Dendreon Corporation reported that the company's therapeutic vaccine for multiple myeloma, Mylovenge has been granted orphan drug status by the U.S. Food and Drug Administration (FDA).

Orphan drug designation by the FDA is designed to encourage research and development of new therapies for diseases that affect fewer than 200,000 people in the United States. In receiving orphan drug status for Mylovenge, Dendreon is eligible for tax credits for related clinical development costs and assistance from the FDA to facilitate the regulatory review and approval process.

Multiple myeloma is a cancer of the blood characterized by the spread of cancerous B-Lymphocytes that lead to damage to normal cells and bone. Current treatments for multiple myeloma include chemotherapy and bone marrow transplant. More than 40,000 Americans currently have multiple myeloma. The American Cancer Society estimates that over 14,000 new cases of multiple myeloma will be diagnosed in 2002 in the United States and nearly 11,000 individuals will die from the disease.

"We are pleased to receive orphan drug status for Mylovenge and continue our ongoing efforts to explore the utility of this vaccine for treating B-cell malignancies such as multiple myeloma," said David Urdal, Ph.D., president and chief scientific officer of Dendreon.

Mylovenge is currently in Phase II clinical trials. Preliminary results of two recently completed clinical trials suggest that Mylovenge treatment is safe, and that it may stimulate immune activity and cause disease regression or stabilization.

Dendreon Corporation is dedicated to the discovery and development of novel products for the treatment of cancer through its innovative manipulation of the immune system. In addition to Mylovenge, Dendreon has two other therapeutic cancer vaccine candidates in clinical trials -- ProvengeTM, for the treatment of prostate cancer, in Phase III trials; and APC8024, for the treatment of breast, ovarian and colon cancers, in Phase I trials. Dendreon's product pipeline also includes monoclonal antibodies and a pathway to small molecules.