Stem cell from bone marrow may hold hope for multiple sclerosis patients

http://www.newkerala.com/oct.php?action=fullnews&id=6429

London, September 28 : Medical practitioners at the Frenchay hospital, near Bristol, are conducting clinical trials with stem cells drawn from patients' own bone marrow to see whether they can travel to damaged parts of the brain and repair them.

Tens of thousands of patients with multiple sclerosis (MS) may benefit from the treatment if the tests become successful, say the researchers.
The researcher admit that they cannot say in how many months or years their treatment will begin to undo the damage caused by the incurable disease that affects the central nervous system, or whether it would actually work or not.
They, however, are confident that the stem cell therapy will be a major breakthrough for the 85,000 people in the UK who suffer from MS, many of whom are left wheelchair-bound and paralysed.

"We believe that bone marrow cells have the capability to repair precisely the type of damage that we see in the brain and spinal cord in MS. So by giving patients very large numbers of their own bone marrow cells we hope that this will help stabilise the disease and bring about some repair," the Telegraph quoted Neil Scolding, professor of clinical neurosciences for North Bristol NHS Trust, who is leading the trial, as saying.
The trial started six months ago, and it involves six people with MS, aged between 30 and 60.
A pint of bone marrow is extracted from the patients' pelvises, and the process material containing stem cells is injected on the same day into their arms.
The patients will be monitored closely over a period of months, and will be given regular brain scans to see what impact the treatment has had on them.
The Frenchay trial avoids the ethical controversy that surrounds many stem cell studies, as human embryos are not being used in it.
Prof Scolding conceded that though the first patients in the trial underwent the stem cell therapy six months ago, it was yet unknown whether there had been any benefits or whether the MS sufferers would need more than one injection of stem cells.
"I'm hoping there will be some improvement," Liz Allison, an MS patient taking part in the trial, told the BBC.
"We're delighted that this new trial is going ahead and there will be an awful lot of people with MS watching it very closely," said Christine Jones, the chief executive of the MS Trust.

--- ANI

DNA Vaccine Alters Natural Course of Multiple Sclerosis
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Phase 2 results of the investigational drug BHT 3009 (Bayhill Therapeutics, Palo Alto, California), a tolerizing vaccine encoding full-length human myelin ...
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Stem cell from bone marrow may hold hope for multiple sclerosis ...
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Tens of thousands of patients with multiple sclerosis (MS) may benefit from the treatment if the tests become successful, say the researchers. ...
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DNA Vaccine Alters Natural Course of Multiple Sclerosis

Caroline Cassels

http://www.medscape.com/viewarticle/563863

October 5, 2007 — A newly developed DNA vaccine appears to fundamentally alter the disease course of multiple sclerosis in patients with relapsing remitting multiple sclerosis (RRMS).

Phase 2 results of the investigational drug BHT 3009 (Bayhill Therapeutics, Palo Alto, California), a tolerizing vaccine encoding full-length human myelin basic protein (MBP), induced a 50% to 60% reduction in gadolinium-enhancing brain lesions as well as volume reductions in T2 volumes and T1 black holes in MS patients treated with 0.5 mg of the drug, compared with placebo.

Furthermore, the investigators observed statistically significant reductions in several cerebral spinal fluid (CSF) autoantibodies in the BHT 3009 0.5-mg group. The CSF analysis also revealed that the highest impact of BHT 3009 occurred in those with the highest tier of anti-MBP autoantibodies.

"This is a significant step in advancing one of the first antigen-specific therapies for use in the clinic. We're a step closer to providing MS patients with a treatment that fundamentally alters the course of the disease," vaccine inventor Hideki Garren, MD, PhD, from Stanford University, in Palo Alto, California, and Bayhill Therapeutics, told Medscape.

Major Advantages Over Traditional Treatment

Invented by Dr. Garren and 3 other colleagues at Stanford, BHT 3009 offers several advantages over established MS treatments such as beta interferon. Most important, rather than targeting the entire immune system, BHT-3009 targets only disease-causing antigen-specific T-cells that attack the myelin.

In addition, he said, the drug's dosing schedule is only once per month. In contrast, beta interferon treatment protocols range from every other day to once per week. Furthermore, adverse effects, including flulike symptoms, associated with beta interferon can make it difficult to tolerate. In contrast, he said, the tolerability of BHT 3009 is "excellent."

The study will be presented at the American Neurological Association 132nd Annual Meeting on October 9 in Washington, DC and again at the 23rd Congress of the European Committee for Treatment and Research on October 12 in Prague, Czech Republic.

The multicenter randomized, placebo-controlled trial, which was predominantly conducted at more than 40 centers in Eastern Europe, included 289 RRMS patients, the vast majority of whom had never been treated with disease-modifying therapy.

Low-Zone Tolerance

Inclusion criteria included an Expanded Disability Status Scale (EDSS) score of 0 to 3.5. In addition, patients were required to have a minimum of 1 relapse within the year prior to study enrollment and 5 or fewer gadolinium-enhancing brain lesions.

Exclusion criteria were individuals with greater than 5 brain lesions or who had received more than a lifetime total of 180 days of previous disease-modifying therapy.

Study subjects were randomized to 1 of 3 study groups — placebo, 0.5-mg BHT 3009, or 1.5-mg BHT 3009 administered monthly by intramuscular injection for 1 year.

The trial's primary end point was the reduction in the number of gadolinium-enhancing lesions. Secondary end points included various other magnetic resonance imaging (MRI) measures, including gadolinium lesion volume and T2 and T1 black hole volume. Other, non-MRI, secondary end points included relapses and disability.

Results of the study's secondary MRI end points were generally consistent with reductions seen in the primary end point, which was limited to patients in the 0.5-mg group.

"There was no effect with the higher dose of the vaccine. This finding is consistent with the hypothesis that lower doses, given chronically in MS, will tolerize the immune system, a phenomenon known as 'low-zone tolerance.' We did not see any worsening of the disease with the higher dose; there was just no effect," he said.

No Clinical Impact

In addition, the study showed no statistically significant clinical impact of lesion reduction with either dose of the vaccine.

"Unfortunately, we did not see an effect on disability or relapse rates. Although the overall relapse rate was relatively low [compared with trials of other therapies], the study was not sufficiently powered to reveal such an effect. We need another, much larger phase 3 trial to answer this question," said Dr. Garren.

He added plans are currently under way to conduct such a trial, which is expected to launch by the end of 2008.

"In this current trial, we've shown a reduction in lesions and an antigen-specific effect. In the next trial, we want to replicate these results and demonstrate clinical efficacy," he said.

The researchers are also looking at a second, similar experimental agent in type 1 diabetes.

"We have started a safety and proof-of-concept trial using another investigational agent, BHT-3021, in type 1 diabetic patients. We don't have any data to report as of yet, but the initial results are encouraging," he said.

The study was funded by Bayhill Therapeutics Inc. Dr. Garren discloses that he is cofounder of and has received salary, stock, and/or stock options from Bayhill Therapeutics Inc.

American Neurological Association 132nd Annual Meeting: Abstract T84. Presented October 9, 2007.

23rd Congress of the European Committee for the Treatment and Research in Multiple Sclerosis. Presented October 12, 2007.

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