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 /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 Pharmacyclics.
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 supplies management.
"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 visit www.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 for FDA approval via the new Breakthrough Therapy Designation pathway enabling Pharmacyclics to rapidly bring this medicine to patients in need.
To date ten Phase III trials have been initiated with ibrutinib and a total of 41 trials are currently registered on www.clinicaltrials.gov. Janssen and Pharmacyclics entered a collaboration and license agreement in December 2011 to 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 studiesHolter 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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