LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, announced that results of the Phase II
clinical trial of Puma’s investigational drug PB272 (neratinib) for the
neoadjuvant treatment of breast cancer (I-SPY2 TRIAL) will be presented
in an oral presentation at the American Association for Cancer Research
(AACR) Annual Meeting 2014, April 5-9, in San Diego, California. The
presentation entitled “Neratinib plus Standard Neoadjuvant Therapy for
High-Risk Breast Cancer: Efficacy Results from the I-SPY 2 TRIAL” will
be included in the session entitled “Clinical Trials Symposium:
Biomarker Driven Clinical Trials,” which will be held from 10:30 a.m. to
12:30 p.m. PDT on Monday, April 7, in Room 29 at the San Diego
Convention Center.
The I-SPY 2 TRIAL (Investigation of Serial Studies to Predict Your
Therapeutic Response with Imaging And moLecular Analysis 2) is a
randomized Phase II clinical trial for women with newly diagnosed Stage
2 or higher (tumor size at least 2.5 cm) breast cancer that addresses
whether adding investigational drugs to standard chemotherapy in the
neoadjuvant setting is better than standard chemotherapy. The primary
endpoint is pathological complete response (pCR) in the breast and the
lymph nodes at the time of surgery. The goal of the trial is to match
investigational regimens with patient subsets on the basis of molecular
characteristics (referred to as biomarker signatures) that benefit from
the regimen.
The abstracts for the presentations that will be made at the AACR Annual
Meeting 2014 will be available at www.aacr.org.
About Puma Biotechnology
Puma Biotechnology, Inc. is a development stage biopharmaceutical
company that acquires and develops innovative products for the treatment
of various forms of cancer. The Company focuses on in-licensing drug
candidates that are undergoing or have already completed initial
clinical testing for the treatment of cancer and then seeks to further
develop those drug candidates for commercial use. The Company is
initially focused on the development of PB272 (oral neratinib), a potent
irreversible tyrosine kinase inhibitor, for the treatment of patients
with HER2-positive breast cancer and patients with non-small cell lung
cancer, breast cancer and other solid tumors that have a HER2 mutation.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements:
This press release contains forward-looking statements, including
statements regarding anticipated timing for the announcement of data
relative to clinical trials. All forward-looking statements included in
this press release involve risks and uncertainties that could cause the
Company's actual results to differ materially from the anticipated
results and expectations expressed in these forward-looking statements.
These statements are based on current expectations, forecasts and
assumptions, and actual outcomes and results could differ materially
from these statements due to a number of factors, which include, but are
not limited to, the fact that the Company has no product revenue and no
products approved for marketing, the Company’s dependence on PB272,
which is still under development and may never receive regulatory
approval, the challenges associated with conducting and enrolling
clinical trials, the risk that the results of clinical trials may not
support the Company’s drug candidate claims, even if approved, the risk
that physicians and patients may not accept or use the Company’s
products, the Company’s reliance on third parties to conduct its
clinical trials and to formulate and manufacture its drug candidates,
the Company’s dependence on licensed intellectual property, and the
other risk factors disclosed in the periodic reports filed by the
Company with the Securities and Exchange Commission from time to time,
including the Company’s Annual Report on Form 10-K for the year
ended December 31, 2013. Readers are cautioned not to place undue
reliance on these forward-looking statements, which speak only as of the
date hereof. The Company assumes no obligation to update these
forward-looking statements, except as required by law.
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