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Dendreon Says Prelim. Data from LT Phase II STAND Study Will Be Presented at EAU Congress, Will Show Immune Responses with PROVENGE Enhanced, Sustained

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Dendreon Corporation (NASDAQ: DNDN) today announced the presentation of preliminary data from a long-term analysis of the Phase II STAND study demonstrating that tumor-specific T-cell responses appear to be enhanced and sustained when PROVENGE^® (sipuleucel-T) is given after androgen deprivation therapy (ADT) in patients with biochemically-recurrent prostate cancer (BRPC) at high risk for metastases. These data will be presented at the 29^th Annual European Association of Urology (EAU) Congress taking place from April 11-15, 2014 in Stockholm, Sweden.^1

“We are pleased with the preliminary STAND data, which show the continued potential for sequencing PROVENGE with other treatments and the impact that immunotherapy has on immune responses in advanced prostate cancer patients,” said Andrew S. Sandler, M.D., executive vice president and chief medical officer at Dendreon. “The presentation of these data at EAU highlights Dendreon's commitment to expanding awareness and understanding of immunotherapy and PROVENGE in Europe as we prepare to make PROVENGE available to advanced prostate cancer patients beyond the United States.”

ADT is a standard treatment option for men with BRPC after failure of local therapy. The STAND study is a randomized, Phase II trial that consisted of two patient study groups, one completing PROVENGE two weeks before ADT and the second receiving PROVENGE three months after the start of ADT. Preliminary results suggest enhanced cellular immune responses when PROVENGE was given after ADT, and these responses were persistent for at least 12 months and robust in both patient groups.

“The STAND study results are encouraging as they provide additional evidence on how sipuleucel-T can be sequenced with other treatments which will assist clinician decision-making upon whether immune responses correlate with certain clinical parameters, such as prostate specific antigen (PSA) recurrence,” said Neal Shore, M.D., medical director at the Carolina Urologic Research Center.

PROVENGE is approved in all 28 countries of the European Union (EU) as well as Norway, Iceland and Liechtenstein for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. Dendreon plans to make PROVENGE commercially available in Europe, beginning with Germany and the United Kingdom, through Centers of Excellence.

 

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