CRS-207 Receives Orphan Drug Status for Mesothelioma

CRS-207 has been granted orphan drug status by the U. S. Food and Drug Administration (FDA) for treatment of pleural mesothelioma patients. CRS-207, manufactured by Aduro Biotech, had previously been granted orphan drug designation for treatment of pancreatic cancer. The orphan drug designation is made by the FDA’s Office of Orphan Products Development to novel drugs that may help treat or prevent rare cancers and diseases affecting fewer than 200,000 people in the United States.

Orphan Drug Shows Promise in Clinical Trial for Stabilizing Disease in Patients With Pleural Mesothelioma

Patients eligible to receive treatment with CRS-207 include those who are not candidates for surgical resection of the tumor and who have not received any prior mesothelioma therapy. A single-arm, phase 1B clinical trial is now enrolling patients to receive CRS-207 in combination with the standard chemotherapy administered to pleural mesothelioma patients.

At the October 2014 International Mesothelioma Interest Group Conference, researchers presented interim results concerning CRS-207 treatment. The encouraging results demonstrated a 94% disease control rate in the 16 mesothelioma patients evaluated. Twelve patients experienced partial responses to the treatment and three patients showed a stabilization of their disease. One patient who had been participating in the study for over a year and a half was reportedly being treated solely with CRS-207 as opposed to the combination with standard chemotherapy.

In light of the encouraging results, drug maker Aduro is seeking to expand the study to include 40 patients by the end of 2015. Results of that broader study will be released in 2016.

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If you (or a loved one) have been diagnosed with mesothelioma, contact us by email or call us at 800.226.9880 to speak with our mesothelioma lawyers, like Gary Pauland Michael Gurien in our Los Angeles office, to learn more about how we can assist you and your family with a mesothelioma lawsuit.

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