Alfacell announced that a Phase IIIb clinical trial involving Onconase failed to show a statistically significant improvement in median survival time for patients diagnosed with unresectable malignant mesothelioma.
The study compared patients receiving Onconase (ranpirnase) and doxorubicin to those who only received doxorubicin. Out of 320 patients, the median survivial time for those receiving Onconase plus doxorubicin was 11.1 months whereas patients receiving doxorubicin as a single agent survived 10.7 months.
While the results were disappointing, patients who had previously failed a chemotherapy regimen showed a statistically significant improvement in overall survival when given Onconase and doxorubicin. The median survival time was 10.5 months compared to 8.7 months for patients only receiving doxorubicin.
Alfacell plans to file a New Drug Application with the FDA seeking approval for Onconase to treat this specific group of patients and the company estimates the application will be completed by the end of this year.
The company is also conducting a Phase I/II trial of Onconase in non-small cell lung cancer (NSCLC) and other solid tumors. For more information on this trial please visit Alfacell.com.