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U.S. health regulators amend trial design of Provenge

FDA has agreed to an amended Special Protocol Assessment for the Phase 3 IMPACT clinical trial of PROVENGE. In addition, the FDA has reconfirmed that they would accept a positive interim or final analysis from the IMPACT trial to amend the Biologics License Application for... read more
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Dendreon Corporation (DNDN) is a biotechnology company with a focus on developing drugs for cancer. Its most advanced product is Provenge (Sipuleucel-T), a therapeutic vaccine candidate being developed for the treatment of prostate cancer. Provenge could have blockbuster potential if the ongoing clinical late-stage trial yields positive results. Dendreon will market Provenge in the U.S. on its own. And we expect Dendreon to announce a partner for Provenge in the rest of the world soon. Another important product under clinical development is APC-8024 (Lapuleucel-T, Neuvenge) for the treatment of breast, ovarian, and colorectal cancers. The company has no products on the market and derives its revenue entirely from collaborations with other companies. Based in Seattle, WA, the company employs nearly 150 people.



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