Dendreon initiates enrollment in DN24-02 Phase 2 trial for HER2 positive cancer

Oct 18 2011

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, [email protected]
  Principal Investigator: John Corman, M.D.

• Columbia University Medical Center, New York, New York
  Contact: Katherine Resto-Garces, 212-304-5522, [email protected]
  Principal Investigator: Dan Petrylak, M.D.

• Fox Chase Cancer Center, Philadelphia, Pennsylvania
  Contact: Charlotte Cione, RN, 215-728-3614, [email protected]
  Principal Investigator: Elizabeth Plimack, M.D.

• The Urology Center of Colorado, Denver, Colorado
  Contact: Candice Fortuna-Smith, 303-421-5783, [email protected]
  Principal Investigator: Lawrence Karsh, M.D.

• University of Chicago Medical Center, Chicago, Illinois
  Contact: Toni Mazurek, 773-834-0669 or 855-702-8222, [email protected]
  Principal Investigator: Peter O'Donnell, M.D.

• Indiana University, Indianapolis, Indiana
  Contact: Rhonda Loman, 317-274-0101, [email protected]
  Principal Investigator: Thomas Gardner, M.D.

• Duke University, Durham, North Carolina
  Contact: Trish Creel, 919-668-0635, [email protected]
  Principal Investigator: Michael Harrison, M.D.

• Providence Medical Center, Portland, Oregon
  Contact: Katrina Herz, 503-215-2617, [email protected]
  Contact: Scot Lary, 503-215-2604, [email protected]
  Principal Investigator: Brendan Curti, M.D.