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Researchers Discover Biomarker, Potential Targeted Therapy for Pancreatic Cancer

University of Cincinnati (UC) researchers have discovered a biomarker, known as phosphatidylserine (PS), for pancreatic cancer that could be effectively targeted, creating a potential therapy for a condition that has a small survival rate.

Quintiles Releases Perspectives on Early Phase Oncology and Hematology Biomarkers

In advance of the American Society of Clinical Oncology (ASCO) Annual Meeting, Quintiles recently announced the release of its perspective on two areas of focus for clinical oncologists – the impact of patient selection in early-phase studies and the use of biomarkers in the treatment of hematologic malignancies.

The first of these reports, Tomorrow’s Path to Improved Early-Phase Oncology Drug Development, explores the importance of key elements to maximize quality and efficiency of go/no-go decisions in early-phase studies. As the understanding of the biology of cancer becomes more sophisticated and generates more opportunities, fundamental challenges caused by the complexities of this group of diseases are becoming more evident. Molecular profiling and leveraging molecular selection of patients has the potential to significantly improve the quality of early decisions in oncology drug development.

“By identifying a well defined group of patients with a particular molecular biological profile, we have the potential to make more efficient decisions on product candidates at the earliest possible stage,” said Philip Breitfeld, M.D., vice president and therapeutic strategy head, Quintiles. “As the cost of oncology drug development rises, the use of targeted therapies represents a path toward more precise treatment approaches that would drive down costs, timelines and failure rates.”

The second report, Biomarkers: Recent Advances in their Application to the Treatment of Hematologic Malignancies, presents a point of view on the value of biomarkers in the early detection and stratification of groups at risk for aggressive disease to improve the overall survival rates associated with late stage diagnosis.

Hematopoietic malignancies, which include a heterogeneous group of diseases such as multiple myeloma, lymphomas and leukemias, are characterized based on the appearance of the cells as well as demonstrating the presence or absence of certain cell surface proteins (Cluster of Differentiation or CD markers), characteristic chromosomal abnormalities, and by the identification of particular genetic mutations.

“While the use of biomarkers is widely supported and the hope of early detection is promising, few biomarkers have been identified or clinically validated for the early detection, progression or risk assessment for such malignancies,” said Harish Dave, M.D., MBA, vice president, global medical strategy head, hematology and oncology, oncology therapeutic area, Quintiles. “Recent advances in understanding of these malignancies and the advent of high-throughput technologies have the potential to facilitate rigorous translational research toward the discovery, development and clinical validation of novel biomarkers.”

Source: Quintiles

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

Biomarker May Identify Neuroblastomas with Sensitivity to BET Bromodomain Inhibitors

Neuroblastoma, the most common malignant tumor of early childhood, is frequently associated with the presence of MYCN amplification, a genetic biomarker associated with poor prognosis. Researchers have determined that tumors containing MYCN amplification are sensitive to a new class of drugs, BET bromodomain inhibitors.

The researchers made this discovery in a preclinical study, which was funded in part by a Stand Up To Cancer Innovative Research Grant and was published in Cancer Discovery, a journal of the American Association for Cancer Research.

“BET bromodomain inhibitors are a class of drugs that many researchers are hopeful may offer a new therapeutic option for treating patients with certain cancers,” said Kimberly Stegmaier, M.D., assistant professor of pediatrics in the Department of Hematology/Oncology at Dana-Farber/Children’s Hospital Cancer Center in Boston, Mass. “The challenge has been identifying biomarkers that can help direct clinical translation of these drugs by pinpointing those patients with the highest likelihood of response.”

To identify genetic biomarkers of responsiveness to BET bromodomain inhibitors, Stegmaier and colleagues screened more than 600 cancer cell lines with known genetic characteristics for sensitivity to a prototypical BET bromodomain inhibitor.

Using this high-throughput, cell-based screening process, the researchers found that neuroblastoma cells in which the MYCN gene was amplified were sensitive to BET bromodomain inhibitors.

“Neuroblastoma is a devastating childhood cancer, and only a minority of children with high-risk disease will be cured with currently available treatments,” Stegmaier said. “Prior research has shown that MYCN amplification is common in neuroblastoma, but it has been an elusive drug target.”

To further validate their findings, the researchers tested a BET bromodomain inhibitor, from the laboratory of James E. Bradner, M.D., at the Dana-Farber Cancer Institute, using cultured MYCN-amplified neuroblastoma cell lines and three animal models of MYCN-amplified neuroblastoma. Together, they found that the drug decreased levels of MYCN protein in cultured cells, and that this led to impaired cell growth and cell death. In each animal model, including a mouse model of neuroblastoma that is known to be resistant to many standard therapies, the drug was shown to have anti-tumor effects and to prolong survival.

“My Stand Up To Cancer grant, which focused on modulating difficult drug targets in childhood cancers, was instrumental to us being able to do this exciting work,” Stegmaier said. “These types of studies are generally considered high-risk, particularly because they start with unbiased screening, and they are generally less likely to be supported by traditional sources of funding.”

Study: Targeting MYCN in Neuroblastoma by BET Bromodomain Inhibition

Source: EurekAlert!

Statewide Clinical Trials Network of Texas (CTNeT) Signs Research Agreements with Leading Research Programs Throughout Texas

The Statewide Clinical Trials Network of Texas (CTNeT), a non-profit clinical trials network established to facilitate multi-institutional, collaborative cancer research, announced this week that the organization has signed research agreements with 20 leading cancer research institutions and community-based oncology groups throughout Texas, including all four of the state’s National Cancer Institute designated Cancer Centers and Texas Oncology.