A new immunotherapy vaccine, CRS-207, was recently approved by the U.S. Food and Drug Administration (FDA) to be used as an orphan drug for mesothelioma treatment. Several mesothelioma physicians are excited about the new vaccine, and feel this could be a new and more successful way help malignant mesothelioma patients.
What is An Orphan Drug?
An orphan drug, according to the FDA, are medications and biologics which are approved for the safe use of rare diseases, such as mesothelioma. Rare diseases are defined as illnesses that affect 200,000 or less people in the United States. Currently, there are are more than 400 orphan drugs approved to treat various rare diseases.
What is CRS-207?
Per the National Cancer Institutes (NCI), CRS-207 is an attenuated and genetically modified form of Listeria monocytogenes. Once Listeria is weakened and modified, it produces an immune response that fights off cancerous tumors. CRS-207 has been shown in clinical trials to spark a strong response in antigen mesothelin, which has high levels on mesothelioma tumors.
Dirk Brockstedt, Ph.D, senior vice president of research and development at Aduro Biotech, Inc, the immuno-oncology company that developed CRS-207, states the orphan drug may be a breakthrough in helping mesothelioma patients live longer.
“This is an important step for Aduro as we continue to develop CRS-207 for this very difficult to treat cancer. We believe the combination of CRS-207 together with chemotherapy may offer the promise of a potential new therapeutic regimen for patients suffering from mesothelioma. Importantly, we plan to report additional data from the ongoing Phase 1b study later this year.”
How Can Mesothelioma Patients Get CRS-207 as Treatment?
Currently, since CRS-207 is an orphan drugs, it’s being utilized at numerous clinical trials across the nation. NCI states that the clinical trials include CRS-207 in combination with chemotherapy (Alimtin and Cisplatin) as a frontline way to treat malignant mesothelioma.
Each clinical trial has a set of qualifications and criteria that must be met in order to join. Generally age and health are factored in, and most qualified patients are those who ineligible for surgery and have not started any other form of treatment for mesothelioma. However, it’s important to contact the clinical you’re interested for a full list of qualifications.
NIH’s Clinical Trial services indicate that clinical trials for CRS-207 will continue throughout the year, until December 2015, at the following locations:
- University of California at San Francisco, Contact: Scott Hammond, 415-885-3673, firstname.lastname@example.org
- H. Lee Moffitt Cancer Center, Contact: Germaine M González-Vazquez, BS, CCRP, 813-745-8350, email@example.com
- University of Chicago Medical Center, Contact: Peter Ostiguy, BA, 773-834-1472, firstname.lastname@example.org
- National Cancer Institute, Contact: Yvonne Mallory, RN, BSN, 301-402-0255, email@example.com
- University of Pennsylvania Abramson Cancer Center, Contact: Mona Jacobs-Small, B.S., RRT, CCRC, 215- 662-8632
According to Dr. Raffitt Hassan, principal investigator of the study at NCI, patients are generally given two CRS-207 vaccinations, spaced out two weeks apart, followed by several chemotherapy sessions and additional vaccinations. Dr. Hasaan is confident in CRS-207 and feels it might be extremely successful in treating mesothelioma patients, yet it’s still in its orphan phase, and will require additional investigation.
“While the findings warrant further investigation, I believe the addition of CRS-207 to the standard chemotherapy regimen used in this trial may enhance overall response rates and may boost the duration of those responses.”
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