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- Posted Thursday November 1, 2012
TESARO and Virginia G. Piper Cancer Center announce enrollment of first patient in clinical trial of TSR-011
Company plans to expand Phase 1/2 clinical trial of the Anaplastic Lymphoma Kinase (ALK) Inhibitor, TSR-011, to multiple clinical trial sites
November 1, 2012
Inc. (Nasdaq: TSRO) announced today that the first clinical
trial of its proprietary Anaplastic Lymphoma Kinase (ALK)
inhibitor, TSR-011, has commenced with the dosing of the first
patient at the Virginia G. Piper Cancer Center Clinical Trials at
Scottsdale Healthcare, a partnership between Scottsdale Healthcare
and the Translational Genomics Research Institute (TGen).
TSR-011 is an orally available ALK inhibitor (targeted anti-cancer
agent) that will be studied in patients, including non-small cell
lung cancer (NSCLC) patients, with ALK+ tumors. TESARO plans
to expand the Phase 1/2 clinical trial of TSR-011 to multiple
clinical trial sites in the U.S. and Europe.
"TSR-011 has the profile of a promising targeted anti-cancer agent
and we are enthusiastic about the opportunity to investigate its
potential in patients," said Dr. Glen Weiss, Director of Thoracic
Oncology at the Virginia G. Piper Cancer Center Clinical Trials at
Scottsdale Healthcare and Clinical Associate Professor at TGen.
Following identification of the maximum tolerated dose of TSR-011
in patients with advanced cancer during the dose escalation phase
of the trial, TESARO plans to evaluate TSR-011 in three parallel
cohorts of patients in the phase 2 portion: those with ALK+ NSCLC
who have not been previously treated with ALK inhibitors, those
with NSCLC who have progressed during treatment with other ALK
inhibitors, and those with other tumor types expressing ALK.
"We are very pleased to have progressed TSR-011 into a human
clinical trial and look forward to identifying a dose that may be
utilized in the expansion phase of the study which will assess both
the safety and efficacy of the compound," said Mary Lynne Hedley,
Ph.D., TESARO's President and Chief Scientific Officer. "ALK
is a key driver of subsets of NSCLC, and may also contribute to the
growth of neuroblastoma, lymphoma and other cancers. In order
to maximize the commercial potential of TSR-011, we plan to study
TSR-011 in multiple treatment and tumor settings."
About Anaplastic Lymphoma Kinase and Non-Small Cell Lung
Cancer
ALK gene fusions that result in constitutive activation of ALK are
associated with sub-sets of certain cancers including non-small
cell lung cancer (NSCLC). Abnormal ALK proteins are also
associated with sub-populations of other cancers including lymphoma
and neuroblastoma. ALK is generally not expressed in normal
adult tissue and therefore represents a promising molecular target
for the development of a cancer therapeutic.
According to the American Cancer Society, over 1.6 million new
lung cancer cases are identified worldwide annually, of which over
200,000 of these new lung cancer cases are in the United
States. Lung cancer is the leading cause of cancer death in
men and the second leading cause of cancer death in women. Lung
cancer is typically divided into two groups based upon the
histologic appearance of the tumor cells-small cell and non-small
cell lung cancer, each of which is treated with distinct
chemotherapeutic approaches. According to the American Cancer
Society, NSCLC accounts for approximately 85% of lung cancer cases,
with approximately 75% of these patients being diagnosed with
metastatic or advanced disease. Despite the introduction of new
therapies patients with locally advanced or metastatic NSCLC have
five-year survival rates of just 24% and 4%, respectively,
according to the Surveillance Epidemiology and End Results program
of the National Cancer Institute. ALK is believed to be a key
driver of tumor development in approximately 5% of all NSCLC
patients.
About the Virginia G. Piper Cancer Center at Scottsdale
Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare
opened in 2001 as the first major cancer center in greater Phoenix,
offering comprehensive cancer care and research through Phase I
clinical trials, diagnosis, treatment, prevention and support
services in collaboration with leading researchers and community
oncologists. The Scottsdale Healthcare cancer program holds
Accreditation with Commendation from the Commission on Cancer of
the American College of Surgeons. Scottsdale Healthcare is the
nonprofit parent organization of the Virginia G. Piper Cancer
Center at Scottsdale Healthcare, Scottsdale Healthcare Research
Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale
Healthcare Shea Medical Center and Scottsdale Healthcare Thompson
Peak Hospital. For more information, visit www.shc.org.
Press Contact:
Jamie Grim
Public Relations Coordinator
Virginia G. Piper Cancer Center
+1.480-323-1387
[email protected]
About TGen
The Translational Genomics Research Institute (TGen) is a Phoenix,
Arizona-based non-profit organization dedicated to conducting
groundbreaking research with life changing results. Research at
TGen is focused on helping patients with diseases such as cancer,
neurological disorders and diabetes. TGen is on the cutting edge of
translational research where investigators are able to unravel the
genetic components of common and complex diseases. Working with
collaborators in the scientific and medical communities, TGen
believes it can make a substantial contribution to the efficiency
and effectiveness of the translational process. For more
information, visit: www.tgen.org.
Press Contact:
Steve Yozwiak
TGen Senior Science Writer
+1.602-343-8704
[email protected]
About TESARO
TESARO, Inc. is an oncology-focused biopharmaceutical company
dedicated to improving the lives of cancer patients.
Forward Looking Statements
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. Examples of forward looking statements contained
in this press release include, among others, statements regarding
our expectations for expanding our Phase 1/2 clinical trial with
TSR-011. Forward-looking statements in this release 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, development
progress of our companion diagnostics, and other matters that could
affect the availability or commercial potential of our drug
candidates or companion diagnostics. 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
Prospectus filed with the Securities and Exchange Commission on
June 29, 2012.
The TESARO, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13456
For further information contact:
Richard Rodgers
Executive Vice President & CFO
+1.339.970.0903
[email protected]