Dendreon Announces Presentation Of Preliminary Data From Phase II STAND Study

(RTTNews) - Dendreon Corp. (DNDN) 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 or BRPC at high risk for metastases.

The company stated that the data will be presented at the 29th Annual European Association of Urology or EAU Congress taking place from April 11-15, 2014 in Stockholm, Sweden.

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.

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 said it plans to make PROVENGE commercially available in Europe, beginning with Germany and the United Kingdom, through Centers of Excellence.

The company noted that PROVENGE should be delayed in patients with active systemic infection until resolution and used with caution in patients with a history of embolic and thrombotic events, including cerebrovascular disease and cardiovascular disorders.

Serious adverse reactions reported include acute infusion reactions (occurring within 1 day of infusion), catheter sepsis, staphylococcal bacteremia, myocardial infarction and cerebrovascular events.