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MicroConstants Expands Biomarker Testing and Analysis Services for Preclinical and Clinical Diagnostic Research

MicroConstants, a Contract Research Organization (CRO) specializing in regulated bioanalysis and DMPK, recently announced the appointment of Doinita Serban, Ph.D. as director of biomarker research to oversee the expansion of biomarker testing and analysis services for preclinical and clinical diagnostic research. Doinita’s extensive experience with biomarker assay development, validation, and profiling of disease panels, coupled with the implementation of the Luminex platform, will enable MicroConstants to broaden their biomarker analysis capabilities to include additional assay formats, such as multiplex immunoassays, gene expression and profiling assays.

Kinexus Launches DrugKiNET KnowledgeBase with 105,000 Experimentally Tested Protein Kinase Drug Interactions

Kinexus Bioinformatics Corporation, a world-leader in the study of molecular intelligence systems, announced the launch of its DrugKiNET KnowledgeBase (www.drugkinet.ca) for the identification and development of drug candidates that potently and selectively inhibit human protein kinases. This open-access website features quantitative data on the effects of over 800 chemical compounds on more than 400 protein kinases following careful annotation of hundreds of experiments documented in the scientific literature. This data was then used to train two different proprietary algorithms to predict the inhibitory effects of 550 of these compounds on 500 human protein kinases. This information can guide biomedical researchers in the discovery of new therapeutic targets for existing drugs, and aid in the design of promising new drugs.

At least 538 different protein kinases regulate each other and another approximately 21,500 diverse protein targets to coordinate all of the operations in living cells through complex molecular communications and control networks. Kinases are well recognized by the pharmaceutical and biotech industry as highly productive targets for drug development with applications for cancer, diabetes, Alzheimer’s disease and many other diseases. In fact, over 400 human disease have been linked to genetic mutations in the genes that encode protein kinases or the direct actions of environmental toxins that target protein kinases. Over the last decade, more than two dozen kinase inhibitors have already been approved for clinical use, primarily for cancer treatment. By targeting inappropriately active kinases, these small molecule drugs essentially re-program cancer cells for their demise.

Over the last year, Kinexus and their collaborators in the Mathematics of Information Technology and Complex Systems (MITACS) groups at the University of British Columbia and Simon Fraser University have worked to identify the specific parts of different protein kinases that are critical for recognition by each of 550 different compounds that have been experimentally shown to inhibit one or more kinases. These parts, termed Inhibitor Determining Residues (IDR’s), may be involved in recognizing and binding drugs, and their identification within DrugKiNET can facilitate further optimization of even more potent and specific protein kinase inhibitory drugs. Previously, Kinexus and its partners identified Substrate Determining Residues (SDR’s) in protein kinases that were important for recognition of their protein targets and deposited this information in their open-access PhosphoNET Knowledgebase (www.phosphonet.ca).

“We believe that DrugKiNET is an extremely unique and powerful resource for the biomedical research community,” commented Dr. Steven Pelech, President and Chief Scientific Officer of Kinexus and a professor in the Department of Medicine at the University of British Columbia. “Over a third of all pharmaceutical drug development is presently focused on protein kinase inhibitory drugs, but we expect this to increase even more, since the vast majority of protein kinases have yet to be pursued as drug targets, and definition of the precise roles of different kinases in non-cancer-related diseases is still in its infancy.”

Dr. Pelech added, “We are excited by the prospect that our algorithms can define new protein kinase targets for existing drugs, and that they can identify in the genes that encode protein kinases the specific mutations that may alter their sensitivities to these drugs. As Kinexus has the capability of testing the effects of drug candidates on over 350 different purified protein kinases in-house, we also have the ability to experimentally validate many of our drug predictions for our clients.”

Kinexus is a private, biotechnology company engaged in the research and development of innovative methods to map, track and manipulate cellular communication networks. The application of this knowledge positions Kinexus and its clients in drug development, rational drug design, disease diagnosis and personalized therapies to improve human health. Kinexus currently has agreements with over 1700 research laboratories in companies, universities, government institutions and hospitals in over 35 different countries. To learn more about the diverse proteomics and bioinformatics services offered by Kinexus, please visit www.kinexus.ca or call toll-free at 1-866-KINEXUS.

Source: Kinexus Bioinformatics Corporation

Saladax Receives CLIA Laboratory Certification and Approval to Begin Clinical Laboratory Operations in Support of MyCare Portfolio

Saladax Biomedical, Inc., a privately held company developing novel diagnostic tests that individually optimize a patient’s exposure to chemotherapy, today announced it has been certified as a registered CLIA Laboratory from the Office of Clinical Standards and Quality (OCSQ), a division of The Centers for Medicare & Medicaid Services (CMS) that regulates laboratory testing performed on humans. The CLIA certification and approval marks a significant milestone for Saladax, allowing the company to begin clinical laboratory operations for the MyCare™ portfolio of products at its facilities located in Bethlehem, PA.

Saladax Biomedical Laboratories (SBL), a division of Saladax Biomedical, Inc., will initially offer testing services for chemotherapy exposure optimization assays including My5-FU™, MyPaclitaxel™ and MyDocetaxel™ in the U.S. SBL’s menu of testing services will expand to include more than a dozen new exposure optimization tests that are currently in development.

“This is a significant milestone for SBL as our CLIA laboratory operations are at the heart of our U.S. commercialization plan that will include an expanding suite of MyCare exposure optimization tests that we believe give cancer patients the edge they need with their therapy,” said Mark Myslinski, SVP and Chief Commercial Officer at Saladax Biomedical, Inc. “The SBL team did an outstanding job preparing our company for this milestone and it is illustrative of their preparedness for the commercial launch of the MyCare portfolio to oncologists in the U.S.”

Beginning on July 1, 2013, SBL will offer testing services for their initial chemotherapy exposure test portfolio, MyPaclitaxelTM, MyDocetaxelTM and the My5-FUTM test (previously OnDose) that is being transitioned from Myriad Laboratories. The MyCare technology platform offers, rapid, robust and cost-effective blood tests for patient-specific chemotherapy dose optimization.

As a simple blood test, MyCare products will provide oncologists with vital information to determine the optimal chemotherapy dose required to maximize effectiveness and limit toxicity for their patients on an individual basis.

About Saladax Biomedical, Inc.
Saladax Biomedical develops novel diagnostic assays for the practical delivery of personalized medicine. The company’s proprietary line of MyCare™ assays improves the efficacy of existing drugs by optimizing the dose administered for each individual patient. The initial focus of Saladax is oncology, with a portfolio of 13 chemotherapy drug assays in various stages of development. The initial portfolio of three assays is currently offered to the oncology community in markets around the world.

The company’s MyCare technology platform is broad and flexible, enabling wide application in many therapeutic categories. This technology also enables Saladax to serve as a valuable partner to pharmaceutical and biotechnology companies in the development of companion diagnostics (CDx), addressing multiple risks and challenges encountered in drug development.

Headquartered in Bethlehem, Pennsylvania, Saladax was founded in 2004 and is ISO 13485:2003 certified.

Source: Saladax Biomedical

Partnership Formed to Explore Personalized Medicine Approach for Amyotrophic Lateral Sclerosis (ALS) Treatments

The ALS Emergency Treatment Fund (ALS-ETF) and Denovo Biomarkers (Denovo) have announced a partnership to explore using Denovo’s technology to identify potential responder groups for drugs being studied in ALS patients. This personalized medicine approach may accelerate drug development in ALS and other life-threatening disorders.
The partnership will integrate Denovo’s pharmacogenomic technology into the analysis of biological samples obtained from expanded access programs (EAP’s) that ALS-ETF sponsors. By identifying genomic biomarkers that correlate with patients’ responsiveness to treatment, the partners seek to identify appropriate patient subsets for the conduct of subsequent trials.

“This exciting relationship with Denovo Biomarkers may accelerate the development of drugs for ALS and may help us provide useful information for patients and physicians,” said Jess Rabourn, Managing Director of ALS-ETF. Dr. Wen Luo, Chief Scientific Officer for Denovo Biomarkers, noted, “This partnership leverages the mission of ALS-ETF and the broad utility of our platform. We hope that our combined efforts will lead to better, more targeted treatments for ALS.”

Source: Denovo Biomarkers

Cenix BioScience and Debiopharm Group Collaborate to Identify Predictive Biomarkers

Cenix BioScience, a leading preclinical contract research provider and technology developer specialized in RNAi-, miRNA- and high content-driven pharmacology, and Debiopharm Group™ (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs, including oncology and companion diagnostics, recently announced that they have signed a research agreement to support Debiopharm in its ongoing efforts to develop novel therapeutic drug candidates.

Under the research framework’s first project, Cenix will apply its leading expertise in combining high throughput screening with high content assays in cultured human cells, to identify predictive biomarkers for Debiopharm preclinical oncology candidates. Multi-parametric microscopy-based readouts established by Cenix using the Definiens XD image analysis platform will be used in a range of human cancer cell models to identify genes and pathways that either enhance or suppress the drug’s therapeutic effects. As such, the study represents another important illustration of Debiopharm’s ongoing drive to integrate cutting edge technologies and powerful post-genomic strategies towards further refining its personalized medicine approach towards the development of new therapeutics.

“We very excited to launch this new relationship with Debiopharm, extending their repertoire with what we consider to be some of the most strategically powerful cell-based screening paradigms developed to date,” said Dr. Christophe Echeverri, CEO/CSO of Cenix BioScience. “We deeply appreciate and are particularly gratified by this implied trust from yet another world-class and forward-leaning drug development organization, who also happens to be a long-standing expert in R&D outsourcing”.

“We look forward to working with Cenix, whose specialist expertise, longstanding leadership and unrivaled track record in this field made them an ideal partner,” commented Dr. Hiroaki Tanaka, Director of Personalized Medicine, Debiopharm. “The opportunity to benefit from such depth of knowledge, experience and extensively validated capabilities is considered as the most strategically important resource for preclinical biomarkers discovery”.

Source: Cenix BioScience