DNDN..tough news...
SAN FRANCISCO, CA, January 11, 2005 - Dendreon Corporation (Nasdaq: DNDN) today announced at the 23rd Annual JPMorgan Healthcare Conference that preliminary data from its D9902A study of Provenge®, the Company's investigational immunotherapy for the treatment of advanced prostate cancer.
The final analysis of the primary endpoint, time to disease progression, in D9902A did not show a statistically significant delay in time to disease progression in the overall group or in the Gleason score subgroups. An interim analysis of overall survival in the intent-to-treat patient population, the secondary endpoint of the D9902A study, indicated that both the survival rates and the median survival benefit compared to placebo are similar to the results observed in the final three-year survival analysis of the D9901 study (link) reported in October 2004. The results from the D9901 study demonstrated a survival benefit in the overall intent-to-treat patient population. The Company plans to complete the final pre-specified, three-year survival analysis of the D9902A study in the second half of 2005. As in previous studies, Provenge was generally well tolerated.
"We are encouraged that the interim survival rates and the median survival benefit are similar to those observed in the D9901 study," said Robert Hershberg, M.D., Ph.D., senior vice president and chief medical officer at Dendreon Corporation. "While D9902A is a relatively small study, we believe the data will contribute to the large body of information we have from the multiple clinical trials of Provenge. We intend to utilize these data in our ongoing discussions with the FDA to determine the most expeditious route to obtain potential regulatory approval of Provenge."
The Company also announced that the final D9901 results, including the three-year survival data, will be presented in an oral presentation at the American Society of Clinical Oncology's 2005 Prostate Cancer Symposium in Orlando, February 17th - 19th.
The D9902A study was a double-blind, placebo-controlled Phase 3 study of Provenge in patients with asymptomatic, metastatic, androgen-independent prostate cancer. D9902A was originally designed to be the companion study to Dendreon's completed first Phase 3 study, D9901. The D9902A study was stopped in 2002 after 98 patients were enrolled when the analysis of D9901 showed that no significant benefit in time to disease progression had been observed in the overall group, but that a benefit was seen in the subgroup of patients with Gleason scores of seven and less. The Company amended the D9902A protocol to become what is the ongoing D9902B pivotal Phase 3 study.
Prostate cancer is the number one non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 220,000 new cases of prostate cancer diagnosed each year. More than 30,000 men die each year of the disease.
Dendreon will present today at the 23rd Annual JPMorgan Healthcare
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