US Oncology Research Collaborates with BioMarin Pharmaceutical to Launch PARP Inhibitor Phase III Study in BRCA Metastatic

  US Oncology Research Collaborates with BioMarin Pharmaceutical to Launch
  PARP Inhibitor Phase III Study in BRCA Metastatic Breast Cancer Patients

  Study may provide further insight on treatment options for BRCA1 and BRCA2
           positive breast cancer patients with metastatic disease

Business Wire

THE WOODLANDS, Texas -- October 24, 2013

US Oncology Research, one of the nation’s largest research networks
specializing in Phase I through IV oncology clinical trials, announced today
it is collaborating with BioMarin Pharmaceutical Inc. to offer a
groundbreaking Phase III study to investigate the use of BMN 673, a PARP
inhibitor, in metastatic breast cancer patients who test positive for BRCA1 or
BRCA2 gene mutations. The study will investigate the effectiveness and safety
of BMN 673, adding to the promising data currently being analyzed from ongoing
Phase I and II studies of the drug. Thirteen US Oncology Research affiliated
practices with 56 locations will participate in the study.

“We are excited to collaborate with BioMarin on this important study that can
lend more insight into the potential of PARP inhibitor BMN 673 in a metastatic
breast cancer setting,” said Joanne L. Blum, M.D., medical oncologist and
director, Hereditary Cancer Risk Program, Texas Oncology-Baylor Charles A.
Sammons Cancer Center and a principle investigator for the study. “This is an
opportunity for patients who have a BRCA1 or BRCA2 gene mutation with
metastatic breast cancer to receive an investigational PARP inhibitor to see
if it will help control the metastatic disease compared to standard
chemotherapy. Eligible patients have the possibility of receiving a promising
novel therapy not available elsewhere while participating in a world-class
study that may change patients’ lives in the future,” she noted.

According to the National Cancer institute (NCI), the strongest known
predictive risk factor for breast cancer is a positive family history for the
disease. Hereditary breast cancer, which can occur generation after generation
in some “cancer families,” can often be explained by specific mutations in the
BRCA1 or BRCA2 genes that belong to a gene class known as tumor suppressors.
Women who have a mutation in one of these genes have a greatly increased risk
of developing breast and/or ovarian cancer during their lifetimes, and men
with these mutations also face an increased risk of breast cancer.

During the past decade, great strides have been made in understanding genetics
and its link to various cancers. Several years ago researchers concluded poly
ADP-ribose polymerases (PARPs) play a critical role in certain pathways that
repair DNA damage, and several recent studies have been investigating
inhibiting the activity of PARPs in tumor cells as a therapeutic approach to
cancer, including PARP inhibition in BRCA-mutated breast cancer.

“We are thrilled to collaborate with US Oncology Research and leverage their
vast network and clinical expertise in the execution of BioMarin’s Phase III
trial in patients with metastatic breast cancer with gBRCA mutations,” said
Hank Fuchs, M.D., chief medical officer of BioMarin. “We look forward to
conducting a world-class study in collaboration with some of the finest
clinical investigators to evaluate the safety and efficacy of BMN 673 in this
setting.”

A Phase III, open-label, randomized, parallel, 2-arm, multi-center study of
BMN 673 versus physician’s choice in germline BRCA mutation subjects with
locally advanced and/or metastatic breast cancer, who have received no more
than 2 prior chemotherapy regimens for metastatic disease will investigate the
drug’s effectiveness, evaluate its safety, and compare it to commonly used
treatments. The trial is currently screening patients for enrollment.

“Thanks to the exemplary performance of our Research Regulatory Team led on
this project by Regulatory Affairs Specialist Jessica Stabler, we were able to
get this study up and running in just eight weeks,” explained Lauren Steckel,
B.S., project manager of Research Operations for US Oncology Research who was
in charge of this project. “With a staff that is deeply committed to our
mission and our large affiliated network of research sites already equipped to
handle complex trials, we can open studies at a rapid pace, especially for
rare patient populations like this one. It is very rewarding to play a role in
bringing these potentially life changing agents to this very special group of
patients as soon as possible,” she noted.

“We are committed to collaborating with others in the cancer community to help
develop promising new treatments for patients battling these rare genetic
cancers,” said Stephen Jones, M.D., medical director for US Oncology Research
and associate chair of its Breast Committee. “With our large network of
affiliated community-based cancer centers, we are uniquely positioned to
rapidly identify and enroll eligible participants in these vital studies that
may eventually improve outcomes and quality of life for these rare patient
populations that are battling these difficult diseases,” he concluded.

About US Oncology Research

Supported by McKesson Specialty Health and The US Oncology Network, US
Oncology Research draws from a network of experienced investigators and
dedicated clinical staff who specialize in Phase I through Phase IV oncology
clinical trials. US Oncology Research serves approximately 80 research sites
and nearly 225 locations managing about 225 active trials at any given time.
Physicians in the research network have enrolled more than 56,000 patients in
nearly 1,300 trials since inception in 1992 and have contributed to the
development of 46 cancer therapies approved by the FDA. For more information
call (800) 482-6700 or visit www.usoncology.com/oncologists.

Contact:

US Oncology Research
Claire Crye, 281-863-6783
claire.crye@usoncology.com
 
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