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CHICAGO, June 3, 2013 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, and the European Network of Gynecological Oncological Trial Groups (ENGOT), a network of national and regional clinical trial organizations, today announced a partnership for the Phase 3 clinical development of niraparib, an orally active, potent poly (ADP-ribose) polymerase (PARP) inhibitor.
The collaboration between TESARO and ENGOT will facilitate and promote the Phase 3 clinical trial of niraparib in patients with ovarian cancer at leading European cancer centers. Major goals of this partnership include optimizing the scientific and clinical impact of the Phase 3 protocol design, accelerating and streamlining selection of investigators and clinical site management, and expediting patient enrollment and publication of data from this trial.
"As an organization dedicated to gynecological cancer research and treatment, we look forward to partnering with TESARO to accelerate the development of niraparib for patients with ovarian cancer," said Dr. Mansoor Raza Mirza, Medical Director of the
Nordic Society of Gynecologic Oncology Clinical Trial Unit. "We are pleased to support clinical research initiatives for this innovative and potentially new class of cancer therapeutics."
"We are excited to be working with ENGOT to advance the treatment paradigm for patients with ovarian cancer, where significant unmet medical need still exists," said Dr. Mary Lynne Hedley, President of TESARO. "We look forward to opening this global study to patients in mid-2013 and are pleased to have ENGOT supporting enrollment at key European trial sites."
This double blind, placebo-controlled, international Phase 3 trial of niraparib is planned to enroll 360 patients with high grade serous, platinum sensitive, relapsed ovarian cancer. Patients will enroll into one of two independent cohorts based on germline BRCA mutation status. Within each cohort, patients will be randomized 2:1 to receive niraparib or placebo, and will be continuously treated with placebo or 300 milligrams of niraparib until progression. The primary endpoint of this study is progression free survival. Secondary endpoints include patient reported outcomes, chemotherapy free interval length, and overall survival.