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VolitionRx-led Consortium Awarded €780 000 ($1M approx.) Eurostars Grant

VolitionRx Limited (OTC: VNRX), a life sciences company focused on developing blood-based diagnostic tests for different types of cancer, is lead partner of a consortium in a project valued at €779,493 (approx. US$1M) under the EUREKA Eurostars scheme. The project aims to develop new applications of the Nucleosomics biomarker technology in inflammatory disease. The research will build on VolitionRx’s ongoing cancer diagnostic research program.

VolitionRx’s contribution to the project is to develop novel NuQ® biomarkers for immune response. VolitionRx will use its proprietary Nucleosomics® platform for biomarker development exploiting UK-based Alcyomics’ proprietary ex-vivo SkimmuneTM model.

The Eurostars Programme is a European innovation program managed by EUREKA. It is the first program dedicated to supporting research-based small- and medium-sized companies (SMEs) from across Europe. To be eligible for the grant, companies must form a consortium of at least two companies from different European countries, with the aim of developing a civilian-purposed new product, process or service.

“The Eurostars scheme is a prestigious European program designed to support SMEs like VolitionRx, and to encourage cross-border research and development collaboration,” says Mark Eccleston, VolitionRx’s External Collaborations Manager. “We are looking forward to working with our partners to develop novel applications for our Nucleosomics technology, while complementing our ongoing research in cancer diagnostics.”

Under the grant, VolitionRx will be reimbursed with 80% of the costs associated with its share of the joint project – €420,000 ($0.56M approx.) over two years.

Source: VolitionRx Limited

Nodality, Inc. Reports Promising Rheumatoid Arthritis Study Results to Predict Patient Treatment Response to TNF Inhibitors

Nodality, Inc., an innovative biotechnology company advancing discovery, development and use of transformative therapies by revealing functional systems biology, recently announced results of the Company’s comprehensive research study to identify cell markers (biomarkers) of disease activity and treatment success in rheumatoid arthritis (RA) patients. The study findings demonstrated that Nodality’s SCNP technology, which measures functional pathways at the single cell level, can be used to identify biomarkers of responsiveness to treatment with tumor necrosis factor inhibitors (TNFIs). RA affects an estimated two million Americans, and TNFIs constitute the most commonly prescribed therapy. Approximately half of patients respond to treatments such as TNFIs, leaving a substantial unmet need to identify which patients are more likely to respond to current therapies. Optimizing use of currently available therapies could potentially delay tissue damage and progression of disease.

SCNP provides the core technology foundation for Nodality’s programs dedicated to improving clinical medicine by increasing the efficiency of therapeutic R&D programs, enhancing life cycle management for commercialized drugs, and introducing new predictive diagnostics. The study results were featured in an oral presentation titled, Comparison of functional immune signaling profiles in peripheral blood mononuclear cells (PBMC) from rheumatoid arthritis (RA) patients versus healthy donors (HD) using Single Cell Network Profiling (SCNP) (Abstract W7.02.04), at the 15th International Congress of Immunology (ICI) in Milan, Italy, taking place August 22 to 27, 2013. The findings were presented by S. Louis Bridges, Jr., M.D., Ph.D., Marguerite Jones Harbert-Gene V. Ball, MD Professor of Medicine, Director, Division of Clinical Immunology and Rheumatology, University of Alabama School of Medicine.

“Nodality’s research program demonstrates the great promise and potential in gaining a better understanding of disease biology and applying this to the development of prognostic and predictive biomarkers for autoimmune diseases such as RA,” commented Alessandra Cesano, M.D., Ph.D., Chief Medical Officer of Nodality. “I look forward to the final results of this program, one of the most comprehensive of its kind. Our technology, based on immune-biology, can predict which RA patients will respond to specific therapies and reveal the mechanisms of drug resistance, thus informing alternative therapeutic strategies.”

The Nodality research program compares healthy and diseased peripheral blood cells at the single cell level, studying samples obtained through the national Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository (TETRAD). Nodality anticipates completing its research program and announcing the key findings later this year.

Laura Brege, Nodality’s President and Chief Executive Officer, stated, “ICI has provided an important opportunity to showcase one of our key programs in immunology, further validating our broadly enabling SCNP platform. This platform has led to major collaborations in immunology addressing significant unmet needs among patients, as well as new predictive diagnostic modalities in blood cancers. Ultimately, Nodality’s goal is to accelerate and make more efficient the development of new therapeutic agents for serious diseases affecting large patient populations within immunology and oncology, two areas of continuing significant unmet clinical need.”

Additional program results were featured in a second oral presentation at the ICI Congress in a presentation titled, Functional proteomic interrogation of immune cell crosstalk and the effects of cytokine-targeted inhibitors using Single Cell Network Profiling (SCNP) (Abstract W7.02.03).

Source: Nodality, Inc

Mount Sinai and Exosome Diagnostics Partner to Accelerate Translation of Body Fluid Molecular Diagnostics to Overcome Limitations of Tissue Biopsy in Areas of Critical Unmet Medical Needs

The Icahn School of Medicine at Mount Sinai and Exosome Diagnostics today announced a collaboration on the research and development of real-time nucleic acid-based body-fluid diagnostics to advance personalized medicine. Exosome will provide technical and development support to Mount Sinai researchers along with early access to proprietary technology products upgrades. The agreement will allow Exosome and Mount Sinai to establish targeted research and biomarker discovery programs in oncology, inflammation and other disease areas. Exosome anticipates pursuing commercial development and FDA review of successful validations for in vitro diagnostics.

“This collaboration represents the model that research centers and private companies need to adopt in the post-recession, sequestered economy to develop diagnostic products that can improve clinical outcomes, help advance drug development programs and help lower healthcare costs,” said James McCullough, Chief Executive Officer of Exosome Diagnostics. “New York State has taken an aggressive and appropriate approach to promoting cooperation of its leading research centers, such as Mount Sinai, with private industry resources and commercial capability to drive translational medicine. Mount Sinai and Exosome together can accelerate cutting-edge diagnostic products to serve the clinical market.”

Carlos Cordon-Cardo, MD, PhD, Chair, Department of Pathology, Icahn School of Medicine at Mount Sinai, added, “As we advance our precise medicine program in the Departments of Pathology and Genomics at Mount Sinai, biofluid-based, point-in-time analyses, made possible by the Exosome Diagnostics-Mount Sinai relationship, will undoubtedly lead to an improved, patient-centric understanding of disease, thereby guiding more informed treatment decisions and response to therapy.”

The agreement was negotiated by Mount Sinai Innovation Partners (Mount Sinai IP), which encourages the commercialization of novel research conducted at the Icahn School of Medicine at Mount Sinai. Mount Sinai plans to leverage the considerable expertise of its clinical investigators in areas of key unmet medical needs to develop clinical study programs taking advantage of Exosome’s unique technology that has the ability to extract high-quality RNA from blood, urine and cerebrospinal fluid.

Under the agreement, Mount Sinai will retain rights to molecular biomarkers associated with disease progression and drug response, and Exosome will retain commercial development rights for molecular in vitro diagnostic products. The collaboration will extend for five years. Dr. Cordon-Cardo receives financial compensation from Exosome Diagnostics as a member of its scientific advisory board.

Source: PR Newswire

ImmusanT Initiates Study at Joslin Diabetes Center to Investigate Relationship Between Celiac Disease and Type 1 Diabetes

ImmusanT recently announced that it has initiated a clinical research study to explore the immunologic relationship between celiac disease and Type 1 diabetes (T1D) and to further understand the underlying cause of T1D. The research will focus on characterizing immune responses in patients affected by both T1D and celiac disease. The study will be performed by the Joslin Diabetes Center.

It is estimated that celiac disease affects about one in 100 Americans, but in people with T1D about one in 10 are affected by the disease. Celiac disease is caused by an immune response to dietary gluten, but the trigger for the immune response causing T1D is not as clear. Studies suggest that genes putting people at risk of T1D and celiac disease are the same, and shared by several other common autoimmune diseases. Further research into whether the immune response causing celiac disease is related to the autoimmune response causing T1D may reveal new information about autoimmune disease in general.

The study with Joslin will assess patients with celiac disease only and patients who have both celiac disease and T1D. The goal of the study is to compare biomarker response in both sets of patients, which may elucidate drivers of T1D. In the long-term, this study could provide insights into potential treatments for T1D.

“Type 1 diabetes and celiac disease appear to be closely related, so it is natural that the next disease that ImmusanT would examine is T1D,” noted Bob Anderson, Chief Scientific Officer of ImmusanT and the inventor of Nexvax2®. “By better understanding the mechanisms that are common to T1D and celiac disease, we may be able to leverage our expertise gained from developing Nexvax2 to identify a way to halt or prevent the autoimmune response in patients with Type 1 diabetes.”

“ImmusanT pioneered the development of the only antigen-specific immunotherapeutic approach to celiac disease and we are eager to broaden our knowledge with others to uncover mechanisms common to other immune diseases,” commented Leslie Williams, President and Chief Executive Officer of ImmusanT.

Source: PR Newswire

Breakthrough Case Study Highlights New Biomarker for Cancer and Inflammation

A groundbreaking peer reviewed case report by Dr. Isaac Eliaz, M.D. of Amitabha Medical Clinic, demonstrates for the first time the clinical use of novel biomarker galectin-3 to assess cancer progression and inflammation. The case study titled, “The Role of Galectin-3 as a Marker of Cancer and Inflammation in a Stage IV Ovarian Cancer Patient with Underlying Pro-Inflammatory Comorbidities,” was published in the July 2013 issue of Case Reports in Oncology. This report is the first of its kind to expand the diagnostic and prognostic applications of the galectin-3 blood serum test, introducing an important clinical tool to assess risk and progression of metastatic cancer and inflammatory diseases.

In 2011, the galectin-3 blood test was approved by the U.S. Food and Drug Administration for the screening and prognosis of congestive heart failure and cardiovascular disease. Approval was granted after an extensive body of published data, including long-term population studies, demonstrated the active role of elevated galectin-3 in cardiovascular conditions, fibrosis and early mortality. However, a rapidly expanding field of published galectin-3 research also highlights the significance of this rogue molecule as a novel biomarker that is both an active culprit as well as a byproduct of numerous inflammatory and malignant cellular processes beyond cardiovascular disease.

An expert on galectin-3, Dr. Eliaz applies the data obtained in this case study to shed further light on excess galectin-3’s mechanisms of action, specifically inflammatory response to injury and cancer progression. In this report, Dr. Eliaz presents the first published case documenting the clinical use of galectin-3 to monitor cancer progression and treatment response, as well as inflammatory conditions. These findings point to an expanded clinical model using galectin-3 testing in the diagnostic and prognostic assessment of numerous chronic, inflammatory diseases.

Unlike biomarkers such as C-reactive protein (CRP), which only indicate the presence of inflammation, galactin-3 is shown to play a direct role in initiating disease progression. It is a protein normally present in the body at low concentrations, where it is involved in numerous functions including cell growth and communication. At elevated levels, however, galectin-3 fuels numerous pathologic processes including chronic inflammation and the progression of inflammation to fibrosis; cancer cell adhesion, migration, angiogenesis, and metastasis. Elevated galectin-3 also allows cancer cells to evade immune response. Research demonstrates elevated galectin-3 levels in patients with melanoma, lung, breast, prostate, colorectal, ovarian, and head and neck cancers as well as non-Hodgkin’s lymphoma and others. Galectin-3 levels are also found to be higher in patients with metastatic disease than in patients with localized tumors.

Dr. Eliaz states, “This new case report and significant clinical observation supports the need for further research on the role of galectin-3. The galectin-3 test could well become one of our most important clinical tools in assessing and monitoring a wide range of conditions beyond cardiovascular disease, including metastatic cancer and inflammatory conditions.”

Study: The Role of Galectin-3 as a Marker of Cancer and Inflammation in a Stage IV Ovarian Cancer Patient with Underlying Pro-Inflammatory Comorbidities. [Case Reports in Oncology]

Source: PR Newswire