LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage
biopharmaceutical company, announced the initiation of a Phase II trial
of Puma's investigational drug PB272 (neratinib) for the extended
adjuvant treatment of breast cancer.
The 70 patient study will be an open label single arm Phase II trial of
PB272 monotherapy administered to patients with HER2-positive early
stage breast cancer who have previously received adjuvant treatment with
trastuzumab. Patients will receive extended adjuvant treatment with
neratinib for a period of one year. Patients will receive primary
prophylaxis with high dose loperamide (16 mg per day initially) in order
to attempt to reduce the neratinib-related diarrhea. The primary
endpoint of the trial is reduction in the incidence and severity of
diarrhea.
“We are pleased to initiate this Phase II trial,” said Alan H. Auerbach,
Chief Executive Officer and President. “Because the ExteNET Phase III
trial was run prior to the implementation of loperamide prophylaxis in
clinical trials of neratinib, in the ExteNET Phase III trial neratinib
was administered without loperamide prophylaxis. The results from this
Phase II study will give us a better understanding of the safety of
neratinib in the extended adjuvant setting with concurrent high dose
loperamide administered and, importantly, to what degree the grade 3
neratinib-related diarrhea can be reduced. We anticipate that initial
results from this trial should be available by yearend 2015 and would
enable us to include this data in our NDA filing for neratinib in the
extended adjuvant setting, which is currently anticipated for the first
quarter of 2016."
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 regulatory filings and 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, 2014. 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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