Rapid, Cost-Effective Screening Using Data from Drug-Treated Rat Liver Cells

FOSTER CITY, Calif. & SAN DIEGO–Entelos, Inc., a simulation and modeling company focused on human health, and RegeneMed, Inc., a tissue-based drug discovery and regenerative medicine company, announced today the release of iToxFX™.

“For companies with little toxicogenomics expertise or small research budgets, iToxFX provides a quick analysis of a new drug’s potential safety profile, identifying likely mechanisms of toxicity much earlier in the development process. This ‘fail early, fail fast’ approach helps clients save time and money.”

iToxFX helps pharmaceutical companies rapidly screen novel compounds for potential toxicity issues, one of the leading causes of drug failure in the complex and costly process of discovering and developing new medicines.

“In traditional toxicology, adverse events and potential side effects are often discovered relatively late in drug development, making it a costly endeavor,” said Alan Roter, Vice President of Informatics at Entelos. “For companies with little toxicogenomics expertise or small research budgets, iToxFX provides a quick analysis of a new drug’s potential safety profile, identifying likely mechanisms of toxicity much earlier in the development process. This ‘fail early, fail fast’ approach helps clients save time and money.”

In contrast to classical toxicology approaches that take weeks or months, iToxFX can rapidly analyze the toxicogenomic profile of drug-treated rat hepatocytes (liver cells) and generate analytical reports within minutes. RegeneMed is a preferred provider of primary hepatocyte cultures and services.

“Translation of gene expression databases to in vitro systems has been limited by poor reproducibility of primary culture techniques,” said Dawn Applegate, President and CEO of RegeneMed. “In partnership with Entelos, we have demonstrated lot-to-lot consistency in toxicogenomic profiles from RegeneMed hepatocyte cultures. This enables high-content, high-throughput application of the current in vivo-based ToxFX® platform to in vitro data using iToxFX.”

Key advantages of iToxFX include:

– Screening compounds more rapidly and cost-effectively than conventional animal studies

– Testing a large number of candidate drugs from one hepatocyte preparation

– Automatically generating comprehensive analysis reports for each drug, reducing a task that traditionally takes weeks down to mere minutes

– iToxFX leverages Entelos’ powerful DrugMatrix®, a reference database comprised of Entelos-generated data from over 18,000 vehicle and drug-treated animal tissue samples and cultures, based on 600 marketed drugs and toxicology standards.

Toxicogenomics is the science of applying gene expression profiling to understanding mechanisms of toxicity. The iToxFX and ToxFX software work exclusively with Affymetrix® GeneChip® microarrays, and the ToxFX Analysis Suite was developed as a collaboration between Entelos and Affymetrix. ToxFX and iToxFX are trademarks of Entelos, Inc. Affymetrix and GeneChip are registered trademarks of Affymetrix, Inc.

About Entelos:

Entelos, Inc. is a life sciences company applying next-generation predictive technologies to revolutionize the way medicines are discovered, developed, and utilized. The Company leverages its proprietary “virtual human” computer simulations of disease, and toxicology reference systems to develop safer and more effective drugs, improve the quality of health-related consumer products, and deliver on the promise of personalized medicine. Entelos provides customized products, technology and research services to global pharmaceutical, health-care, and consumer products companies in safety testing, arthritis, cardiovascular diseases, asthma, obesity, diabetes, hematopoeisis (anemia), cholesterol metabolism, skin sensitization, and personal care products.

About RegeneMed:

RegeneMed, Inc. is a tissue engineering and regenerative medicine company leveraging its patented core technology to create tissues for application to drug discovery, biosensors, diagnostics, medical devices and tissue implants. RegeneMed accelerates the development of safer, more effective drugs by providing three-dimensional, human and animal tissue cultures in high throughput and high content platforms to serve as more physiologically relevant replacements to current industry-standard animal and cell-based tests that have limited human drug toxicity prediction. RegeneMed currently provides human and animal tissue cultures from liver and skin, as well as contract testing services for safety and efficacy evaluation.

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