- Final Phase 1 Results Demonstrate Activity in Ovarian and Breast Cancer
- Phase 3 Trial in Ovarian Cancer to Begin Enrolling Patients by Mid-Year
- Phase 3 Trial in Patients With Breast Cancer on Track to Initiate in 2H13
WALTHAM, Mass., May 16, 2013 (GLOBE NEWSWIRE) -- TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that final results from a Phase 1 trial of niraparib, an inhibitor of poly ADP-ribose polymerase (PARP), will be presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. These results include anti-tumor activity and safety data for 100 patients with solid tumors, including 49 patients with high grade serous ovarian cancer (HGSOC) and twelve patients with breast cancer. Full, updated results relating to the abstract will be provided during the investigators' poster presentation on June 4, 2013.
"We are pleased that these data confirm the preliminary results presented at ASCO in 2011, and support advancement of niraparib into Phase 3 trials," stated Dr. Mary Lynne Hedley, President of TESARO. "We remain on track to begin enrolling patients in a Phase 3 trial in the ovarian cancer maintenance setting by mid-year, and to initiate a Phase 3 trial in patients with breast cancer during the second half of 2013."
TESARO will host an investor briefing in Chicago on Sunday, June 2 at 6:15 PM local time in conjunction with the ASCO annual meeting. At this briefing, TESARO management will review niraparib clinical data, discuss development plans in ovarian and breast cancer and answer questions from analysts and investors. This event will be webcast live and archived for 30 days at www.tesarobio.com.
ASCO Data Presentation Details
Final Results of the Phase I Trial of Niraparib (MK4827), a Poly(ADP)ribose Polymerase (PARP) Inhibitor Incorporating Proof of Concept Biomarker Studies and Expansion Cohorts Involving BRCA1/2 Mutation Carriers, Sporadic Ovarian and Castration Resistant Prostate Cancer (CRPC), Poster #2513, June 4, 2013 from 8:00 AM to 12:00 PM; 11:30 AM discussion
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
To the extent that statements contained in this press release are not descriptions of historical facts regarding TESARO, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation of future clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of our drug candidates. TESARO undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see TESARO's Form 10-K for the year ended December 31, 2012.
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