LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE:PBYI), a development stage
biopharmaceutical company, announced the initiation of its Phase III
clinical trial of the Company's lead drug candidate PB272 (neratinib) in
patients with HER2-positive metastatic breast cancer who have failed two
or more prior treatments (third-line disease).
The Phase III trial will be a randomized trial of PB272 plus Xeloda
versus Tykerb plus Xeloda in patients with third-line HER2-positive
metastatic breast cancer. The trial is expected to enroll approximately
600 patients who will be randomized (1:1) to receive either PB272 plus
Xeloda or Tykerb plus Xeloda. The trial will be conducted at
approximately 150 sites in North America, Europe and Asia-Pacific. The
co-primary endpoints of the trial are progression free survival and
overall survival. The Company plans to use the progression free survival
data from the trial, which is being conducted under a Special Protocol
Assessment (SPA) agreement with the U.S. Food and Drug Administration,
as the basis for submission of a New Drug Application (NDA) to the FDA
for accelerated approval of PB272 for this indication. The Company also
plans to use the progression free survival data from this trial to
support a Market Authorization Application (MAA) to the European
Medicines Agency for conditional approval for PB272 in the same
indication.
Alan H. Auerbach, Chief Executive Officer and President of Puma
Biotechnology, said, "Commencing the Phase III trial of PB272 in
HER2-positive metastatic breast cancer represents an important milestone
in the global development of PB272 and for Puma as a company. We look
forward to aggressively enrolling this trial and to pursuing additional
registration opportunities for PB272 in HER2-positive breast cancer and
in tumors with a mutation in the HER2 kinase, including non-small cell
lung cancer, breast cancer and the other solid tumors that we will be
studying in our upcoming basket trial."
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 (neratinib), an oral
potent irreversible tyrosine kinase inhibitor, for the treatment of
patients with HER2 positive metastatic breast cancer and non-small cell
lung cancer.
Further information about Puma Biotechnology can be found at www.pumabiotechnology.com.
Forward-Looking Statements:
This press release contains forward-looking statements that 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 its lead drug candidate, 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
from time to time in the Company's filings with the Securities and
Exchange Commission, including the Company’s Annual Report on Form 10-K
for the year ended December 31, 2012 and Quarterly Report on Form 10-Q
for the Quarter Ended March 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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