SOURCE: Alfacell Corporation
BLOOMFIELD, N.J., April 3 /PRNewswire-FirstCall/ — Alfacell Corporation today announced that the encouraging survival data from its Phase II multicenter trial of ONCONASE®, led the Company to conduct a Phase III program which included the evaluation of ONCONASE as a single agent at 33 centers across the United States and the combination ONCONASE + doxorubicin in more than 30 centers in the US and Europe. ONCONASE is a novel anti-cancer drug for the treatment of patients with unresectable (inoperable) malignant mesothelioma (MM), an asbestos-related cancer of the inner lining of the chest and abdomen.
Currently a pivotal, international, randomized trial is ongoing in the U.S. and Europe comparing ONCONASE + doxorubicin to doxorubicin alone. This trial is being conducted in patients with both peritoneal and pleural mesothelioma and allows patients to enter the trial even if they have failed one prior chemotherapy regimen, radiation or both. “This prospectively designed confirmatory study of the Treatment Target Group (TTG) population was based on discussions with the FDA, and will provide sufficient information in this population for an NDA filing,” said Tina Shogen, Alfacell’s CEO.
Study results were analyzed using criteria developed by the CALGB (Cancer and Leukemia Group B), a national cooperative oncology group, which has conducted mesothelioma research since the 1980′s. Response and survival rates in MM have been historically difficult to assess.
“Alfacell’s confirmation of the value of the six CALGB prognostic groups as a tool for prospectively identifying comparable patient populations and its confirmation of the value of the survival advantage of the stable disease category represents an important scientific contribution to mesothelioma patient care,” said Dr. Nicholas Vogelzang, Director, University of Chicago Cancer Research Center, Fred C. Buffett Professor of Medicine and former chairman of the mesothelioma subcommittee of the CALGB.
As reported at the American Society of Clinical Oncology (ASCO) 2000, ONCONASE was equivalent to the potent chemotherapy drug, doxorubicin in controlling growth of malignant mesothelioma. In a subset analysis, the TTG patients treated with this novel anti-cancer drug exhibited a two-month median survival advantage compared to doxorubicin. In addition, 1-year and 2-year survival rates favored ONCONASE-treated patients.
As published in the January 1, 2002 issue of the Journal of Clinical Oncology, clear anti-tumor activity was seen in 6 of the 81 evaluable patients and an additional 35 patients had cessation of growth in previously growing mesothelioma. In spite of the fact that 24 of the 105 patients entered were in prognostically poor groups, the median survival of the patients who entered the trial without symptoms from the cancer was 18.5 months. Over 1300 doses of the drug were administered and there were no drug-related deaths in this elderly population. Furthermore, ONCONASE demonstrated anti-mesothelioma activity even in the face of prior chemotherapy.
In February 2001, ONCONASE was granted Orphan Medicinal Product Designation in Europe for the treatment of patients with malignant mesothelioma and Alfacell is planning to register ONCONASE in Europe, and then in the U.S. Epidemiologists have predicted that over 250,000 people will die from MM in Europe alone, in the next 35 years.