CMD co-founder receives Prize4Life award for discovery of new ALS biomarker

Convergence Medical Devices (CMD) today announced that its co-founder, Dr. Seward Rutkove, Chief of the Division of Neuromuscular Disease at Beth Israel Deaconess Medical Center and Associate Professor of Neurology at Harvard Medical School, received Prize4Life's prestigious award for the discovery of a new biomarker for ALS (Amyotrophic Lateral Sclerosis), also known as Lou Gehrig's disease. Cambridge, Mass.-based Prize4Life is a non-profit organization dedicated to accelerating the discovery of a cure for ALS by offering incentives to drive innovation. The organization announced its $1 million ALS Biomarker Challenge in 2006 with the goal of finding a biomarker that could reduce the cost of Phase II clinical trials. Dr. Rutkove's research demonstrated the potential to reduce the cost of Phase II trials by 50 percent or more, which could facilitate more rapid development of new and better treatments for ALS.

“As a practicing neurologist, I regularly witness the devastating effects of ALS”

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 for this disease 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. 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 biomarker research has identified a new way to measure how sick a muscle is and track its changes over time: It offers researchers an objective, quantifiable way to measure how well a potential ALS treatment is working to halt disease progression. Called electrical impedance myography or EIM, the prize-winning technique is based on the observation that as a muscle becomes more diseased, electrical current moves through it differently. The practice of measuring electrical impedance has a long history of providing valuable information across a variety of medical and non-medical applications. However, it has never been optimized to measure localized muscle changes associated with neuromuscular disease. 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."

EIM: Proven Technology Specifically Designed for Neuromuscular Disease

Dr. Rutkove co-founded Convergence Medical Devices so that his EIM research, which spans more than a decade and includes over 25 published studies, could inform the creation of a device optimized to measure the health of the muscle. Plans are under way to use CMD's investigational device in human clinical trials to collect device data for further algorithm development, to support a premarket submission to the Food and Drug Administration, and to measure treatment effects as a biomarker along with other endpoints in a Phase II drug trial.

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 to provide data that 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. Once new and better treatments for ALS exist, the vision is that the device could 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 Dr. Rutkove. "I am honored to receive Prize4Life's $1 million ALS Biomarker Prize, and will continue my research to expand the application of EIM to other neuromuscular diseases. It is my greatest hope that someday I could say to patients, 'Great news! Although your muscles deteriorated by 12 percent last year, since you've started this new therapy they've actually gotten three percent better.' Today, as far as ALS is concerned, I can only tell them they are getting worse."

Convergence Medical Devices has formed partnerships with several neuromuscular disease organizations, which plan to use the company's investigational EIM device in future clinical trials. These include agreements with Charley's Fund and the Nash Avery Foundation, two leading organizations which provide research funding to find a cure for Duchenne Muscular Dystrophy (DMD), and the Northeast ALS Consortium, a group of leading physicians dedicated to ALS clinical trials research. The company has also received multiple Small Business Innovation Research grants from both the National Science Foundation and the National Institutes of Health.

Source:

Convergence Medical Devices, Inc.

Comments

  1. Marty Murray Marty Murray United States says:

    ALS is being prevented. Every time a person get's a good night's sleep, that person is preventing ALS. Every time a person chooses to resolve conflict and heal an aspect of the person's life, ALS is being prevented. Every time a person chooses to use a healing approach to deal with a life issue, ALS is being prevented.

    ALS has been slowed. Every time a person diagnosed with ALS makes key changes to the way he or she is operating, the degeneration is slowed.

    ALS has been stopped. Every time a person diagnosed with ALS has made enough changes to the way he or she is operating the degeneration has stopped.

    ALS has been solved. People diagnosed with ALS have succeeded in healing themselves and their lives. They have used common sense approaches that anyone can understand and apply.

    One can see how this is possible by fully examining the situations of people experiencing ALS, as it becomes readily apparent that ALS occurs when readily changeable things in people's lives come together to create it.

    There is no need for people to continue to experience ALS. Ways to slow, stop, prevent and solve it are available now.

    • John A. Gregoire John A. Gregoire United States says:

      Mr. Murray,

      1. Stop calling my wife.

      2. Your assertions are ludicrous at best and, more realistically dangerous and designed to prey upon desperate people who are literally fighting for their lives. To represent that a patient has brought about their own affliction based on repressing emotions is unfair and cruel. If you knew anything about the PALS you would understand that most of us experience an emotional epiphany which results in an entirely new set of life priorities - and a renewal of the human spirit.

      3. Your cyber stalking of PALS and their families to promote your method is the lowest form of snake oil salesmanship 101. IF you have documented cases of cures and/or even evidence of significant symptomatic relief, produce them for the world to see. Lacking that evidence, I suggest you look in the mirror and ask yourself if you are REALLY doing the right thing for others - or just lining your pockets preying on desperate people who need the money for more practical things like food and heat for their homes.

      Please just go away and get a job selling used cars (apologies extended to used car sales people).

  2. Sarah Sarah Germany says:

    Anyone that has ever seen someone with this crippling, muscle wasting disease - that befalls every muscle in your body - shouldn´t give false hope or even say that it can be stopped. One should support these people in every way, to make their remaining life as pleasant - and worthy of living - as possible, which isn´t always easy. Anything else, I believe  is criminal. Many people are being robbed of their remaining time and of their money through false hopes and cures. One should support clinical trials and medical universitys in their effort to find a cure.

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
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