Pharmaceutical Business review

Alfacell’s cancer drug fails endpoint

The preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The trial was designed to show a statistically significant improvement in overall survival (p < 0.048) for unresectable malignant mesothelioma (UMM) patients who were treated with a combination of Onconase plus doxorubicin as compared to patients who were treated with doxorubicin as a single agent. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving Onconase plus doxorubicin (unadjusted log rank p=0.80). The median survival time (MST) for evaluable patients who received Onconase plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent. However, statistically significant results were achieved in evaluable UMM patients (N=122) who failed a prior chemotherapy regimen before entering this clinical trial. Patients who received Onconase plus doxorubicin experienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin (unadjusted log rank p=0.016). Based on the preliminary statistical analysis of the data, Alfacell will continue with the planned submission of the remaining components of the Onconase rolling new drug application (NDA). Pending completion of the analysis of the data and further discussions with the FDA, the company currently estimates that the NDA submission will be completed by the end of calendar year 2008.