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Results of the Phase II Multicenter Trial of ONCONASE(R) As a Single Agent

SOURCE: Alfacell Corporation

Encouraging Survival in Patients With Advanced Malignant Mesothelioma Treated With Alfacell's ONCONASE ®

BLOOMFIELD, N.J., Jan. 22 /PRNewswire-FirstCall/ -- Alfacell Corporation (OTC Bulletin Board: ACEL - news), today announced the publication of Phase II trial results of ONCONASE ®, a novel anti-cancer drug, in patients with unresectable, or inoperable, malignant mesothelioma (MM), an asbestos-related cancer of the inner lining of the chest and abdomen, in the January 1, 2002 issue of the Journal of Clinical Oncology (Vol. 20, pp. 274-281).

The 1-year and 2-year survival rates overall were 34.3% and 21.6%, for the 105 patients treated with ONCONASE in this study. Thirty-seven percent of those enrolled did not respond to prior systemic chemotherapy.

Median survival rates typically range from six to eight months for unresectable (inoperable) MM patients treated with systemic therapy. The dismal therapeutic outcome for this disease has led many physicians to recommend only supportive care to their patients. Any drug that shows even minimal activity is of interest to physicians, patients and their families.

ONCONASE (ranpirnase) is a proprietary ribonuclease anti-cancer drug developed from the eggs of Rana pipiens, the leopard frog. Ribonuclease enzymes interrupt protein synthesis, resulting in the inhibition of cell growth and the induction of apoptosis (programmed cell death).

Study results were analyzed using criteria developed by the Cancer and Leukemia Group B (CALGB), a national cooperative oncology group working out of Duke University. Through a 10-year retrospective study of 337 patients, the CALGB identified 6 groups based on prognosis for survival.

The intent-to-treat (ITT) group includes all 105 patients enrolled in the study recently reported in the Journal of Clinical Oncology, and the treatment target group (TTG) (81 of the total 105 patients enrolled) includes those patients who met the predefined CALGB criteria for categories 1 to 4 combined.

These results corroborated the clinical importance of the specifically defined prognostic categories as reported earlier by the CALGB. Those in the TTG had one and two-year survival rates of 42% and 26.8%, respectively, compared to 34.3% and 21.6% for the ITT group.

In addition, those forty-one (41) patients whose tumors either shrank or whose cancer was halted from progressing had a median survival of 18.5 months, 1-year of 61% and 2-year survival rates of 40.8%, respectively.

A randomized, controlled Phase III trial of the combination of ONCONASE® with doxorubicin (an anti-cancer drug) vs. doxorubicin in the TTG population of patients with unresectable, or inoperable, malignant mesothelioma is ongoing in the U.S. and Europe.

In February 2001, ONCONASE was granted Orphan Medicinal Product Designation in Europe for the treatment of patients with malignant mesothelioma. Epidemiologists have predicted that over 250,000 people will die from malignant mesothelioma in Europe alone in the next 35 years.

Earlier studies using ONCONASE demonstrated that some patients experienced clinically meaningful survival benefit (similar to this Phase II trial). ONCONASE treatment has been well tolerated in the majority of patients and has not been associated with the hair loss, bone marrow suppression (failure of the bone marrow to make new blood cells, including red blood cells, resulting in anemia), nausea, and mucous membrane toxicity typically associated with chemotherapy. In the more than 700 patients treated with ONCONASE in various clinical trials, to date, none have experienced drug-related death.