FDA signs contract with Entelos to Predict Cardiovascular Adverse Events
Foster City, CA, December 16, 2008 - Entelos, Inc. (LSE: ENTL), the leader in predictive disease simulation for pharmaceutical, health-care and consumer products applications, today announced that it has entered into an agreement with the U.S. Food and Drug Administration (FDA) to use the Entelos® Cardiovascular PhysioLab® to assess the cardiovascular safety and efficacy of a specific drug class and a set of drugs within that class. The compound class and specific set of drugs were not disclosed.
The Company’s Cardiovascular PhysioLab platform is a comprehensive large-scale computer simulation of cholesterol regulation, atherogenesis, and cardiovascular risk. It has been used by Entelos for multiple pharmaceutical customers to simulate and predict the effects of drugs in patients and patient populations, evaluate novel drug targets, test combination therapies, identify and interpret biomarker patterns, and predict a drug’s long-term biological effects.
"Although the modern controlled clinical trial is still the international gold standard for evaluating safety and efficacy of new therapies, rare and serious adverse events may only appear after a drug has been administered to a large heterogeneous population, long after it has been approved," said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. "Having information that may be predictive of likely adverse events or that can help to explain the biological mechanisms leading to adverse events in certain patient types could be extremely valuable. This project will thus test the predictive value of using a dynamic, mechanistic computer model of cardiovascular disease processes and a large virtual patient population for detecting rare adverse events."
A broad range of "virtual patients" will be generated using Entelos’ cardiovascular platform and used for simulations to test the cardiovascular safety and efficacy of multiple drugs. Results will be compared to existing clinical trial data collected by the FDA from multiple drug sponsors. Insights will help to inform the FDA on key decisions concerning the effects of novel drugs on cardiovascular disease processes.
"We believe that Entelos is uniquely positioned to deliver a high impact project to the FDA in this most significant area of drug safety," said James Karis, President and CEO of Entelos. "We look forward to prospectively predicting the results, both safety and efficacy, of ongoing cardiovascular trials before their submission for approval, and to helping determine whether adverse events are due to specific compounds or to an entire drug class. We believe that this could make an impact not only on drugs for cardiovascular indications, but for any drugs with potential effects on the cardiovascular system."
Entelos, Inc. (www.entelos.com) is a US-based life sciences company applying next-generation predictive technologies to revolutionize the way medicines are discovered, developed, and utilized. The Company leverages its proprietary in silico disease models, "virtual human" technology, 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.
Posted: December 2008