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Source: PhameLive, October 24, 2006

Further Analysis of Phase III Data Using CALGB and EORTC Paradigms Reinforces Survival Benefits of ONCONASE(R) for the Treatment of Patients With Mesothelioma

Alfacell Corporation today announced results from further detailed analysis of the company's previously reported Phase IIIa clinical trial of ONCONASE® (ranpirnase) versus doxorubicin for the treatment of unresectable malignant mesothelioma (UMM). The post-hoc analysis found that patients treated with ONCONASE had greater median survival times than patients treated with doxorubicin alone using the validated prognostic scoring systems of both the Cancer and Leukemia Group B (CALGB) and European Organization for Research and Treatment of Cancer (EORTC). These scoring systems were not the original endpoints of the Phase IIIa trial. The new findings were presented on Sunday, October 22 at the 8th International Conference of the International Mesothelioma Interest Group (IMIG), held in Chicago, IL at the Sheraton Chicago Hotel and Towers, by Joachim von Pawel, M.D, Chief of Oncology, Askleplos Specialized Clinic, Center for Pneumology and Thoracic Surgery, Gauting, Germany. Dr. von Pawel's presentation was entitled, "A Comparison of CALGB and EORTC Paradigms in the Assessment of ONCONASE(r) for the Treatment of Unresectable Malignant Mesothelioma (UMM)."

For malignant mesothelioma, the prognostic scoring systems developed by CALGB and EORTC are the most widely accepted of those currently available for this malignancy. These systems use performance status, age, histological subtype, weight loss, and hematological parameters to stratify patients into prognostic groups. Each is useful for interpreting the benefit of chemotherapy in clinical trials.

The first objective of this new analysis was to determine whether the application of the CALGB and EORTC prognostic models to the combined treatment groups would separate the patients into prognostic subgroups which correlated with survival outcome. When all patients were categorized by these two prognostic models, the survival results were consistent with the published data for these models.

The second objective was to evaluate survival outcomes for patients treated with ONCONASE versus doxorubicin. When the data were analyzed using each paradigm, the treatment differences favored ONCONASE. The EORTC survival analysis showed a six-month difference between "high" and "low" risk groups for patients treated with ONCONASE (15 months compared to 9 months [p = 0.0063]). A two-month difference was seen among patients treated with doxorubicin (10 months for "high" risk patients compared to 8 months for "low" risk patients [p = 0.375].

In assessing CALGB group variables, patients who were of epithelial histology had markedly greater median survival times when treated with ONCONASE (16.5 months compared to 13.6 months, doxorubicin). The same was true among patients considered to have suboptimal prognoses under either paradigm, such as Performance Status 1 patients (11.5 months compared to 9 months).

"The EORTC system is robust for the stratification of small trials, while the CALGB prognostic scoring system, with six strata for risk, demands a large sample size to ensure statistically significant subgroup separation," said Dr. von Pawel. "These findings add to our growing body of knowledge about the potential utility and promise of ONCONASE in the treatment of UMM, and will be valuable in its ongoing development."

Within the last decade, malignant mesothelioma has received increased international attention by distinguished medical and radiation oncologists, surgeons, pulmonologists, epidemiologists and basic scientists who research this disease or treat patients due to the increasing incidence worldwide. In 2005, the first major federal PO1 grant for this disease was awarded to Michele Carbone, M.D., Ph.D., Chairman of Alfacell's Thoracic Cancer Ad