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

tumors and that perifosine may have antitumor clinical activity as a single agent in neuroblastoma. Additionally, in a preclinical study recently published in the Journal of the National Cancer Institute, perifosine showed a statistically significant reduction in neuroblastoma cell survival, slowed or regressed tumor growth, and increased survival in mice bearing neuroblastoma tumors.

A decreased level of activated Akt was also observed in perifosine-treated neuroblastoma cells and xenograft tumors.

About Perifosine

Perifosine, a novel, potentially first-in-class, oral Akt inhibitor, is currently in Phase 3 trials in the United States for advanced colorectal cancer and multiple myeloma, under Special Protocol Assessment and Fast Track designation granted by the FDA for both indications. FDA has also granted perifosine orphan-drug designation for multiple myeloma and neuroblastoma. In Europe, the European Medicines Agency ("EMA") has issued positive Scientific Advice for perifosine in multiple myeloma and colorectal cancer, as well as positive opinion for Orphan Medicinal Product designation for perifosine in multiple myeloma.

Perifosine is also in a Phase 1 trial in pediatric patients, as well as in other Phase 1 and Phase 2 trials for several other tumor types.

About Orphan-Drug Designation

Orphan-drug designation is granted by the FDA Office of Orphan Drug Products to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. The designation provides the drug developer with a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication or if it demonstrates superior safety, efficacy, or a maj
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SOURCE AETERNA ZENTARIS INC.
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