Press Release Source: Dendreon Corporation
Dendreon Announces Results of D9905 Phase 2 Study of Provenge in Patients with Early Stage Prostate Cancer
Tuesday May 24, 9:00 am ET
Data Presented at the American Urological Association Annual Meeting in San Antonio
SAN ANTONIO, May 24 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN - News) today announced results of an open-label Phase 2 study of Provenge® (APC8015) as a mono-therapy in men with rising PSA post definitive local therapy (androgen-dependent prostate cancer). Provenge is the Company's investigational immunotherapy for the treatment of prostate cancer. The study, referred to as D9905, suggests that Provenge as a single agent may lead to improved PSA doubling time (PSADT) in patients with early stage prostate cancer. PSADT is the time it takes for the prostate-specific antigen (PSA) value to double. This is used to help predict the possibility of metastasis and time to death in early stage prostate cancer. The data were presented at the American Urological Association annual meeting here today.
"We are very encouraged by the findings of this study investigating the use of Provenge as a mono-therapy in men with earlier stage prostate cancer," said Robert M. Hershberg, M.D., Ph.D., Dendreon's chief medical officer. "We believe Provenge may have the potential to alter the course of treatment in early stage prostate cancer and may offer a compelling alternative to either watchful waiting or the use of androgen ablation therapy in this early stage of disease recurrence. We look forward to completing enrollment of our ongoing large Phase 3 study P-11 very soon, which is examining Provenge in patients with androgen-dependent prostate cancer."
Study Details and Results
During the meeting, researchers presented data from a poster entitled, "Immunotherapy (APC8015) for Androgen Dependent, Biochemically-Relapsed Prostate Cancer (D9905)." The data from Study D9905 demonstrated that 71% (12 of 17) of evaluable patients had a prolongation in their PSADT post-treatment with Provenge. After treatment with Provenge, patients had a 52% increase in PSADT (5.2 months to 7.9 months). In addition, in five patients, the post- treatment PSADT was greater than 12 months, with one of these patients showing a 20-fold increase in post-treatment PSADT compared with pre-treatment PSADT (66.6 months vs. 3.5 months). As in previous studies, Provenge also was shown to be generally well tolerated with the most common side effects being fever and chills typically of low grade and short duration.
