PROVENGE® (sipuleucel-T) Data Presented at An Annual Scientific Urology Meeting
PROVENGE® (sipuleucel-T) Data Presented at An Annual Scientific Urology Meeting
Three Presentations Inform the Use of PROVENGE in the Metastatic Castrate-Resistant Prostate Cancer Treatment Continuum
May 6, 2013--Dendreon Corporation (NASDAQ: DNDN) today announced the presentation of three PROVENGE® (sipuleucel-T) abstracts from new and ongoing clinical trials at the 2013 American Urological Association (AUA) Annual Meeting from May 4-8, 2013 in San Diego, California.
“The PROVENGE research presented at this year's AUA Annual Meeting reflects Dendreon's ongoing commitment to men in need of new treatment options for advanced prostate cancer,” said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer at Dendreon. "Data from the pivotal Phase III IMPACT trial, the Phase II ProACT study and the Phase IV PROCEED registry provide the healthcare community with a better understanding of the role of PROVENGE in the metastatic castrate-resistant prostate cancer treatment continuum."
Clinical presentations featuring PROVENGE data will be highlighted during a moderated poster session on Monday, May 6 from 10:30 a.m. to 12:30 p.m. PT in Room 11 at the San Diego Convention Center. The abstracts include:
- Abstract #960: E. David Crawford, M.D., professor of surgery, urology, and radiation oncology, and head of the section of urologic oncology at the University of Colorado Denver School of Medicine, will present a poster titled “Optimal Timing for Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): Sequencing and Identifying Parameters of Early Progression with Sipuleucel-T:” In the Phase 3 IMPACT trial, a retrospective subgroup analysis suggested a greater PROVENGE treatment effect in those patients with a lower baseline PSA. These data were recently published in the international journal, Urology.
- Abstract #971: Thomas Gardner, M.D., associate professor in the Department of Microbiology and Immunology at Indiana University School of Medicine, will present a poster titled “Safety and Changes in Laboratory Parameters Associated with Sipuleucel-T in Patients with Metastatic Castration-Resistant Prostate Cancer: Phase II ProACT study:” A Phase II study evaluated immune responses and overall survival of patients receiving PROVENGE manufactured with different concentrations of antigen. Increased globulin protein and transient increased eosinophil counts were consistent with previous studies and positively correlated with immune response and overall survival. The safety profile of PROVENGE was consistent with that observed in previous clinical trials.
- Abstract #972: Matthew Cooperberg, M.D., assistant professor of urology, epidemiology and biostatistics, University of California, San Francisco, will present a poster titled “Treatment Practice Patterns in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Prior to Receiving Sipuleucel-T: Data from PROCEED:” In a Phase IV registry study, data on patients enrolled before they received PROVENGE provides a window into current treatment patterns for patients with advanced prostate cancer and will continue to yield important information that can be used to track trends in patient demographics and treatment prior to and after receiving PROVENGE.
“These presentations at AUA provide the medical community with possible new insight on the role of PROVENGE in men with advanced prostate cancer,” said E. David Crawford, M.D., professor of surgery, urology, and radiation oncology, and head of the section of urologic oncology at the University of Colorado, Denver School of Medicine. “PROVENGE is an innovative treatment option that uses a patient’s own cells to activate the immune system to fight the disease, and these data reinforce what we have seen in the clinical setting.”
Indication and Important Safety Information
PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer.
PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases.
The safety evaluation of PROVENGE was based on 601 prostate cancer patients in four randomized clinical trials who underwent at least one leukapheresis. The most common adverse events (incidence greater-than or equal to 15%) are chills, fatigue, fever, back pain, nausea, joint ache, and headache. Serious adverse events reported in the PROVENGE group include acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. In controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group.
To fulfill a post marketing requirement and as a part of the company's ongoing commitment to patients, Dendreon will conduct a registry of approximately 1500 patients to further evaluate a small potential safety signal of cerebrovascular events. In four randomized clinical trials of PROVENGE in prostate cancer patients, cerebrovascular events were observed in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group.
For the FDA approved full prescribing information, please visit http://www.provenge.com.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon's first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, statements regarding the expected benefits of the restructuring, the timing and elements of the restructuring, the timing and form of related charges, the expected annual operating expense reduction, expectations and beliefs regarding Dendreon's financial position, profitability and Dendreon's ability to break even and achieve improved performance as a result of the restructuring, expectations regarding reductions of cost of goods sold, expectations regarding regulatory approval of PROVENGE® in Europe, expectations regarding the presentation of clinical data, developments affecting Dendreon's U.S. and global business and prospects and potential revenue and earnings from product sales, expectations regarding market size and market opportunity, beliefs regarding the impact of our direct to consumer advertising, expectations with respect to our sales force execution, and progress generally on commercialization efforts for PROVENGE. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Dendreon's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, our inability to achieve and sustain commercial success for PROVENGE; the identification of efficacy, safety or other issues with PROVENGE; a slower than anticipated adoption by treating physicians of PROVENGE for the treatment of patients with advanced prostate cancer due to competing therapies, instability in our sales force, including the risk that we cannot replace vacant sales positions on a prompt basis, perceived difficulties in the treatment process, delays in obtaining reimbursement or for other reasons; any promotional limitations imposed by the FDA on our ability to commercialize and market PROVENGE; unexpected difficulties and costs associated with the rapid expansion of our operations to support the commercial launch of PROVENGE; the impact of competing therapies on sales of PROVENGE, and other factors discussed in the "Risk Factors" section of Dendreon's Annual Report on Form 10-K for the year ended December 31, 2012. All forward-looking statements are qualified in their entirety by this cautionary statement. Dendreon is providing this information as of the date of this press release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
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