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Rutkove Receives $1m Prize For Biomarker Discovery

Prize4Life Award recognizes ALS biomarker could propel development of new treatments

BOSTON - Seward Rutkove, MD, Chief of the  Division of Neuromuscular Disease at Beth Israel Deaconess Medical Center, has been awarded Prize4Life's ALS Biomarker Challenge for the discovery of a method that could facilitate rapid development of treatments for Amyotrophic Lateral Sclerosis, commonly known as Lou Gehrig's disease.

The $1 million award results for the 2006 challenge issued by the non-profit organization dedicated to accelerating the discovery of a cure for ALS by offering incentives to drive innovation. That challenge was to find a better method for assessing the rate of progression of ALS such that the cost of Phase II clinical trials could be cut in half.

(For a New York Times' story about the discovery and its potential impact, click here.)

Rutkove, an Associate Professor of Neurology at Harvard Medical School, has collaborated with two Northeastern University physicists to develop a new method to measure the health or sickness of a muscle and track its changes over time. Called electrical impedance myography or EIM, the technique is based on the observation that as a muscle becomes more diseased, electrical current moves through it differently. "A tiny alternating electrical current passed through a muscle produces a small voltage that can be measured. As the disease progresses, the muscle atrophies and undergoes changes in its composition," Rutkove explained. "These structural changes produce an increase in the electrical resistance of the muscle."

ALS is a rapidly progressive, invariably fatal neuromuscular disease that affects an estimated 20-30,000 people in the U.S. alone. Most victims die within two-to-five years, and there is no cure. Progress in finding a treatment has been limited in part because researchers have lacked an objective, reproducible, and sensitive way to evaluate how well potential treatments acted against the disease's effect on muscles.

The standard way to evaluate efficacy has been to measure life expectancy but these studies can be long and expensive. This has contributed to the fact that today just one treatment for ALS exists, Riluzole, which extends survival by approximately three months.

"We need new and better treatment for ALS," said Merit Cudkowicz, Professor of Neurology at Harvard Medical School and Co-Chair of the Northeast ALS Consortium. "ALS is a serious neurological disorder characterized by progressive muscle weakness. There have been great advances in understanding the pathways that are affected in people with ALS. While there are hopeful treatment approaches being developed, it is critical to identify technologies that have improved ways to measure the effects of treatment. The new biomarker discovery brings us one step closer to the day when ALS might be slowed, stopped and ultimately prevented."

The practice of measuring electrical impedance has a long history of providing valuable information across a variety of medical and non-medical applications. Rutkove first began research in this area over a decade ago when he began seeking better, non-invasive and more quantitative ways for assessing nerve and muscle disease. He came upon the work the work of two physicists, Carl Shiffman and Ronald Aaron, at Northeastern University, who had been studying the characteristics of electrical current flow through localized areas of muscle. Recognizing the potential value of this concept in the field of neuromuscular disease, he began a collaboration with them in which they studied localized impedance methods in a variety of neuromuscular diseases, including ALS.

Since that time, Rutkove, in collaboration with neurologists at other medical centers which are part of the Northeast ALS Consortium and with funding from the ALS Association and NIH, has obtained additional data using EIM, helping to demonstrate it's effectiveness as a biomarker in ALS. Moreover, recent work in animals has help also helped to prove its potential value and better understand the mechanism of that sensitivity to change in ALS.

The biomarker discovery gives drug developers a highly precise way to measure the effectiveness of experimental therapies earlier, potentially reducing the time and cost of Phase II clinical trials and propelling the availability of new and better treatments for ALS.

"The ALS community has long been searching for a new biomarker for ALS," said Melanie Leitner, PhD, Chief Scientific Officer of Prize4Life. "There are currently no precise measures of ALS disease progression that allow for short-term monitoring of the disease and the assessment of treatment efficacy. Dr. Rutkove's careful and thorough body of work addresses this need, offering renewed hope for the development of new and varied treatment options for the many patients and their families suffering from ALS."

In order to create a handheld EIM device that was specifically designed to measure the health of muscles, Rutkove also began collaborating with Joel Dawson, PhD, a professor in the Department of Electrical Engineering and Computer Science at MIT. That initial work led more recently to Rutkove's helping co-found Convergence Medical Devices so that an EIM device could be created that was specifically optimized for neuromuscular evaluation. Beth Israel Deaconess has filed patents covering the device and the underlying technique. Plans are under way to use CMD's investigational device in a human clinical trial this year.

The company's product is intended to be a portable, hand-held, non-invasive device that a physician or researcher could place over a muscle or group of muscles of interest that provides data which correlates with the health of that muscle. The device would work by delivering an imperceptible current through the muscle. A combination of EIM technology, sophisticated electronics and a highly intelligent algorithm would capture and process more than 1,000 different data points in a single measurement. After approximately 10 seconds, the device would provide the physician or researcher with a score that would reflect the status of the muscle.

The device could measure a variety of muscles - even the tongue - which is important because ALS progression can vary significantly among different muscles. For therapy researchers, the changes in the obtained values would provide reliable, powerful measures of a potential treatment's efficacy. For patients, a physician could follow a patient's numerical score over time to assist in making treatment modifications.

When new and better treatments for ALS exist, the vision is the device may be used to manage ALS treatment, similar to the way blood tests are used to make treatment decisions for diseases like HIV or Lupus today.

"As a practicing neurologist, I regularly witness the devastating effects of ALS," said Rutkove. "I am honored to receive the Prize4Life award and will continue my research to expand the application of EIM to ALS and other neuromuscular diseases."

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and consistently ranks among the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org .