Fwd: [MS_Community] new drug

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Reported August 2, 2004

Walk With MS -- Full-Length Doctor's InterviewIn this full-length doctor's interview, Bill Lindsey, M.D., explains a new drug to possibly improve mobility in multiple sclerosis patients. Ivanhoe Broadcast News Transcript with Bill Lindsey, M.D., Neurologist, University of Texas Health Science Center, Houston, Texas, TOPIC: Walk With MS

Explain the background on multiple sclerosis. What is going on in the body?

Dr. Lindsey: Multiple sclerosis is a disease that mainly affects young adults, people in their 20s and 30s. It's an autoimmune attack on myelin, which is the insulation on the nerve cells. The myelin gets disrupted and the nerve signals can't get through. That causes various symptoms such as visual loss, weakness, numbness, and problems with bladder control. The symptoms usually occur in a relapsing and remitting pattern. The patients will get sick, have symptoms for a while, and will then get better for a while.

What does that mean for the quality of life for these patients?

Dr. Lindsey: It varies from person to person. People who have MS vary widely in how severely it affects them. Some people have very few symptoms. They'll have a few exacerbations with transient symptoms and then a good recovery. More commonly, people will have repeated exacerbations and develop permanent symptoms. Often, they end up disabled. Usually, MS doesn't affect their lifespan, but it does affect their ability to work and do their usual activities.

Essentially, it's one of those conditions where the body is wasting away, but the mind stays sharp. Is that correct?

Dr. Lindsey: Any area in the brain or the spinal cord can be affected. Usually, the physical disability, weakness and numbness are much more severe than any cognitive impairment. But people can also have memory problems or cognitive impairment, especially in the more advanced stages.

What does the medication Fampridine-SR do?

Dr. Lindsey: Fampridine-SR, on the molecular level, blocks potassium channels in the axons. What that does is allow nerve signals to get through areas where myelin has been damaged. If there is an area in the spinal cord where there has been an MS attack and the myelin is damaged, but the nerve cells are still intact, this medicine will help the signals from the brain to get through that area and down to the muscles.

So what does that mean for these patients?

Dr. Lindsey: If the drug does what its supposed to do, we're hoping that people will have some improvement in some of their symptoms. The symptoms we're looking at in this study are walking speed and muscle stiffness.

Phase 1 of the study was really for safety and dosing, but were there any empirical results?

Dr. Lindsey: We weren't involved in the phase 1 study. The study they did had placebo controlled patients in it and they chose the doses. They had more doses in the phase 1 study. The doses that we're testing and the measures we're using to see whether the drug works or not, are the ones that looked good in the phase 1 study.

When you say the results looked good, what does that mean?

Dr. Lindsey: They were promising. In the earlier study they had a lot of different outcome measures and tested a lot more things than we're testing now. The walking speed was one of the measures that seemed to respond best to the Fampridine-SR .

What is the goal of this drug?

Dr. Lindsey: The medicines in multiple sclerosis are divided into two classes. The symptomatic medications treat the symptoms and make people more functional. Then, there are the preventive medicines that are trying to treat the actual disease itself and slow it down. Fampridine-SR is a symptomatic medication. It is for somebody who's already been affected by the multiple sclerosis and is using medicines to make them more functional and better able to do their usual activities.

What would this mean if the drug proves effective? What would that mean for the quality of life of MS patients?

Dr. Lindsey: If it works like we hope it will, it will improve their quality of life. If it improves walking speed for people who are using canes or walkers, then they'll be able to get around their house better and do more things throughout the day. If it improves fatigue, which is a main symptom that is very disabling in MS, it will also improve people's ability to do more of the things that they want to do.

How great of an improvement do you foresee this drug being able to make for the patients? Do you foresee these patients being able to throw away their canes?

Dr. Lindsey: We're hoping for a partial improvement in areas where the myelin has been damaged but the nerve cells are still intact. But, what also happens in multiple sclerosis is that the nerve cells themselves get damaged, and this medicine is not going to do anything to help that. I think we'll be able to improve people, but for instance, I don't think that the patient you interviewed yesterday would be able to walk without any type of aid.

Who are the people that this could potentially help and at what stage of their disease?

Dr. Lindsey: This would be a treatment aimed at people who have had MS for a while and have developed some disabilities. The drug is targeting primarily weakness disability, and particularly leg weakness, which is where MS affects first.

Without treatment, what can these patients expect for their future? How debilitating does MS become?

Dr. Lindsey: MS can be very benign or it can be very bad. The typical course for MS includes an initial attack, which is either a worsening of their functioning or a new weakness or numbness. They will then have an attack about once every other year, which will cause them worsen. They have recovery after each attack, but they don't normally recover all the way back to the baseline. Over time, like 10 years or 20 years, they accumulate disability. Many of them end up needing canes or walkers, and many of them end up in wheelchairs.

How many medical centers are involved in this study?

Dr. Lindsey: I think it's around 15 to 20.

How many are you enrolling here?

Dr. Lindsey: We have enrolled three patients here. We had a harder time than expected finding people who fit the entry criteria.

For what reason?

Dr. Lindsey: The study's very specific on walking speed. There are a lot of people that can't walk as fast as they need to, and a lot of people that walk faster than wanted for the study. So, we had a lot of trouble getting people in the criteria.

Is it an experimental drug still?

Dr. Lindsey: It's not approved for anything.

How do you study their walking speed?

Dr. Lindsey: We're looking at a 25-foot timed walk. Basically, we have 25 feet measured out in the hallway. We then take patients out in the hallway and have them walk as fast as they can safely.

This article was reported by Ivanhoe.com, who offers Medical Alerts by e-mail every day of the week. To subscribe, go to: http://www.ivanhoe.com/newsalert/.

END OF INTERVIEW

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