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Experimental Therapeutics Centre and Debiopharm Group to Collaborate for the Development of an Epigenetic Innovative Oncology Target

The Agency for Science, Technology and Research (A*STAR)’s Experimental Therapeutics Centre (ETC), a center of excellence to advance and accelerate drug discovery in Singapore, and Debiopharm Group™ (Debiopharm), the Swiss-based global biopharmaceutical company that focuses on the development of prescription drugs that target unmet medical needs including oncology as well as companion diagnostics, recently announced the signature of an exclusive research collaboration to develop oral small molecules targeting new class of epigenetic modulators.

Under the terms of the agreement, Debiopharm and ETC will co-finance the discovery phase of the project, whilst Debiopharm will be in charge of development.

Genomind Announces New Portal at NEI Global Psychopharmacology Congress

Genomind, a personalized medicine company for neuropsychiatry, is excited to announce its new clinician online portal at the Neuroscience Education Institute (NEI) Global Psychopharmacology Congress in San Diego. Genomind will host a Product Theater at the Congress on Saturday, October 20, 2012 at 7 am, where co-founder and Chief Scientific Officer Dr. Jay Lombard will discuss the Company’s Genecept Assay, introduce attendees to the new system, and showcase the convenient features for clinicians.

The portal is a secure, convenient way for clinicians to easily access their patients’ test results from the Genecept Assay. The Assay is Genomind’s comprehensive, saliva-based test, which looks at genes and biomarkers that may affect the type of medication or treatment a clinician would prescribe to patients suffering from difficult-to-treat psychiatric disorders. The secure site allows clinicians to review and download comprehensive reports via login credentials any time or place, giving flexibility to their busy schedules. All results will be available electronically and can be downloaded directly from the portal. The portal also allows easy access to peer-reviewed study data related to genes in the panel.

The portal is also the home of Genomind’s innovative Open Label Study, which measures the real world use and impact of the Genecept Assay on patient treatment and outcomes. The study has a unique design to enable timely, efficient reporting online for clinicians and patients.

The portal will be accessible on the Genomind website homepage or via email alerts sent to clinicians once their patients’ test results are live and available.

The Neuroscience Education Institute Annual Conference runs from October 18-21, 2012, at the Manchester Grand Hyatt in San Diego. In addition to the Product Theater, Genomind will be available on the main show floor at Booth 115 to share more information about the portal, the Genecept Assay, and their dedication to harnessing the latest research to better treat patients.

Source: Genomind

HSS Uses Grant to Test New MRI Techniques & Biomarkers for Arthritis Prevention Treatments

In recent years, researchers have been frustrated because there are no tools to identify early stages of osteoarthritis and thus no good way to test therapies for preventing or slowing the disease. Now, three institutions have been awarded $1 million from the Arthritis Foundation to validate the use of new MRI (magnetic resonance imaging) techniques and newly identified biomarkers to solve this vexing problem. Hospital for Special Surgery in New York City, University of California-San Francisco (UCSF), and Mayo Clinic in Rochester, Minnesota will share the $1 million.

“There is no magic bullet for treatment of osteoarthritis yet, but once we have a potential oral drug, therapeutic injection, or surgery for treating the disease, we will need a way to identify patients who might need it and follow their response to the treatment,” said Scott Rodeo, M.D., orthopedic surgeon and co-chief of the sports medicine and shoulder service at Hospital for Special Surgery (HSS) and co-principal investigator of the tripartite grant. “Using X-rays to measure joint space narrowing is the gold standard for assessing the presence and progression of osteoarthritis, but X-rays are next to worthless for detecting the early changes of arthritis. This study will help us understand the early factors that lead to the degenerative changes in ACL (anterior cruciate ligament) injured knees.”

Acute ACL injury is a major risk factor for developing osteoarthritis. In the past several years, researchers have discovered that long before osteoarthritic changes in joint space can be detected on X-ray, biochemical changes can be detected in cartilage using newer quantitative MRI techniques. Many studies have also shown that ACL injury is associated with quantifiable changes in biochemical biomarkers that can be detected in synovial fluid (joint fluid), blood, and urine.

The Arthritis Foundation grant will be distributed over one year and then the three grant recipients have made an institutional commitment to provide annual patient follow up after that. Each institution will recruit 25 patients who are at a maximum of 14 days out from tearing their ACL. Patients will be evaluated at baseline, six weeks, six months, 12 months and yearly thereafter with traditional MRI and newer MRI techniques.

Specifically, the new quantitative MRI techniques, developed by researchers at HSS and UCSF, measure T1ρ and T2 values of articular cartilage and the meniscus. Articular cartilage is the smooth cushion that lines the end of the bones where they meet at the joints. The meniscus is a knee structure that spans and cushions the space between the joint surfaces of the thighbone and shinbone. In scientific speak, T1ρ measures proteoglycan depletion, and T2 evaluates abnormal collagen orientation. Proteoglycans are conjugates of proteins and long carbohydrate molecules joined together with sugars.

“Imagine you are playing basketball and you jump up to make a basket, your ability to withstand the load when you come down is a function of proteoglycan,” said Hollis Potter, M.D., chief of the division of magnetic resonance imaging, director of research in the Department of Radiology and Imaging at HSS. “If you pivot and throw the ball to someone else, your ability for your cartilage to withstand that load is a function of the collagen. You need both to be healthy.” Dr. Potter is the HSS site leader of the grant.

At each time point that researchers collect MRI data, they will also collect samples of synovial fluid, blood, and urine from patients and evaluate knee function using surveys such as the Knee Outcome Survey, international knee documentation committee (IKDC) evaluation forms, and Marx Activity Level. These surveys gauge whether a patient has knee impairment; the degree of symptoms such as knee swelling and pain; and how much knee impairment impacts overall well-being, daily living, work, and athletic and social activities. The majority of participants in the study will undergo ACL reconstruction, and surgeons will evaluate these patients arthroscopically at the time of the operation. Clinicians will correlate fluid biomarkers and quantitative MRI results with traditional imaging, clinical, and functional outcomes.

Osteoarthritis is an extremely heterogeneous disorder in terms of the factors that contribute to the loss of joint function. Researchers need to be able to identify where a patient is in the progression of the disease to be able to target specific processes that are responsible for the symptoms and loss of joint function.

“Not everyone who has an ACL tear will develop osteoarthritis, but some do,” said Dr. Rodeo. “The goal is to identify biomarkers that reflect alterations in the joint environment that may be predictive of developing arthritis.” Once these are identified, researchers can test therapies to slow or prevent the disease, which can be crippling and lead to disability.

“There remain many unanswered questions regarding the optimal care of patients with ACL injuries,” said Steven Goldring, M.D., Chief Scientific Officer, St. Giles Chair, Hospital for Special Surgery. “This study is a paradigm of interdisciplinary research that brings together experts in orthopedics, radiology and basic science from multiple leading medical centers with the single goal of developing the most effective therapies to improve outcomes in patients with ACL injuries. The Arthritis Foundation should be congratulated in initiating this groundbreaking program.”

ACL ruptures affect roughly 1 in 3,000 people per year in the United States alone. The cumulative population risk of an ACL injury in people between the ages of 10 and 64 years has been estimated to be 5%, but could be considerably higher. More than 175,000 ACL reconstructions are performed each year in the United States at a cost of $2 billion. Participation in sports that involve pivoting including soccer, basketball, football, and skiing put individuals at higher risk for tearing their ACL.

Source: EurekAlert!

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

Genalyte and Barbara Davis Diabetes Center Collaborate to Advance Multiplexed Antigen Panel for Early Diagnosis of Type 1 Diabetes

Genalyte, Inc. recently announced the launch of its Type 1 Diabetes (T1D) antigen panel that runs on the Maverick Detection System. The Genalyte T1D antigen panel is the first multiplexed assay that measures seven autoantibodies associated with the destruction of pancreatic islet cells seen in type 1 diabetes. In a related development, Genalyte reported that it is collaborating with the Barbara Davis Center for Childhood Diabetes (BDC) at the University of Colorado School of Medicine to further develop and test multiplexed antigen panels for the early detection of T1D.

The Genalyte T1D antigen panel was developed as part of the first phase of a Small Business Innovation Research (SBIR) grant awarded to Genalyte to develop multiplexed assays for the early detection and monitoring of type 1 diabetes. The $500,000 grant from the National Institute of Diabetes and Digestive and Kidney Diseases also provides support for expansion of the approach to allow autoantibody response profiling by multiple criteria, which is expected to enhance the ability of researchers and clinicians to detect and monitor the development of the disease.

Martin Gleeson, PhD, Chief Scientific Officer of Genalyte, noted, “The pioneering work of Drs. George Eisenbarth and Liping Yu at BDC established assays for the measurement of islet autoantibodies. These rogue elements of the immune system eventually destroy the pancreatic islet cells that produce insulin. The unique capabilities of our Maverick detection platform have the potential to provide researchers and clinicians with tools to detect and track this process from an early stage, when interventions to interrupt the disease process may be feasible.”

An estimated three million individuals in the U.S. have T1D, an autoimmune disorder that leads to life-long dependence on insulin injections. New disease-modifying therapies may have the potential to reduce or stop the destruction of islet cells in patients at risk of developing T1D. The availability of tools to identify these patients early in the disease process would facilitate the development and use of these preventative therapies.

“We are pleased to offer our innovative T1D antigen panel to diabetes researchers worldwide at the same time that we are working with Dr. Liping Yu and his lab at the Barbara Davis Diabetes Center to expand the utility of the approach,” added Dr. Gleeson. “BDC is a long-time leader in the quest to develop curative therapies for type 1 diabetes, and we are delighted to collaborate with them to develop the tools that may help make this dream a reality.”

The Genalyte T1D antigen panel requires only a 2 to 5 μL serum or plasma sample and provides results in less than 15 minutes, without the use of dyes, fluorescent probes or radioactive labels. The T1D panel measures autoantibodies to insulin, proinsulin, GAD 65, GAD 67, IA-2 (PTPRN, ICA512), phogrin (PTPRN2, IA-2ß) and ZnT8 (SLC30A8). For more information, visit http://genalyte.com/maverick-type-1-diabetes-t1d-assay-kit/.

Other commercially available tests for the Maverick Detection System include MT-ADA, ENA 4, ENA 6 and ANA 14 assay kits. Additionally, Genalyte offers researchers a Custom Spotting Service that loads proteins supplied by customers, such as antibodies, peptides, biomarkers, cytokines and antigens, on to standard-format Genalyte chips that are ready to be run on the Maverick System.

Maverick assays are currently available for research use only.

Source: Genalyte