BioClinica Technology Supports Pharmacyclics in Achieving Early Approval of
IMBRUVICA™ and Breakthrough Therapy Designations for Mantle Cell Lymphoma
(MCL) and Chronic Lymphocytic Leukemia (CLL)
NEWTOWN, Pa., March 11, 2014
NEWTOWN, Pa., March 11, 2014 /PRNewswire/ --BioClinica®, Inc., a leading
provider of specialized outsourced clinical trial services, today announced
that its technology was utilized by Pharmacyclics, Inc. (NASDAQ: PCYC) and
supported the accelerated approval of IMBRUVICA™ (ibrutinib) for Mantle Cell
Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL).
The Phase III clinical program supporting IMBRUVICA's early approval contained
data that was collected and managed with BioClinica's web-based solution and
provided the Pharmacyclics team instant online access to review and analyze
clinical data as it was captured in this global study, which involved 391
patients and was conducted at clinical sites in 10 countries. "Our partnership
with BioClinica was important in ensuring collection of data from our clinical
studies. We have utilized BioClinica's technology now for four years and
greatly appreciate the level of service and support we have received,"
remarked Maria Fardis, PhD, Chief of Oncology Operations and Alliances at
BioClinica's technology enabled Pharmacyclics as well to maximize efficiencies
in multiple study aspects with a high level view of operational data including
study metrics and site status. A centralized clinical trial portal aggregated
data from multiple data sources for real-time visibility. BioClinica's
technology was also used for patient randomization and support in clinical
"This was a true partnership that extends beyond software products," said
BioClinica's Director of Data Operations Kathleen Yeager, CCDM. "We strive to
give our customer all of the tools, training and resources needed for a
well-run study and we stand by them every step of the way on through to
regulatory submission." Yeager added, "It is very satisfying to be part of
the drug development process, helping to bring new therapies and hope to
people in need." Yeager explained further, "We knew the importance of the
compound to Pharmacyclics so we provided solutions to decrease time and
labor-intensive manual processes with automation everywhere possible."
BioClinica has supported Pharmacyclics research with eClinical technologies
for multiple studies in Phases I, II, and III since 2010.
IMBRUVICA is indicated for the treatment of patients with mantle cell lymphoma
or chronic lymphocytic leukemia who have received at least one prior
therapy.For more information about IMBRUVICA, including the full prescribing
information, please visitwww.IMBRUVICA.com. IMBRUVICA is a first in class,
oral therapy and is a new agent that inhibits a protein called Bruton's
tyrosine kinase (BTK).BTK is a key signaling molecule of the B-cell receptor
signaling complex that plays an important role in the survival and spread of
malignant B-cells.IMBRUVICA blocks signals that tell malignant B-cells to
multiply and spread uncontrollably.It is one of the first medicines to file
forFDAapproval via the new Breakthrough Therapy Designation pathway,
enabling Pharmacyclicsto rapidly bring this medicine to patients in need.
To date,ten Phase III trials have been initiated with ibrutinib and a total
of41 trials are currently registered onwww.clinicaltrials.gov. Janssen and
Pharmacyclicsentered a collaboration and license agreement inDecember
2011to co-develop and co-commercialize IMBRUVICA.
About BioClinica, Inc.
BioClinica, Inc. is a leading global provider of integrated clinical trial
management technologies including eClinical solutions for electronic data
capture (EDC), randomization (IRT), clinical trial management (CTMS), and
clinical trial supply management, forecasting and optimization (CTSM).
BioClinica's Imaging and Cardiovascular division offers unmatched scientific
expertise with its team of respected medical researchers; electronic transfer,
management, and independent review of medical images; plus cardiovascular
safety monitoring including automated ECG, Thorough QT studies, Holter
monitoring, ambulatory blood pressure monitoring and pulse wave analysis. With
more than 29 years of experience and over 3000 successful trials to date,
BioClinica has supported the development of many new medicines through all
phases of the clinical trial process. BioClinica operates state-of-the-art,
regulatory-body-compliant imaging core labs on three continents, and supports
worldwide eClinical, comprehensive cardiovascular safety, and data management
services from offices in the United States, Europe and Asia. For more
information, please visit www.bioclinica.com.
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SOURCE BioClinica, Inc.
Contact: Jim Dorsey, BioClinica, Inc., 267-757-3040, or Trade Media - Jennifer
Wolk, DDCworks, 484-342-3600
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