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KineMed Awarded NIH Contract to Identify Biomarkers for Myocardial Fibrosis

KineMed, Inc. (www.kinemed.com) recently announced that the National Heart, Lung, and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), awarded the company a Phase I SBIR (Small Business Innovation Research) contract to develop biomarkers for the detection of early myocardial fibrosis. Biomarkers for myocardial fibrosis will guide disease interventions that block the progression of this disease which is risk factor for heart failure and arrhythmias.

Amplion Research Launches Version 2.0 of BiomarkerBase™, the Database of Clinical Biomarkers, Significantly Expanding Its Ability to Inform Investments in Molecular Biomarkers and Personalized Medicine

BiomarkerBase™ 2.0 now includes every validated biomarker in clinical use, along with a significantly improved user interface and expanded functionality. The team at Amplion Research, publishers of BiomarkerBase™, manually reviewed every IVD test cleared or approved by the FDA since 2000, adding to the extensive set of test, drug, and clinical trial data already included in the database.

“Being aware of all existing clinical applications for molecular biomarkers is an important part of the groundwork for biomarker development projects,” said Adam Carroll, Ph.D., Science Director at Amplion Research. “Our primary goal has always been to give our clients confidence that they have in front of them the complete set of validated clinical biomarkers. To achieve that goal, there is no substitute for manual curation of the data,” said Carroll. “Additionally, all of the linkages between biomarkers and the specific tests, drugs, and trials that define them were each individually reviewed, making BiomarkerBase™ a very robust reference tool.”

Data Enhancements

Along with every validated clinical biomarker, the database also includes every emerging clinical biomarker disclosed in a phase 3 or 4 clinical trial, and will soon include all phase 1 and 2 trials as well. BiomarkerBase™ also now includes publications in its dataset for the first time, and most biomarkers in the database include the total number of published clinical studies for each biomarker, with full publication details for the 10 most recent. Additional enhancements to published clinical data and data from other sources are already in progress.

Interface Enhancements

Biomarkers can now be browsed by target, disease, drug, company, or therapeutic area, and every IVD test, drug label, and clinical trial that includes the biomarker is listed, with direct links to the primary records at FDA and NIH. BiomarkerBase™ has a clean and intuitive interface that makes browsing biomarkers and their related information fast. The database is, at the same time, very well connected, both internally and externally, making it easy to follow the key links between different information types.

Stakeholders in biomarker projects at drug companies, diagnostics companies, contract research organizations, technology transfer offices, and investment firms are all using BiomarkerBase™ to stay on top of every clinical application for a molecular biomarker; every drug label that includes a biomarker; and every clinical trial that includes a disclosed biomarker.

Source: Business Wire

Venaxis Appoints SomaLogic CMO and former Pfizer Executive Stephen A. Williams, M.D., Ph.D., to Board of Directors

Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, protein biomarker-based assay for appendicitis, recently announced the appointment of Stephen A. Williams , M.D., Ph.D., Chief Medical Officer at SomaLogic, to the Company’s Board of Directors. Dr. Williams brings his experience in diagnostic imaging and biomarker discovery to the Venaxis Board.

Steve Lundy , President and CEO of Venaxis, stated, “We are happy to welcome Steve to our Board and look forward to the benefit of his deep experience, both in diagnostic imaging, which is relevant to our market development and commercial strategy for the APPY1 Test, as well as in clinical biomarker validation, which will be instrumental to us in our evaluation and development of future Venaxis products.”

Dr. Williams stated, “The APPY1 Test is an excellent example of how characterization of clinically relevant biomarkers can produce useful tools for addressing important diagnostic challenges. With the potential to reduce the safety risks associated with current diagnostic imaging techniques in the emergency setting, I believe there is significant clinical need and utility for the APPY1 Test. I am excited to join the Venaxis Board and to support the further development and commercialization of this, as well as potential future, biomarker-based diagnostic products.”

Dr. Williams joined SomaLogic in 2009 as Chief Medical Officer. Prior to his time at SomaLogic, Dr. Williams trained as a physician at Charing Cross and Westminster Medical School, University of London, and following his internships, returned to the same institution for a Ph.D. in medicine and physiology. He subsequently performed three years of residency in diagnostic imaging at the University of Newcastle upon Tyne. In 1989 he joined Pfizer U.K. in experimental medicine and worked on a variety of programs including asthma, irritable bowel syndrome, migraine [eletriptan], depression [sertraline] and urinary incontinence [darifenacin]. He moved to the U.S. in 1993 with Pfizer and worked on programs in inflammatory bowel disease, stroke, psychosis [ziprasidone] and head injury. He created the clinical technology group in 1997, which became a worldwide function on five research sites with the objective of validating clinical biomarkers and measurements, and was named vice president in 2006. Dr. Williams served on the National Advisory Council for the National Institute of Biomedical Imaging and Bioengineering from 2004-2007 and the executive Committee of the Biomarkers Consortium run by the Foundation for NIH from 2005-2007. In process initiatives, he led or co-led initiatives in diagnostics, biomarkers, quality of drug candidates, and guidelines for development teams to make the decision to start Phase 3 trials.

Source: PR Newswire

Investment in a Quebec Public-private Partnership to Support the Use of Personalized Medicine Solutions in the Treatment of Cancer Patients

The Government of Québec announced today a $10 million investment in the Personalized Medicine Partnership for Cancer (PMPC). This public-private partnership will be focused on establishing an integrated approach for the development and implementation of clinical biomarkers and other personalized healthcare solutions to improve the outcome and cost-efficiency of healthcare services provided to cancer patients in the province of Québec and abroad. The investment, to be disbursed over a 4 year period, will be supplemented with $11.1 million of funding from the private sector partners, for a total project value of $21.1 million.

The PMPC will be under the leadership of Caprion Proteome Inc., a Montreal-based biotech company specializing in the discovery and development of protein-based diagnostic biomarkers. The other partners will include the Québec Clinical Research Organization in Cancer (Q-CROC), a multidisciplinary network of clinicians, academic scientists and other members of the medical community involved in clinical and translational cancer research, as well as private partners Oncozyme Pharma Inc., Pfizer Canada Inc., Sanofi Canada Inc. and TELUS Health.

As part of the projects supported through this partnership, state-of-the-art genomic, proteomic, bioinformatic and information technology platforms will be implemented to develop and deploy novel biomarkers and targeted therapeutic strategies in the healthcare system for the treatment of lung, colon and breast cancers: “The sequence of our genome or the profile of the proteins in our blood can be used to accurately predict disease progression or treatment outcome. Our partnership will integrate advanced technology platforms with clinical research to accelerate the development and clinical deployment of novel personalized healthcare solutions. Caprion has pioneered such strategies for years, and with our partners, we are committed to delivering tangible results to provide more targeted diagnosis and treatments for cancer,” said Martin LeBlanc, President and Chief Executive Officer of Caprion Proteome.

Personalized medicine has been coined to describe the use of specific patient information gathered from tumour, blood or other specimens to characterize disease subtype and select the optimal treatment. “The rapid progress in clinical research enables us to decipher the underpinnings of cancer and to develop specific diagnostic tools and targeted drugs to treat specific subtypes of common cancers such as lung, colon or breast. It is critical that these new tools and medicines be deployed for the benefit of patients across Québec,” said Gerald Batist, Professor of Oncology at McGill University and Co-director of the Q-CROC and Director of the Segal Cancer Center at the Jewish General Hospital. “While technology has been progressing rapidly, it will be critical to prepare our healthcare system to integrate the wealth of new molecular information and educate professionals in the practice of personalized medicine,” he added.

The PMPC project stemmed from the Stratégie québécoise de la recherche et de l’innovation (SQRI) that was created by the Government of Québec to advance knowledge and accelerate the deployment of innovative personalized medicine solutions to the bedside. The partnership, in collaboration with the Ministère de la santé et des services sociaux (MSSS), was also built to strengthen the cooperation between the private and the public research sectors including academic healthcare institutions and universities.

Source: PR Newswire

Arno Therapeutics Reports Progress in Development of Clinical Biomarkers to Support Treatment of Breast Cancer with Onapristone

Arno Therapeutics, Inc. (OTCBB: ARNI) recently reported progress in its clinical biomarker program to develop a companion diagnostic with onapristone in the treatment of breast and other cancers. Onapristone is the company’s investigational progestin receptor antagonist that has demonstrated anti-tumor activity in preclinical and clinical studies of hormone-dependent tumors.