LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, has expanded the first cohort from its Phase
II clinical trial of its lead drug candidate PB272 (neratinib) as a
single agent in patients with solid tumors who have an activating HER2
mutation (basket trial). The cohort that has been expanded is the cohort
that includes patients with metastatic breast cancer that is not HER2
amplified or overexpressed (HER2 negative) and has a HER2 mutation.
The Phase II basket trial, which was initiated in October 2013, is an
open-label, multicenter, multinational study to evaluate the safety and
efficacy of PB272 administered daily to patients who have solid tumors
with activating (driver) HER2 mutations. The cohorts (baskets) included
in the study are: (1) bladder/urinary tract cancer; (2) colorectal
cancer; (3) endometrial cancer; (4) gastric/esophageal cancer; (5)
ovarian cancer; (6) EGFR mutated and/or amplified primary brain cancer;
(7) solid tumors with a HER3 mutation, and (8) all other solid tumors
with a HER2 mutation. The breast cancer patients initially entered the
study in the “other solid tumors with a HER2 mutation” basket and due to
the preliminary activity seen in the trial the Company has expanded the
basket, as per the protocol for the trial. The expanded basket will
initially enroll a total of 18 patients.
“We are pleased to expand the first cohort in the basket trial. This
trial will be the second trial that Puma is running in patients with
HER2-negative breast cancer with a HER2 mutation and will be run at many
different centers than the investigator-sponsored trial that was
initiated in December 2012,” said Alan H. Auerbach, Chief Executive
Officer and President of Puma. “We look forward to continuing enrollment
into this initially expanded cohort and look forward to expanding
additional cohorts from the basket trial, which we anticipate being able
to do later this year.”
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 commencement and
completion of various clinical trials and the announcement of data
relative to these 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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