LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, has
expanded the third 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 biliary duct (bile duct) cancer and whose tumors have 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) ERBB mutations including EGFR, HER2 and HER3.
The cohorts (baskets) included in the study are: (1) bladder/urinary
tract cancer; (2) breast cancers; (3) colorectal cancer; (4) endometrial
cancer; (5) gastric/esophageal cancer; (6) ovarian cancer; (7) all other
solid tumors with a HER2 mutation; (8) EGFR mutated and/or amplified
primary brain cancer; and (9) solid tumors with a HER3 mutation. The
biliary duct 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 HER2 mutant metastatic biliary
duct basket will now enroll a total of 18 patients.
Dr. David Hyman, Acting Director, Developmental Therapeutics at Memorial
Sloan Kettering Cancer Center and principal investigator of the trial,
stated, "We are pleased to be expanding our evaluation of neratinib in
biliary cancers, an orphan and deadly disease with few treatment
options. We believe this once again demonstrates the value of the basket
study approach, in particular for developing targeted therapy for rare
diseases.”
“We are pleased to expand the third cohort in the basket trial,” said
Alan H. Auerbach, Chief Executive Officer and President of Puma.
“Although it is early, we are pleased with the initial activity that we
are seeing in the patients with HER2 mutated biliary duct cancer in the
trial. 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 during 2016.”
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on
the acquisition, development and commercialization of innovative
products to enhance cancer care. The Company aims to acquire proprietary
rights to these products, by license or otherwise, fund their research
and development and bring the products to market. 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 various 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 Company's Annual Report on Form 10-K for the year ended December
31, 2014 and in subsequent periodic and current reports filed by the
Company with the Securities and Exchange Commission from time to time.
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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