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Onconase® Granted Orphan Drug Status for Mesothelioma Treatment
BLOOMFIELD, NJ — February 9, 2007 — The Food and Drug Administration has granted “orphan drug status” to the chemotherapy drug Onconase® (ranpirnase) for use as a mesothelioma treatment. This designation allows the maker of Onconase®, Alfacell, to pay reduced filing fees, obtain tax credits and exclusively market the drug for seven years. The FDA grants orphan drug status to medicines that it considers to be promising for the treatment of rare diseases.
Onconase® is a ribonuclease, which is an enzyme that speeds up the breakdown of RNA, a nucleic acid that copies genetic information and translates it into proteins. Onconase® may inhibit cancer cell growth by interrupting protein synthesis.
In a preliminary study by Alfacell, 105 mesothelioma patients were treated with Onconase®. Their one–year and two–year survival rates were 34.3% and 21.6 %, respectively (J Clin Oncol. 2002 Jan 1; 20(1): 274–81). This compares well with the usual survival rate of 6 to 8 months without treatment.
Alfacell is now conducting a more advanced mesothelioma study at 40 medical centers in seven countries, including the United States and Canada. This is a phase III clinical trial, a study that gathers information about the overall benefits and risks of a drug. A phase III clinical trial involves a large group of volunteers, and is conducted only after initial studies have been done on smaller groups and on animals.
In this case, the researchers are comparing the health of mesothelioma patients using Onconase® plus doxorubicin with those who are using doxorubicin alone. Doxorubicin is a standard chemotherapy medication.
To be eligible for the clinical trial, patients must be at least 21 years old and their cancer must not have spread from the original (primary) tumor to the central nervous system. Their medical history may not include any treatment with doxorubicin or with another chemotherapy drug taken within six weeks of enrolling in the trial.
Further details about the clinical trial are contained on the National Cancer Institute web site, Clinical Trials PDQ®, and on CenterWatch, a clinical trials listing service. To learn more about chemotherapy, see Mesothelioma Treatment: Chemotherapy and New Drug Research and Mesothelioma Treatment: Side Effects of Chemotherapy.
If you or a loved one has been diagnosed with mesothelioma, please feel free to contact us at Brayton Purcell to learn about your legal choices. We have been handling cases involving mesothelioma and asbestos exposure for over 24 years and can provide support, information, and excellent advocacy.
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