DGAP-News: TESARO Initiates Phase 3 Trial of Niraparib for Treatment of Patients With Ovarian Cancer
(firmenpresse) - TESARO, Inc.
23.07.2013 13:01
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First Patient Enrolled in the NOVA Study
WALTHAM, Mass., 2013-07-23 13:01 CEST (GLOBE NEWSWIRE) --
TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company,
today announced that it has initiated patient enrollment in a Phase 3 trial of
niraparib, an inhibitor of poly ADP-ribose polymerase (PARP), for the treatment
of ovarian cancer. This trial, referred to as NOVA, will evaluate a single
daily 300 milligram dose of niraparib in 360 patients with high grade serous,
platinum sensitive, relapsed ovarian cancer compared to placebo.
'We are pleased to open this Phase 3 trial of niraparib to patients with
ovarian cancer,' said Mary Lynne Hedley, Ph.D., President of TESARO. 'This
milestone represents a significant advance in the progression of TESARO's
pipeline and brings us closer to our goal of delivering new oncology therapies
to patients.'
Final results from a Phase 1 trial of niraparib were presented on June 4 at the
American Society of Clinical Oncology (ASCO) annual meeting in Chicago. These
data showed that at the recommended dose, 75% (three of four patients) with
platinum sensitive high grade serous ovarian cancer (HGSOC) achieved a RECIST
response. Across all dose levels (30 milligrams to 400 milligrams daily), a
RECIST response rate of 46% (6/13 patients) was observed in this population. A
RECIST response rate of 50% (5/10 patients) was achieved in patients with
platinum sensitive ovarian cancer and germline BRCA mutations. The median
duration of response was 431 days for platinum sensitive germline BRCA patients
and 444 days for platinum sensitive patients who were not germline BRCA
mutation carriers. The patients with ovarian cancer who were enrolled in this
study had received a median of six previous regimens of systemic therapy.
Niraparib was generally well tolerated at 300 milligrams daily, with a low rate
of grade 3/4 toxicities. The most frequently observed adverse events at the 300
milligram dose included grade 1/2 anemia, fatigue and nausea.
About The NOVA Study
The NOVA (Niraparib Ovarian) study is a 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. More
information about this Phase 3 trial is available at
http://clinicaltrials.gov/show/NCT01847274.
About TESARO
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.
CONTACT: Investor/Media Contact:
Jennifer Davis
Sr. Director, Corporate Development&Investor Relations
+1.781.325.1116 or jdavis(at)tesarobio.com
News Source: NASDAQ OMX
23.07.2013 Dissemination of a Corporate News, transmitted by DGAP -
a company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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