A board to discuss future MS therapies in early stage (Phase I or II) trials.


Postby dignan » Mon Jan 09, 2006 10:14 am

Here's a drug (Sanofi-aventis' HP184) in the early stages that might be helpful for MS and other conditions.

Tireless quest for a cure, Lorenzo-style

Globe & Mail - January 9, 2006...

Of particular interest is a drug called HP184, a sodium and potassium channel blocker that has been tested on spinal cord patients. When Jacob's parents brought the drug, made by Sanofi-aventis, to the attention of doctors, none had heard of it.

"They're very proactive, they were actually the ones who first told me about HP184, I didn't know about it until then," Jim Garbern, associate professor of neurology at Wayne State University School of Medicine, said in a telephone interview from Detroit.

But when Dr. Garbern, who specializes in PMD, heard about it, he immediately started to think of it as a potential treatment for PMD and more common diseases, such as multiple sclerosis.

Dr. Garbern said he is currently in talks with Sanofi-aventis to see if HP184 might help compensate for abnormalities in myelin.

"If animal studies are successful, the hope would be, we could know within a year," Dr. Garbern said. "And then we could probably pretty rapidly start testing it in human patients."

Jacob's parents want their son to be part of the research trial, provided the drug is safe. They would also like to obtain the drug, at some later time, under Health Canada's special access program.

Under that program, patients can, in some circumstances, get access to drugs before they have been licensed for approval.

"Although it is unusual to receive requests for products that are in earlier stages of development (pre-phase III) we will consider such requests if there is a good clinical rationale, data available to support the proposed use and no other regulatory option to provide access," Health Canada spokeswoman Jirina Vlk said.

Through a group called Jacob's Ladder, part of the Canadian Foundation for Control of Neurodegenerative Disease, they are trying to raise $100,000 (U.S.) -- the estimated cost to run the clinical trial on HP184. That amount will cover the testing on animals and help kick-start the study on patients afterward.

Today, Jacob attends Zareinu Educational Centre of Metropolitan Toronto, a Hebrew day school for children with special needs, located in Thornhill, north of Toronto.

There, he learns how to use a special switch, so he can communicate with others.

"If he doesn't get these tools, he's dependent on adults to read his mind," said Barbara Nash Fenton, his speech language pathologist at Zareinu. "I'm setting up an alerting device for him to say 'I need help.' "

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Postby bromley » Mon Jan 09, 2006 10:25 am

The UK MS society is focusing on the issue of sodium and potassium channel blockers and are trialling one drug.

'MS Frontiers 2005 - Trials of neuroprotection in MS: present and future
Dr Raj Kapoor from The National Hospital for Neurology and Neurosurgery, London, focused on clinical trials of neuroprotection in MS.

Until recently, it was thought that disability in MS was caused mainly by the gradual loss of the fatty insulating layer of myelin which surrounds nerve fibres (axons), and which allows them to conduct electrical signals. However, we now know that most of the permanent disability in MS occurs because the axons themselves degenerate.

Experience suggests that the current strategy of modifying the immune system may not be able by itself to prevent this axonal degeneration and consequent disability, and that we will need to develop a second strategy, called neuroprotection, to achieve this goal. In order to do so, we will need to identify and to inhibit the mechanisms by which axons are damaged.

Research work has already identified several such mechanisms. For example, our group has shown that axons may be flooded with toxic levels of sodium from the surrounding tissue fluid as a result of inflammation in MS, and that the resulting damage can be prevented by drugs which reduce the entry of sodium. As a result, we have been awarded a grant by the Multiple Sclerosis Society to carry out a clinical trial to test the neuroprotective effects of one of these sodium channel blocking drug, lamotrigine, in people with the secondary progressive form of MS. We will randomize people in the trial to receive treatment either with lamotrigine or with an identical placebo (i.e. dummy) tablet for two years.

We will be able to compare the effect, of lamotrigine with the placebo, on the gradual shrinkage of the brain caused by axonal degeneration. This will be done by carrying out MRI scans at regular intervals. We will also measure the actual levels of disability in the two groups to assess the extent to which the treatment slows down its progression. This is likely to be the first of a number of trials which seek to block axonal degeneration by inhibiting the mechanisms by which the axons are damaged, and which offer new hope of treatments which can prevent people with MS from becoming disabled'.
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