The orphan drug designation is designed to promote research and development of new disease treatments. It provides tax incentives for research, as well as grant funding and limited marketing exclusivity for seven years. CRS-207 has also received orphan drug designation for pancreatic cancer treatment.

“We are hopeful that CRS-207 might be an important advance regarding the treatment of malignant pleural mesothelioma,” said Russell Budd, president and managing shareholder of the mesothelioma law firm Baron & Budd.

About Baron & Budd, P.C.

The law firm of Baron & Budd, P.C., with offices in Dallas, Baton Rouge, Austin and Los Angeles, is a nationally recognized law firm with almost 40 years of experience "Protecting What’s Right" for people, communities and businesses. Baron & Budd’s size and resources enable the firm to take on large and complex cases. The firm represents individuals, businesses and public entities in litigation arising from diverse areas including dangerous pharmaceuticals and medical devices, environmental contamination, the Gulf oil spill, financial fraud, overtime violations, deceptive advertising, the WARN Act, automotive defects, trucking accidents, nursing home abuse, and asbestos-related illnesses such as mesothelioma.