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Crescendo Bioscience to Present New Data on Vectra DA Use to Assess Radiographic Progression Risk in Patients with Rheumatoid Arthritis Treated with Traditional and Biologic Therapies at the European League Against Rheumatism Annual Meeting (EULAR)

Crescendo Bioscience, a molecular diagnostics company dedicated to developing and commercializing quantitative blood tests for rheumatoid arthritis (RA) and other auto-immune diseases, announced today that it will present data from ten different studies that further support the important role Vectra® DA can play in managing Rheumatoid Arthritis (RA) at the European League Against Rheumatism (EULAR) Annual Meeting held in Madrid, Spain, on June 12-15. EULAR is the largest gathering of rheumatology healthcare professionals in Europe. Vectra DA is an objective, validated blood test that provides rheumatologists with a score of 1-100, giving biological insight into the level of disease activity of rheumatoid arthritis. Data presented at EULAR will demonstrate Vectra DA’s ability to assess risk of radiographic progression (joint damage over time) in patients with RA currently treated with traditional and biologic agents, including TNF inhibitors. In addition, data will show how Vectra DA can detect a high level of RA disease activity in patients with a low C-reactive protein (CRP) without being affected by fibromyalgia, a painful non-inflammatory condition that can co-exist with RA.

This week, researchers will present data from a study conducted by the University of Occupational and Environmental Health in Kitakyushu, Japan, A Multi-biomarker Disease Activity (Vectra DA Algorithm) Score is Associated with Radiographic Outcomes in RA Patients Treated with TNF inhibitors (#SAT0012) . This study found that patients who were being treated with adalimumab, etanercept or infliximab and had a low Vectra DA score (29 or less) in at least two of three visits over one year showed little or no radiographic progression. In contrast, patients with high scores (greater than 44) for at least two of three visits had a much higher risk of clinically relevant radiographic progression. In addition, researchers found that change in the Vectra DA score over the first six months of treatment correlated with radiographic outcomes in the first year. This is the first time risk of radiographic progression in patients treated with TNF inhibitors was assessed using Vectra DA over time.

“We know that anti-TNF drugs have been shown to help minimize the overall amount of radiographic progression,” said Yoshiya Tanaka, MD, PhD, Professor and Chairman, University of Occupational and Environmental Health, Kitakyushu, Japan. “This study underscores the clinical utility of Vectra DA to objectively assess which patients remain at risk of radiographic progression despite anti-TNF therapy. This information could be important in helping rheumatologists confirm or potentially revise their treatment plan.”

“This study demonstrates the additional value Vectra DA can bring to the overall RA patient management experience,” said Oscar Segurado, MD, PhD, Chief Medical Officer at Crescendo Bioscience. “With a number of RA drugs available today, and more than 50 agents in development, a quantifiable disease activity measurement test like Vectra DA can be a true asset for physicians.”

Researchers will also present new data regarding use of Vectra DA in patients with both RA and fibromyalgia. In Application of a Multi-Biomarker Disease Activity (Vectra DA) Score for Assessing Rheumatoid Arthritis Patients with Low CRP or Fibromyalgia (#SAT0099), researchers from the Brigham and Women’s Hospital and Harvard Medical School showed that in patients with RA, traditional methods of disease assessment, including tender joint count, DAS28-CRP, and Patient Global Assessment were markedly increased by the presence of fibromyalgia, a painful non-inflammatory syndrome that can confound the assessment of patients with RA. In contrast, the Vectra DA test measured essentially the same level of disease activity in patients with RA independent of the presence of fibromyalgia, which highlights the value of the objective nature of the test.

“Vectra DA provides additional information about disease activity that is not provided by other assessment tools such as C-reactive protein (CRP),” said Segurado. “This study showed that in patients with low CRP, nearly half had Vectra DA scores in the moderate to high disease activity range, indicating that their RA was actually more active than originally found with CRP. This information will help physicians attain better insight to the underlying biology of the disease.”

Additional Poster Highlights

A study selected by EULAR will be part of the Poster Tour (FRI0098) Friday, June 14 between 11:45 am and 1:30 pm, Biomarker-Based Estimates of Risk of Radiographic Progression in the Leiden Early Arthritis Cohort, and researchers from the Leiden University Medical Center, Leiden, the Netherlands will discuss the use of Vectra DA as a tool to estimate the risk of radiographic progression in RA.

“Using the Vectra DA score, we were able to see a correlation between the score and risk of radiographic progression over 12 months,” said Tom W.J. Huizinga, M.D., Head of the Department of Rheumatology, Leiden University Medical Center, Leiden, the Netherlands and primary investigator. “This tells us that Vectra DA can be helpful in identifying patients at high risk for radiographic progression and, thus, give rheumatologists more information to help prevent future progression.”

Another poster, A Multi-Biomarker Disease Activity Blood Test (Vectra DA) Correlates with Radiographic Progression in Early Rheumatoid Arthritis: Results from the SWEFOT Trial (#FRI0060), focused on use of Vectra DA in assessing risk of radiographic progression in early RA. The SWEFOT study is the Swedish Pharmacotherapy Trial out of the Karolinska Institutet in Stockholm.

In early RA patients starting methotrexate, the study found that Vectra DA’s score, when assessed at baseline, significantly correlated with radiographic progression in the first year. “A high MBDA score at baseline was associated with a higher risk of radiographic progression, even in patients who had moderate disease activity by DAS28 or low CRP at baseline,” said Ronald F. van Vollenhoven,M.D., Ph.D., Professor and Chief, Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID), Chief, Clinical Trials Unit, Department of Rheumatology, the Karolinska Institute and primary investigator of the study.

Other Vectra DA Posters Presented at 2013 EULAR Annual meeting

Additional study results (presented in six posters listed below) further demonstrate and confirm the ability of Vectra DA to objectively assess disease activity and/or potentially identify risk for radiographic progression in early- and later-stage RA patients.

Poster #FRI0061

Multi-Biomarker Disease Activity (MBDA) Score and the 12 Individual Biomarkers in Early Rheumatoid Arthritis Patients Relate Differently to Clinical Response and Radiographic Progression: Results from SWEFOT Trial; K. Hambardzumyan, Karolinska Institutet, ClinTRID, Stockholm, Sweden, and other collaborators.

Poster #FRI0062

Evaluation of a Multi-Biomarker Disease Activity (Vectra DA Algorithm) in Early Rheumatoid Arthritis and Unclassified Arthritis Patients; K. I. Maijer, Department of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, the Netherlands and other collaborators.

Poster #FRI0066

Behavior of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components in Patients with Rheumatoid Arthritis Treated with Tocilizumab; K. Hanami, The First Department Of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, and other collaborators.

Poster # FRI0075

A Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score and Components are Associated with Sustained Clinical Remission in Rheumatoid Arthritis: the REMIRA Study; M. H. Ma, Academic Department of Rheumatology, King’s College London, London, United Kingdom and other collaborators.

Poster #FRI0079

Response to MTX Plus Prednisone in CAMERA II Using a Multi-Biomarker Disease Activity Test (Vectra DA) and DAS28-ESR; M. S. Jurgens, Rheumatology & Clinical Immunology, UMC UTRECHT, Utrecht, Netherlands and other collaborators.

Poster #SAT0033

Characterization of the Multi-Biomarker Disease Activity (Vectra DA Algorithm) Score in a Subgroup of Patients from the Epidemiological Investigation of Rheumatoid Arthritis (EIRA) Cohort Receiving Methotrexate; W. Li, Crescendo Bioscience, Inc., South San Francisco and other collaborators.

Source: GlobeNewswire

West Clinic Researchers Present Findings at 2013 American Society for Clinical Oncology (ASCO) Meeting

The West Clinic, the Mid-South’s premier cancer center and world-class center of excellence in medical oncology, hematology, oncologic imaging, clinical research and other advanced medical care, recently announced five of its physician-researchers will participate in ten presentations at the 49th Annual American Society of Clinical Oncology (ASCO) Meeting to be held May 31-June 4, 2013 in Chicago, IL at the McCormick Palace. Over 30,000 members of the oncology community from across the nation and around the world are expected to attend the five-day international scientific and educational oncology conference. This year’s theme is “Building Bridges to Conquer Cancer.”

The West Clinic’s findings, which focus on leading-edge treatments for non-small cell lung cancer, colorectal cancer, lymphoma, and breast cancer, were selected by a highly competitive peer-review process.

“The West Clinic continues to further its research mission with a strong showing at ASCO, the world’s premier oncology meeting,” according to Lee S. Schwartzberg, MD, FACP, Medical and Research Director, The West Clinic; President, ACORN Research, LLC; and Chief, Division of Hematology/Oncology and Professor of Medicine, University of Tennessee Health Science Center. “Over 5000 abstracts from around the world were submitted this year. Our invitation to present four out of five West Clinic/ACORN abstracts reflects our reputation for being a major oncology research center. We are also pleased that our Chief Fellow, Dr. Jessica Snider, is first author on an important neo-adjuvant breast cancer trial that she will present.”

Landmark research has been a heritage of The West Clinic and its continued commitment to a robust program is strong with participation in approximately 40 open studies, 12 of which are Phase I. West Clinic physicians conduct a broad spectrum of clinical research trials ranging from Phase I to Phase IV studies in collaboration with major pharmaceutical companies, the National Cancer Institute, cooperative groups, and its own investigator initiated trials funded by grants. West Clinic has one of the most advanced research programs of its kind in the country and played a major role in the development of new drugs for breast cancer, colon cancer, lung cancer, prostate cancer, lymphoma, and many other diseases.

“This year’s theme Building Bridges to Conquer Cancer parallels our vision and unique collaboration with the University of Tennessee Health Science Center, Methodist Healthcare, and researchers across the country through ACORN Research, further positioning West Clinic as an innovative leader, exploring new cancer-fighting treatments, and saving more lives,” stated Dr. Schwartzberg.

The following West Clinic physicians contributed to ASCO presentations.

GENERAL POSTER PRESENTATIONS

  1. Dr. Lee Schwartzberg: Serum and tumor biomarkers to predict outcome in the eLung trial, a multicenter, randomized phase IIb study of standard platinum doublets (PD) plus cetuximab (CET) as first-line treatment of advanced non-small cell lung cancer (NSCLC). http://abstracts2.asco.org/AbstView_132_110479.html
  2. Dr. Lee Schwartzberg; Dr. Obiageli Ogbata: Real-world symptom burden and early treatment discontinuation in first-line metastatic breast cancer (MBC). http://abstracts2.asco.org/AbstView_132_110594.html
  3. Dr. Lee Schwartzberg: From Bayesian modeling to genomic mapping: Biologic validity of predictive single nucleotide polymorphism networks for chemotherapy-related side effects. http://abstracts2.asco.org/AbstView_132_114956.html
  4. Dr. Lee Schwartzberg: Phase I/II study of neoadjuvant carboplatin, eribulin mesylate, and trastuzumab (ECH) for operable HER2 positive (HER2+) breast cancer. http://abstracts2.asco.org/AbstView_132_110308.html
  5. Dr. Lee Schwartzberg: Analysis of KRAS/NRAS mutations in PEAK: A randomized phase II study of FOLFOX6 plus panitumumab (pmab) or bevacizumab (bev) as first-line treatment (tx) for wild-type (WT) KRAS (exon 2) metastatic colorectal cancer (mCRC). http://abstracts2.asco.org/AbstView_132_116726.html
  6. Dr. Lee Schwartzberg: Initial results from the 21-gene breast cancer assay registry: A prospective observational study in patients (pts) with ER+, early-stage invasive breast cancer (EBC). http://abstracts2.asco.org/AbstView_132_113096.html
  7. Dr. Lee Schwartzberg: Phase II study of lapatinib in combination with vinorelbine, as first- or second-line therapy in women with HER2-overexpressing metastatic breast cancer. http://abstracts2.asco.org/AbstView_132_115057.html
  8. Dr. Jessica Snider: Pathologic complete response (pCR) with weekly nanoparticle albumin bound (nab-P) plus carboplatin (C) followed by doxorubicin plus cyclophosphamide (AC) with concurrent bevacizumab (B) for triple-negative breast cancer (TNBC). http://abstracts2.asco.org/AbstView_132_117576.html
  9. Dr. Brad Somer: Randomized phase II study with window-design to evaluate anti-tumor activity of the survivin antisense oligonucleotide (ASO) ly2181308 in combination with docetaxel for first-line treatment of castrate-resistant prostate cancer (CRPC). http://abstracts2.asco.org/AbstView_132_108714.html
  10. Dr. Daruka Mahadevan: Genetic and cytokine profiles associated with symptomatic stage of CLL. http://abstracts2.asco.org/AbstView_132_113916.html

PUBLICATIONS ONLY

  1. Dr. Lee Schwartzberg: A phase IIb trial of coix seed injection for advanced pancreatic cancer. http://abstracts2.asco.org/AbstView_132_115489.html
  2. Dr. Daruka Mahadevan: Phase Ib study of safety, tolerability, and efficacy of R1507 a monoclonal antibody to IGF-1R in combination with multiple standard chemotherapy regimens in patients with advanced solid malignancies. http://abstracts2.asco.org/AbstView_132_110601.html

Source: PR Newswire

Zimmer Launches a New Era in Knee Replacement with Persona™ The Personalized Knee System

Zimmer Holdings, Inc. (NYSE and SIX: ZMH), a global leader in musculoskeletal health, recently introduced Persona The Personalized Knee System, at the 2013 American Academy of Orthopaedic Surgeons Annual Meeting. The Persona System ushers in a new era in total knee replacement, combining personalized implants with intelligent instrumentation to provide surgeons with a new level of intraoperative precision to customize the best fit for their patients.

More than 600,000 total knee replacements are performed each year in the United States. While total knee replacement is among the most clinically successful procedures in modern medicine, patient expectations are increasing, leaving some patients less than fully satisfied. Despite the success of total knee replacement, current knee systems lack the fidelity to precisely match the anatomy and biomechanics of the natural knee for a global patient population.

As the market leader and a pioneer in total knee replacement, Zimmer committed to engineer the highest fidelity knee system ever. Building upon the clinical legacy of Zimmer’s NexGen® and Natural-Knee® systems, two of the world’s most clinically-proven and widely used knee systems, Zimmer employed cutting-edge scientific tools to design Persona The Personalized Knee System, which aims to deliver unprecedented fit, natural feel, and normal function.

“The Persona System is the most comprehensive, anatomically accurate and highest fidelity knee replacement system ever designed,” said Jeff McCaulley, President, Zimmer Global Reconstructive. “Zimmer scientists and engineers and their designing surgeon partners pushed the boundaries of implant design, drawing upon advanced morphology, physiology, kinesiology and material sciences to develop a truly revolutionary system that allows surgeons to provide each patient with a personalized fit.”

A number of breakthrough technologies went into the design of Persona The Personalized Knee System:

  • Zimmer’s Bone Resection Atlas (ZiBRA) is an advanced bone atlas with virtual resection and component placement capabilities. This tool allowed the Persona System’s surgeon designers and engineers to study the morphology of hundreds of bones, representing a diverse global population, to precisely define anatomically accurate implant shapes and sizes.
  • Zimmer’s Virtual Biomechanical Knee (VBK) is a kinematic computational analysis program that allows rapid testing of hundreds of different design options to virtually assess their impact on soft tissues, motion and overall performance to optimize designs that more closely replicate natural feel and normal function.
  • Zimmer’s Robotic Simulator uses a six-axis, high-precision robot to replicate the kinematic patterns and biomechanical forces for a range of patient daily activities, validating the fidelity, precision and robustness of the implant designs.

Building upon this revolutionary design, the Persona System incorporates Zimmer’s most advanced material technologies. Vivacit-E® advanced bearing surface material, incorporating Vitamin E, offers improved strength, ultra-low wear and exceptional oxidative stability for long-term performance. Trabecular Metal TM Technology porous metal is available on every compartment of the new knee system, facilitating biologic fixation of the knee replacement.

Complementing the most personalized and precise knee implant system, Zimmer is introducing a range of intelligent instrumentation to perform more precise and efficient procedures.

“The instrumentation for the Persona System was specifically designed to provide surgeons with a new level of precision in order to take full advantage of the fidelity of the Persona implants,” said Steve White, General Manager and Vice President, Knees at Zimmer. “Surgeons told us that to create a more natural feeling, normal functioning knee for patients, we needed to develop implants and instruments that enable a more precise intraoperative fit and feel.”

Zimmer’s intelligent instrument technologies for Persona The Personalized Knee System include: Zimmer® Patient Specific Instruments, which utilize pre-operative MRI images of a patient’s knee to create customized surgical instruments in order to improve implant placement; iASSIST TM Knee, The Personalized Guidance System TM, a revolutionary surgical guidance technology that provides simple, intuitive and accurate intraoperative feedback and alignment verification at the surgical site without the need for bulky capital equipment; and the eLibra® Dynamic Knee Balancing System, which enables precise rotation of the femoral components to facilitate efficient and reliable soft tissue balancing.

Persona The Personalized Knee System represents a significant advance in personalization and precision for surgeons and their patients. The system also represents a breakthrough for healthcare systems, providing a premium implant, while reducing total costs and increasing efficiencies in and around the procedure. Leveraging the latest advances in surgery scheduling, pre-operative planning, digital templating, and contemporary logistics, the Persona System’s innovative modular trays allow surgeons to select only the instruments and sizes needed to successfully complete the surgery, minimizing the total number of trays for each case. When used in conjunction with intelligent instruments, Persona Knee procedures can be executed with only two to three trays.

“We designed the Persona System to meet the demands of today’s patients and provide unmatched surgical precision for surgeons, all in the context of concerns about the total cost of care. The Persona System was designed to help hospitals deliver high quality, consistent outcomes while reducing total costs,” said Jeff McCaulley. “Zimmer has long been the global leader in knee replacement technology, but with the Persona System and our new intelligent instrument offerings, we are revolutionizing the standard of care for patients for the next decade and beyond.”

Source: PR Newswire

Caris Life Sciences Adds Next-Generation Sequencing to Enhance Evidence-Based Tumor Profiling Service for Cancer Patients

Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, recently announced the commercial availability of mutational analysis by Next-Generation Sequencing (NGS), which will replace its former mutational analysis platform. NGS joins an extensive collection of tumor profiling technologies currently employed by Caris Molecular Intelligence(TM) Service (MI Profile(TM)), including Immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), restriction fragment length polymorphism (RFLP) and polymerase chain reaction (PCR), providing oncologists the most comprehensive molecular profiling capabilities commercially available today.

MI Profile(TM) offers comprehensive tumor biomarker analyses coupled with an extensive clinical literature evidence review, which matches potential therapies to patient-specific biomarker information. Oncologists are provided simple-to-read reports indicating which available chemotherapeutic, biologic and hormone therapies are potentially effective, along with those that are potentially less effective, based on the molecular profiling results. The report further provides information on appropriate and enrolling clinical trials for the patient. This service presents clinically-relevant, patient-specific information doctors can use to individualize cancer treatment.

Unlike other tumor profiling services on the market, which are often powered by a single technology platform, or hinge on the successful exploitation of a particular DNA mutation, Caris remains both technology- and biomarker-agnostic, employing a wide range of technologies to uncover a broad array of key biomarkers. With this unique approach, the company currently reports potentially clinically-relevant biomarker to drug associations in approximately 95 percent of patient cases, averaging more than 25 possible clinically-actionable biomarkers per patient.

“Evaluating DNA only doesn’t address the true complexity of the biology driving the cancer. It is essential to consider the significant impact of RNA and downstream alterations of the proteins involved in each patient’s disease,” said David D. Halbert, Chairman and Chief Executive Officer of Caris Life Sciences. “It’s imperative to perform a holistic and comprehensive analysis on a tumor, especially the proteins, which are the active agents. Anything less does a disservice to the treating physician and could potentially put a patient at risk.”

“Integrating next-generation sequencing further demonstrates our commitment to continually evolve with emerging science to provide our physicians with an unmatched comprehensive tumor profiling service,” said Tom Spalding, Senior Vice President & Group Head, Oncology, Caris Life Sciences. “As a result of this comprehensive approach, we believe we can provide significantly greater clinical utility than services that solely rely on single technology platforms. For example, NGS analysis alone would not provide oncologists with key insights into some of the most commonly used companion diagnostics, as FDA-approved labeling requires the use of specific and varied profiling technologies.”

NGS will power the mutational analyses performed in the company’s Select and Comprehensive profiles, enabling rapid examination and broader detection of somatic mutations across hundreds of hotspots in the cancer genome. Additionally, this critical technology enables the inclusion of emerging biomarkers that may have potential clinical or research applications. The addition of these emerging biomarkers will further enhance the utility of the Caris Registry®, which houses critical data on biomarker, drug and patient outcomes that may yield greater insights into the treatment of various cancers.

“From both breadth of information and research utility perspectives, NGS is most valuable when combined with other technologies like IHC and FISH to more comprehensively assess a patient’s tumor,”said Sandeep Reddy, M.D., Clinical Professor of Medicine at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and Senior Medical Director at Caris Life Sciences. “Sequencing alone may provide relevant results in smaller percentages of cancer patients, giving the treating physician only part of the full molecular picture. In contrast, Caris provides more meaningful biomarker analysis and delivershighly thorough interrogation of important biomarkers in the cancer pathway. Additionally, Caris’ approach also allows for compliance with FDA labeling on approved companion diagnostics.”

With more than 45,000 patients profiled to date, Caris Life Sciences houses the most comprehensive collection of biomarker profiles in the industry today. Beyond obvious research implications, this extensive database provides clinicians with critical information about the prevalence of biomarkers in unexpected disease states, allowing them to select personalized, tailored therapy regimens for their patients.

Source: Caris Life Sciences

Rosetta Genomics Reports Study Comparing microRNA Profiles of Cancer of Unknown Primary and Metastases of Known Primary Tumors Published in Clinical Experimental Metastasis

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announced last week that data from a study assessing the differences between cancer of unknown primary (CUP) and metastatic solid tumors of known primary metastases (KPM) by profiling microRNA expression were recently published in Clinical Experimental Metastasis, in an article entitled “Global microRNA profiling in favorable prognosis subgroups of cancer of unknown primary (CUP) demonstrates no significant expression differences with metastases of matched known primary tumors.”