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NEWTON, Mass., May 18, 2017 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that interim clinical data from the ongoing Phase 2b SADAL study evaluating lead product candidate, selinexor (KPT-330), an oral Selective Inhibitor of Nuclear Export / SINE™ compound, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be featured in an oral presentation at the 22nd Congress of the European Hematology Association (EHA) taking place June 22-25, 2017 in Madrid, Spain. “DLBCL is the most common type of non-Hodgkin lymphoma among adults and there remains a high unmet medical need, particularly in the relapsed and refractory setting for patients who are not eligible for stem cell transplant or who relapse afterward,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm.  “Previously reported data from the ongoing Phase 2b SADAL study showed that treatment with single-agent oral selinexor resulted in robust response rates with prolonged durability in patients with heavily pretreated DLBCL, including against both GCB and non-GCB (ABC) subtypes.  We look forward to sharing some further detail from the SADAL study with the medical community at EHA and ICML this year.” In addition, Karyopharm’s Phase 2b SADAL data were also selected for a poster presentation at the 14th International Conference on Malignant Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland. Details for the Oral Presentation at EHA 2017: Title: Single Agent Oral Selinexor Exhibits Durable Responses in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) of Both GCB and Non-GCB Subtypes: The Phase 2b SADAL Study Presenter: Marie Maerevoet, Institute Jules Bordet, Brussels, Belgium Abstract code: S469 Topic: Aggressive Non-Hodgkin lymphoma – Clinical Session: Aggressive Non-Hodgkin lymphoma – Relapsed/refractory Location: Hall C Date and Time: Saturday, June 24, 2017 from 14:45 - 17:00 CET Details for the Poster Presentation at ICML 2017: Title: A Phase 2b Randomized Study of Single Agent Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Presenter: Rene-Olivier Casanovas, Hematologie Clinique, CHU Dijon, France Poster #: 193 Location: Marquee Parco Ciani Date and Time: From Wednesday, June 14, 2017 at 12:00 CET through Friday, June 16, 2017 at 18:30 CET Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,000 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in May 2017. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform the Company's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov. Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com. This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. For example, there can be no guarantee that any of Karyopharm's SINE™ compounds, including selinexor (KPT-330), will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2017, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


NEWTON, Mass., May 18, 2017 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that interim clinical data from the ongoing Phase 2b SADAL study evaluating lead product candidate, selinexor (KPT-330), an oral Selective Inhibitor of Nuclear Export / SINE™ compound, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be featured in an oral presentation at the 22nd Congress of the European Hematology Association (EHA) taking place June 22-25, 2017 in Madrid, Spain. “DLBCL is the most common type of non-Hodgkin lymphoma among adults and there remains a high unmet medical need, particularly in the relapsed and refractory setting for patients who are not eligible for stem cell transplant or who relapse afterward,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm.  “Previously reported data from the ongoing Phase 2b SADAL study showed that treatment with single-agent oral selinexor resulted in robust response rates with prolonged durability in patients with heavily pretreated DLBCL, including against both GCB and non-GCB (ABC) subtypes.  We look forward to sharing some further detail from the SADAL study with the medical community at EHA and ICML this year.” In addition, Karyopharm’s Phase 2b SADAL data were also selected for a poster presentation at the 14th International Conference on Malignant Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland. Details for the Oral Presentation at EHA 2017: Title: Single Agent Oral Selinexor Exhibits Durable Responses in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) of Both GCB and Non-GCB Subtypes: The Phase 2b SADAL Study Presenter: Marie Maerevoet, Institute Jules Bordet, Brussels, Belgium Abstract code: S469 Topic: Aggressive Non-Hodgkin lymphoma – Clinical Session: Aggressive Non-Hodgkin lymphoma – Relapsed/refractory Location: Hall C Date and Time: Saturday, June 24, 2017 from 14:45 - 17:00 CET Details for the Poster Presentation at ICML 2017: Title: A Phase 2b Randomized Study of Single Agent Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Presenter: Rene-Olivier Casanovas, Hematologie Clinique, CHU Dijon, France Poster #: 193 Location: Marquee Parco Ciani Date and Time: From Wednesday, June 14, 2017 at 12:00 CET through Friday, June 16, 2017 at 18:30 CET Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,000 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in May 2017. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform the Company's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov. Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com. This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. For example, there can be no guarantee that any of Karyopharm's SINE™ compounds, including selinexor (KPT-330), will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2017, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


NEWTON, Mass., May 18, 2017 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that interim clinical data from the ongoing Phase 2b SADAL study evaluating lead product candidate, selinexor (KPT-330), an oral Selective Inhibitor of Nuclear Export / SINE™ compound, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) will be featured in an oral presentation at the 22nd Congress of the European Hematology Association (EHA) taking place June 22-25, 2017 in Madrid, Spain. “DLBCL is the most common type of non-Hodgkin lymphoma among adults and there remains a high unmet medical need, particularly in the relapsed and refractory setting for patients who are not eligible for stem cell transplant or who relapse afterward,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm.  “Previously reported data from the ongoing Phase 2b SADAL study showed that treatment with single-agent oral selinexor resulted in robust response rates with prolonged durability in patients with heavily pretreated DLBCL, including against both GCB and non-GCB (ABC) subtypes.  We look forward to sharing some further detail from the SADAL study with the medical community at EHA and ICML this year.” In addition, Karyopharm’s Phase 2b SADAL data were also selected for a poster presentation at the 14th International Conference on Malignant Lymphoma (ICML) being held June 14-17, 2017 in Lugano, Switzerland. Details for the Oral Presentation at EHA 2017: Title: Single Agent Oral Selinexor Exhibits Durable Responses in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) of Both GCB and Non-GCB Subtypes: The Phase 2b SADAL Study Presenter: Marie Maerevoet, Institute Jules Bordet, Brussels, Belgium Abstract code: S469 Topic: Aggressive Non-Hodgkin lymphoma – Clinical Session: Aggressive Non-Hodgkin lymphoma – Relapsed/refractory Location: Hall C Date and Time: Saturday, June 24, 2017 from 14:45 - 17:00 CET Details for the Poster Presentation at ICML 2017: Title: A Phase 2b Randomized Study of Single Agent Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Presenter: Rene-Olivier Casanovas, Hematologie Clinique, CHU Dijon, France Poster #: 193 Location: Marquee Parco Ciani Date and Time: From Wednesday, June 14, 2017 at 12:00 CET through Friday, June 16, 2017 at 18:30 CET Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,000 patients have been treated with selinexor and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in combination with low-dose dexamethasone (STORM) and backbone therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Karyopharm plans to initiate a pivotal randomized Phase 3 study of selinexor in combination with bortezomib (Velcade®) and low-dose dexamethasone (BOSTON) in patients with multiple myeloma in May 2017. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform the Company's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov. Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other major diseases. Karyopharm's SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). In addition to single-agent and combination activity against a variety of human cancers, SINE™ compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm, which was founded by Dr. Sharon Shacham, currently has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com. This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm's drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company's current expectations. For example, there can be no guarantee that any of Karyopharm's SINE™ compounds, including selinexor (KPT-330), will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm's drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm's drug candidate portfolio will result in stock price appreciation. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm's results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, including with respect to the need for additional clinical studies; Karyopharm's ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm's competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm's ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption "Risk Factors" in Karyopharm's Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on May 4, 2017, and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and, except as required by law, Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.


Grant
Agency: European Commission | Branch: FP7 | Program: NoE | Phase: HEALTH.2010.2.4.1-2 | Award Amount: 15.56M | Year: 2011

Europe has a number of advantages as regards developing translational cancer research, yet there is no clear European strategy to meet the increasing burden posed by cancer. The FP6 Eurocan\Plus project analysed the barriers underlying the increasing fragmentation of cancer research and stressed the need to improve collaboration between basic/preclinical and comprehensive cancer centres (CCCs), institutions in which care and prevention is integrated with research and education. Furthermore, it proposed the creation of a platform of interlinked cancer centres with shared infrastructures and collaborative projects to facilitate rapid advances in knowledge, and their translation into better cancer care. In response to these challenges and in line with the call, EurocanPlatform will work towards the goal of decreasing cancer mortality by dealing with three main areas of strategic research: prevention, early detection and improved treatments. It will build the necessary resources and know-how for the entire research continuum: basic research, early and late translational research, clinical research, epidemiological research, implementation in care and population based outcome research. There will be a strong focus on discovery-driven translational cancer research in five selected tumours: breast, head-neck, lung, malignant melanoma and pancreatic cancer. Joint structures and programmes for early detection will contribute to optimal treatment, and novel prevention research programmes will integrate prevention activities in clinical cancer centres as well as public prevention. Collaborations will also include molecular pathway-driven clinical research supported by joint structures for omics, biobanking and biomarker validation to support clinical trials aimed at enhancing patient benefits by individualised treatments. EurocanPlatform is unique in its nature and represents a commitment from cancer centres to join forces and resources in order to fight cancer.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: HEALTH-2009-2.1.1-2 | Award Amount: 13.88M | Year: 2010

All cancers arise due to somatically acquired mutations in their genomes which alter the function of key cancer genes. Understanding these critical mutational events underlying cancer development is paramount for advancing prevention, early detection, monitoring and treatment of the disease. Breast cancer is the most common class of cancer diagnosed in women worldwide with more than one million cases diagnosed annually. It is responsible for >400,000 deaths per year making it the leading cause of cancer deaths in women and is the most common cause of all deaths in women aged >40yrs. Breast cancer is a heterogeneous disease with a number of subtypes. We propose here to generate complete catalogues of somatic mutations in 500 breast cancers, of the ER\ve HER2- subclass, under the International Cancer Genome Consortium model by high coverage, shotgun genome sequencing of both tumour and normal DNA. All classes of mutations are expected to be detected including base substitutions, insertions, deletions, copy number changes and rearrangements. These catalogues of mutations will afford us statistical power to identify cancer genes that are mutated at a frequency of greater than 3% in this class of breast cancer. Complementary catalogues of epigenomic changes (genome-wide DNA methylation) will be generated for the same cancer samples together with transcript expression profiles. Integrated analyses of these data will be carried out and compared to parallel datasets from other classes of breast cancer and other types of cancer. The potential clinical utility of these findings for detection and monitoring of minimal residual disease will be investigated. Finally, data will be made rapidly available to all scientific researchers with minimal restrictions. The results of this exhaustive and comprehensive set of studies will have an enormous impact on our understanding of the causes and biology of breast cancer and will lead to major advances in detection, prevention and treatment of breast cancer


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.1.2-1 | Award Amount: 7.24M | Year: 2012

While early detection of breast cancer by screening appears effective, many women derive little or no benefit from screening, due to the way it is currently organized: as a one-size-fits all approach irrespective of personalised risk factors. It is known, however, that some women are at a much higher risk of getting the disease than others, and that mammography is unsuitable for cancer detection in women with dense breasts. The aim of this project is to develop personalised methods to tailor breast cancer screening to the individual needs of the woman. We will propose methods to stratify women at the highest risk to MRI; those with intermediate risk and/or dense breasts to follow-on ultrasound. A risk model will be developed that includes both breast cancer risk and the risk of missing cancers in mammograms. In this model, breast density plays a key role, as one of the largest known risk factors and the factor making mammograms ineffective. Two SMEs focusing on breast density are involved, where academic partners bring unique databases with over 80,000 screening mammograms and associated risk profiles. These are essential for model development, and subsequently for the development of products that benefit all women. Personalised screening is only economically feasible if it is based upon cost-effective strategies. While current methods in breast MRI imaging and breast ultrasound are promising, more efficient protocols must be developed to use these modalities routinely in screening. With leading SMEs and clinical partners, screening procedures will be optimized by developing automated image analysis tools to guide workflow and quality assurance. More efficient MRI protocols will be investigated to reduce time and cost, while the use of novel MRI imaging sequences without intravenous contrast will be explored. Cost-effectiveness of the stratification models will be assessed by combining the risk model with cost and effectiveness of alternative screening strategies.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2011.1.1-2 | Award Amount: 7.78M | Year: 2012

Individualisation of cancer therapy based on standardized biomarker assays is one of the most demanding challenges in cancer medicine. In the RESPONSIFY consortium, we will integrate information on response prediction from different breast cancer types and methodologies into biomarker tests for targeted therapies in the clinical routine setting. Those tests will be developed for commercialisation using the expertise of the involved SMEs and industrial partners. To reach this aim, we will use different genome based strategies to identify and characterise new biomarkers as well as validate biomarkers from previous projects. Genome based strategies include new molecular techniques such as genome wide next generation sequencing, epigenetics, gene and exon expression analysis, as well as kinome arrays, in-situ proteomics and quantitative PCR using FFPE tissue. A clearly defined marker finding-training-validation-approach will be the backbone of RESPONSIFY to reach a high level of evidence for commercial diagnostic tests. The established therapy stratification criteria will be further validated within clinical trials using the expertise of the clinical study groups. The clinical study group will develop a web-based data integration and processing system to standardise integration of clinical trial data and biomarker results in one system which will be further used for clinical biomarker driven trials. Health economic characteristics of combined testing and treatment strategies will be determined to inform decision makers, using state-of-the-art cost-utility analysis. Optimising the use of current therapy options and avoiding treatments patients will predictably not respond to, may improve cost-utility parameters to levels acceptable for most health systems. For rapid evaluation of response parameters, the major focus will be on neoadjuvant therapy. The RESPONSIFY project will lead to validated tests based on formalin-fixed paraffin embedded tissue to predict resistance


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ICT-2011.5.3 | Award Amount: 13.40M | Year: 2012

EURECA aims to build an advanced, standards-based and scalable semantic integration environment enabling seamless, secure and consistent bi-directional linking of clinical research and clinical care systems to: 1.Support more effective and efficient execution of clinical research by Allowing faster eligible patient identification and enrolment in clinical trials, Providing access to the large amounts of patient data, Enabling long term follow up of patients, Avoid the current need for multiple data entry in the various clinical care. 2.)Allow data mining of longitudinal EHR data for early detection of patient safety issues related to therapies and drugs that would not become manifest in a clinical trial either due to limited sample size or to limited trial duration, 3:)Allow for faster transfer of new research findings and guidelines to the clinical setting (from bench-to-bedside), 4.) Enable healthcare professionals to extract in each patients case the relevant data out of the overwhelmingly large amounts of heterogeneous patient data and treatment information. At the core of the project will be achieving semantic interoperability among EHR and clinical trial systems, consistent with existing standards, while managing the various sources of heterogeneity: technology, medical vocabulary, language, etc. This requires the definition of sound information models describing the EHR and the clinical trial systems, and capturing the semantics of the clinical terms by standard terminology systems. The scalability of the solution will be achieved by modularization, identifying core data subsets covering the chosen clinical domains. We demonstrate and validate concepts developed in EURECA by implementing a set of software services and tools that we deploy in the context of pilot demonstrators. EURECA will develop solutions that fulfill the data protection and security needs and the legal, ethical and regulatory requirements related to linking research and EHR data.


Grant
Agency: European Commission | Branch: FP7 | Program: CP | Phase: ICT-2009.5.3 | Award Amount: 5.68M | Year: 2011

There is a strong need in biomedical research, especially in the case of complex heterogeneous diseases such as cancer, to achieve an all-comprising harmonization of efforts: To integrate the available data and knowledge in comprehensive models supported by interoperable infrastructures and tools, to standardize methodologies, and to achieve wide-scale data sharing and reuse, and multidisciplinary collaboration. INTEGRATE aims to build solutions that support a large and multidisciplinary biomedical community ranging from basic, translational and clinical researchers to the pharmaceutical industry to collaborate, share data and knowledge, and build and share predictive models for response to therapies, with the end goal of improving patient outcome. Moving away from empirical medicine, towards evidence-based personalized care has the potential to both dramatically improve patient outcome and to reduce costs. INTEGRATE will deliver reconfigurable infrastructure components; tools for sharing and collaboration; standards-based data models; and repositories of data, models and knowledge. The INTEGRATE environment will enable: Collection, preservation, management and reuse of data collected within multi-centric clinical trials. These unique comprehensive datasets will be made available through uniform interfaces to support information sharing and collaborative knowledge generation. Multi-disciplinary collaboration, providing an environment and tools that support researchers across domains, institutions and industries to jointly contribute to research objectives, develop common methodologies and complex analyses, and efficiently make use of each others expertise and results. Collaborative definition and development of relevant clinical questions and more efficient validation of potential biomarker results and predictive models in clinical trials. Collaborative development, preservation and sharing of multi-scale realistic and validated predictive models of response to novel therapies and anti-cancer drugs. We will propose methodologies for model development, a modelling framework, and predictive multi-scale models in the context of breast cancer. INTEGRATE will also provide standards-based interoperability to existing research and clinical infrastructures to support efficient information reuse and integration.

Loading Institute Jules Bordet collaborators
Loading Institute Jules Bordet collaborators