Pharmion will use phase 3 results to file MAA for thalidomide

By Lisa Kerner

Erie, Pa., Jan. 10 - Pharmion Corp. said results of a pivotal phase 3 multiple myeloma trial will form the basis of its Marketing Authorization Application for thalidomide in the treatment of multiple myeloma in Europe. The phase 3 results were announced by Celgene Corp.

The application is expected to be filed by early 2007, pending additional data review and communication with the European regulatory authorities, according to a company news release.

The multi-centered, randomized, placebo-controlled phase 3 study compared the combination of thalidomide plus dexamethasone versus dexamethasone alone as induction therapy for previously untreated multiple myeloma. A total of 270 patients with previously untreated multiple myeloma were randomized to receive thalidomide plus dexamethasone or placebo plus dexamethasone alone.

Celgene said that the study, jointly funded by Pharmion, met the pre-specified interim endpoint for efficacy.

Time to disease progression, the primary endpoint of the phase 3 trial, was found to be 75.7 weeks versus 27.9 weeks, plus progression-free survival of 55.7 weeks versus 24.3 weeks in patients receiving Thalomid plus dexamethasone compared to patients receiving dexamethasone alone.

Patients treated with thalidomide and dexamethasone had an increase in side effects which included insomnia, tremors, dizziness, peripheral neuropathy and constipation. A small percentage of patients reported grade 3 or 4 adverse effects, including deep vein thrombosis and pulmonary embolism.

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. The cause of the disease is unknown.

Pharmion, based in Boulder, Colo., is a pharmaceutical company focused on acquiring, developing and commercializing products for the treatment of hematology and oncology patients.

Celgene, a Summit, N.J.-based pharmaceutical company, is engaged in the discovery, development and commercialization of therapies to treat cancer and immunological diseases.

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