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SOURCE: Alfacell Corporation
ONCONASE ® Receives Fast Track Designation From FDA for Malignant Mesothelioma Therapy
BLOOMFIELD, N.J., Dec. 19 /PRNewswire-FirstCall/ -- ALFACELL Corporation today announced that the U.S. Food and Drug Administration (FDA) has reviewed Alfacell's Investigational New Drug (IND) Application for the treatment of malignant mesothelioma (MM) patients with ONCONASE ® (ranpirnase), together with the chemotherapy doxorubicin, and has concluded that such application meets the criteria for Fast Track designation. Alfacell filed an application with the FDA for this designation on October 23, 2002. Fast Track represents a formal mechanism to interact with the FDA using approaches that are available to all applicants for marketing claims.
The benefits of Fast Track include scheduled meetings seeking FDA input into development plans, the option of submitting a New Drug Application (NDA) in sections rather than submitting all components simultaneously, and the option of requesting evaluation of studies using surrogate endpoints. The Fast Track designation, which is intended for the combination of a product and a claim that addresses an unmet medical need, is independent of the FDA's priority review and accelerated approval mechanisms.
Malignant mesothelioma is distinctly different from other forms of lung cancer. It originates from the mesothelial cells in the lining of the lung, heart, abdominal or pelvic cavities, and occurs primarily in male adults.
Symptoms reported by patients at the time of diagnosis typically include chest/abdominal pain, breathing difficulty, recent weight loss, anorexia and/or fatigue. Although the typical survival of patients with inoperable MM is 6 to 9 months from diagnosis, a large number die within 3 to 4 months, and few survive beyond 2 years. There is no approved global therapy for MM.
Causes of MM have been linked, in a majority of cases, to asbestos exposure, and this has resulted in a worldwide effort to limit or prevent exposure to asbestos. However, due to a latency of 20 to 50 years between asbestos exposure and symptoms of the disease, the impact of this effort will not affect MM incidence for several decades. Epidemiologists have predicted that over 250,000 people will die from MM in Europe alone during the next 35 years.
In February 2001, ONCONASE was granted Orphan Medicinal Product Designation in Europe for the treatment of patients with malignant mesothelioma.
Over forty sites in the US, Germany, and Italy are participating in Alfacell's International Malignant Mesothelioma Program. For more information concerning participation in the Company's International Malignant Mesothelioma Program, please contact Alfacell at patientinfo@alfacell.com.
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