LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE:PBYI), a development stage
biopharmaceutical company, announced that it initiated a 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 Phase II basket trial 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 HER2 mutations. The study
will initially include 6 cohorts (baskets) of patients, each of which
will include one of the following cancers: (1) bladder/urinary tract
cancer; (2) colorectal cancer; (3) endometrial cancer; (4)
gastric/esophageal cancer; (5) ovarian cancer; and (6) all other solid
tumors (including prostate, melanoma and pancreatic cancer). Each basket
will initially consist of 7 patients. If a certain predetermined
objective response rate is seen in the initial cohort of 7 patients, the
basket will be expanded to include a larger number of patients.
“It is estimated that approximately 2-10 percent of patients with solid
tumors have a HER2 mutation. Preclinical data suggests that neratinib
potently inhibits the activity of these cancer-driving mutations, which
could translate into clinical benefit for these patients. We are pleased
to initiate this basket study in order to further investigate the
efficacy of neratinib in these patients with a particular unmet medical
need,” said Alan H. Auerbach, Chief Executive Officer and President of
Puma. “We anticipate that we may get an initial indication on the
efficacy of neratinib in these mutation-positive patients by late this
year or early next year and that we may be able to expand this trial
with additional patients and additional cohorts during that same time
period.”
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 metastatic 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, 2012. 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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