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Aeterna Zentaris Announces Perifosine Has Received Orphan-Drug Designation for the Treatment of Neuroblastoma
Date:7/14/2010

or contribution to patient care versus another drug of its type previously granted the designation for the same indication, as well as with tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

About Neuroblastoma

According to the American Cancer Society, neuroblastoma is the most common cancer in infants (less than 1 year old) and accounts for about 7% of all pediatric cancers. There are about 650 new cases of neuroblastoma each year in the United States, and, while in rare cases neuroblastoma is detected by ultrasound in utero, the average age at the time of diagnosis is approximately 1 to 2 years, with 90% of cases diagnosed before age 5. In about 2 of 3 cases, the disease has already spread (metastasized) to other parts of the body at the time of diagnosis and as a result, treatment options can be limited.

Neuroblastoma exhibits a wide range of behavior. Some infant neuroblastomas may just go away without treatment (spontaneously regress), while other neuroblastomas may be resistant to very intensive multimodal treatment, and, in these cases, neuroblastoma is considered to be one of the most aggressive and difficult to cure childhood cancers.

To date, no FDA approved therapies exist for the treatment of neuroblastoma. Chemotherapy is the mainstay of neuroblastoma treatment. The type of chemotherapy and its intensity are determined by the age of the patient and the extent of the disease (risk-factors). However, because these cancers can be hard to treat, additional therapies are needed in order to delay progression and extend survival.

About Aeterna Zentaris Inc.

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5. Aeterna Zentaris Receives Positive Opinion for Orphan Medicinal Product Designation for AEZS-108 for the Treatment of Ovarian Cancer from the Committee for Orphan Medicinal Products of the European Medicines Agency
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