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Dendreon Begins Enrollment in Phase 2 Neu-ACT Trial for Second Active Cellular Immunotherapy Product Candidate, DN24-02 PDF Print E-mail
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Monday, 17 October 2011 20:25

Dendreon Corporation (Nasdaq: DNDN) today announced that the company has begun enrolling patients into a Phase 2 trial for DN24-02, Dendreon’s investigational active cellular immunotherapy being evaluated for the treatment of HER2 positive cancer. The multicenter trial called Neu-ACT (NEU Active Cellular immunoTherapy) is expected to enroll approximately 180 patients to evaluate the safety and efficacy of DN24-02 as adjuvant therapy in patients with high risk HER2 positive invasive urothelial carcinoma, including bladder cancer, following surgical resection.

“We believe that our active cellular immunotherapy platform may have applications in the treatment of other cancers, and are pleased to offer patients and physicians access to DN24-02 through our Phase 2 Neu-ACT clinical trial,” said Mark Frohlich, M.D., executive vice president of research and development and chief medical officer. “Initiating a Phase 2 clinical trial to evaluate immunotherapy outside of the treatment of prostate cancer is a significant milestone for Dendreon, and we look forward to the outcome of this important study.”

Neu-ACT is a multicenter, open-label, Phase 2 study. Patients will be randomized to receive either the investigational product, DN24-02, or standard of care. The primary endpoint of the trial will be to evaluate overall survival between these two groups of patients. Other objectives of the study are to evaluate safety, disease-free survival, and immune response to treatment with DN24-02. Additional information is available at http://clinicaltrials.gov.

“Immunotherapy has great potential to offer breakthroughs in cancer care. In fact, bladder cancer recurrence rates have already seen a profound impact by immune manipulation. We are pleased to continue to lead this evolving field by participating in this Phase 2 trial clinical trial of DN24-02,” said John Corman, M.D., Medical Director of the Virginia Mason Cancer Institute in Seattle and clinical investigator for the Neu-ACT program. “Given the promise of immunotherapy, this is an important step forward for patients with this complex disease.”

Approximately 30 sites across the U.S. will participate in the Phase 2 Neu-ACT trial, including the following sites currently enrolling patients:

  • Virginia Mason Medical Center, Seattle, Washington
    Contact: Kathryn Dahl, 206-341-0578, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: John Corman, M.D.
  • Columbia University Medical Center, New York, New York
    Contact: Katherine Resto-Garces, 212-304-5522, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: Dan Petrylak, M.D.
  • Fox Chase Cancer Center, Philadelphia, Pennsylvania
    Contact: Charlotte Cione, RN, 215-728-3614, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: Elizabeth Plimack, M.D.
  • The Urology Center of Colorado, Denver, Colorado
    Contact: Candice Fortuna-Smith, 303-421-5783, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: Lawrence Karsh, M.D.
  • University of Chicago Medical Center, Chicago, Illinois
    Contact: Toni Mazurek, 773-834-0669 or 855-702-8222, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: Peter O'Donnell, M.D.
  • Indiana University, Indianapolis, Indiana
    Contact: Rhonda Loman, 317-274-0101, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: Thomas Gardner, M.D.
  • Duke University, Durham, North Carolina
    Contact: Trish Creel, 919-668-0635, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: Michael Harrison, M.D.
  • Providence Medical Center, Portland, Oregon
    Contact: Katrina Herz, 503-215-2617, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Contact: Scot Lary, 503-215-2604, This e-mail address is being protected from spambots. You need JavaScript enabled to view it
    Principal Investigator: Brendan Curti, M.D.

About Dendreon

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/.

This news release contains forward-looking statements that are subject to risks and uncertainties.Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon’s business and prospects, including progress on the commercialization efforts for PROVENGE.Information on the factors and risks that could affect Dendreon’s business, financial condition and results of operations are contained in Dendreon’s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release.All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

 
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