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Saturday, January 31, 2009

BioMS drug (dirucotide) fails mid-stage study

Fri Jan 30, 2009

TORONTO, Jan 30 (Reuters) - BioMS Medical Corp on Friday said its lead drug for the treatment of multiple sclerosis failed to meet a main goal in a mid-stage study , sending the company's shares down more than 50 percent.

The small biotech said the study showed the drug did not prevent symptoms from coming back. People who took the drug were just as likely to have symptoms return after 15 months as patients who did not take it.

"We have long believed that the outcome of this study would be very uncertain, given that this trial was statistically underpowered and that the compound was not previously tested on humans for this indication," Maher Yaghi, an analyst at Desjardins Securities in Montreal, said in a research note.

The drug, which was being tested in patients with relapsing-remitting multiple sclerosis (RRMS) did, however, show signs of slowing down the progression of the crippling disease.

"The results are more positive than negative," said Douglas Loe, an analyst at Versant Partners. "The aspects by which the drug did perform well in this trial are those that which are germane to performance in its pivotal secondary progressive MS trial, which is a separate clinical program."

Loe said that program is seen as key to partner Eli Lilly (LLY.N), which signed a licensing and development deal with BioMS in 2007.

Multiple sclerosis, a condition in which the body's immune system attacks the protective cover of the nerves, is one of the leading causes of neurological disability in young adults.

BioMS said it will continue to analyze the results of the mid-stage trial.

Dirucotide is also being studied in two late-stage trials -- in the United States and across Europe and Canada -- as a treatment for secondary progressive multiple sclerosis (SPMS).

This, Yaghi said, is where the company might find more success.

"The firm may benefit from the drug's potential in SPMS, given that the Phase III studies in this indication are more powered to detect significance (vs the RRMS study) and, in our view, have higher odds of success."

The drug had received fast-track status from U.S. health regulators for the SPMS indication last September, a designation that is reserved for products intended to treat serious or life-threatening conditions with the potential to address unmet medical needs.

BioMS President and Chief Executive Kevin Giese shrugged off the stock performance on Friday.

"I think it is probably knee-jerk. People need to look at the data and see what it really says," Giese said. "Often, when people see the top headline that we failed to meet the primary end-point, they react to that without looking at what we were able to say.

Giese said the company and Lilly will continue to analyze the results of the trial, noting it should not affect its timetable for another trial in the second half of 2009, with an eye for approval in 2011 or 2012.

(Reporting by Scott Anderson, additional reporting by Vidya L Nathan in Bangalore; editing by Rob Wilson).

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Friday, January 30, 2009

John Hopkins Project Restore

Information provided by Kirstie in Miami

The people behind Project RESTORE - patients and their loved ones, physicians and researchers, board members and volunteers - believe that we are at the brink of a medical revolution in the diagnosis, treatment and ability to cure multiple sclerosis, transverse myelitis and other neuroimmunological disorders. Watch and read more>>


If you have questions about this research, please call 410.614.6651

June 20, 2006 -- In a dramatic display of stem cells’ potential for healing, a team of Johns Hopkins scientists reports that they’ve engineered new, completed, fully-working motor neuron circuits -- neurons stretching from spinal cord to target muscles -- in paralyzed adult animals.

» Read More

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Finding an MS Center Near You

The Information found here, is available at the National MS Society's Website:

Click this link to find the corresponding State (in the USA ) to find the clinical facilities that have collaborative agreements with the National MS Society. Each appropriate chapter clinical advisory committee, composed of MS experts, periodically reviews and approves the affiliations.

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A Reader's comment on where to save on cost of Rx Medications

Dear Friends & Family:

If You Use A lot of prescription drugs you can see that having your prescription medications filled at

Costco Pharmacy should definitely save you a lot of money.

I actually experienced this price difference last year.

I know I have mentioned this fact to many of You that anyone can have prescriptions filled at

the Costco Pharmacy without having a membership to the store but once you are in the store you cannot

buy anything from the rest of the store but only pharmacy items without a Costco membership.

God bless you,

David Lane

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Stem cell transplants show promise for MS: U.S. study

Source: Reuters News
Thu Jan 29, 2009 6:47pm EST

By Julie Steenhuysen

CHICAGO (Reuters) - U.S. researchers have reversed multiple sclerosis symptoms in early stage patients by using bone marrow stem cell transplants to reset the immune system, they said on Thursday.

Some 81 percent of patients in the early phase study showed signs of improvement with the treatment, which used chemotherapy to destroy the immune system, and injections of the patient's bone marrow cells taken beforehand to rebuild it.

"We just start over with new cells from the stem cells," said Dr. Richard Burt of Northwestern University in Chicago, whose study appears in the journal Lancet Neurology.

» Read More

Sorry, but it appears that the article shown above, was removed from the website that I was linking it to...

Now just posted another article (of the same subject), that you can link-to-instead, by clicking here. sorry again for any inconvenience this caused.


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Wednesday, January 28, 2009

First Clinical Study on Ultra-High-Field MR Imaging in Patients with Multiple Sclerosis: Comparison of 1.5T and 7T

January 2009
Kollia K, Maderwald S, Putzki N, Schlamann M, Theysohn JM, Kraff O, Ladd ME, Forsting M, Wanke I.

Department of Diagnostic and Interventional Radiology and Neuroradiology and Department of Neurology, University Hospital Essen, Essen, Germany; and Erwin L. Hahn Institute for Magnetic Resonance Imaging, University Duisburg-Essen, Essen, Germany.

Summary: This study compared conventional strength MRI to scans which used a much more powerful magnet in people with MS. It was found that the latter technique was more precise in detecting and defining brain

» Read More

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MS Related - Questions and Answers / Guides and Webcasts

SOURCE: The National MS Society - http://www.nmss.org

Leaving Comments, Suggestions and/or Questions, are Always Appreciated. - Thank you

Questions, for those newly Diagnosed with MS

If you or someone close to you has recently been given a diagnosis of multiple sclerosis, you probably have a lot of questions and concerns. Or, you may be feeling so overwhelmed by the diagnosis that you aren’t sure what kinds of questions to ask. The National MS Society has developed programs to give you the information and support you need to live comfortably and confidently with this change in your life.

Taking the First Steps

Worried about the COST of your MS Therapy?

Coping with MS is challenging enough without having to worry about the cost of your MS therapy. MS LifeLines Access Made Simple is a program that can help you get affordable access to Rebif...regardless of your financial status* (subject to meeting eligibility requirements).
* The MS LifeLines Access Made Simple program is subject to change or discontinuation at any time.

Tuesday, January 27, 2009

An MSIF interview of Stuart Schlossman

The January 2007 MSIF interview of Stuart Schlossman

Can be found when clicking here .

A terrible photo though. Too bad they cannot change it



Cladribine Trial Results, Multiple Sclerosis

Article Date: 26 Jan 2009

Cladribine, an experimental oral drug for relapsing MS is effective in reducing the number of relapses experienced according to new research reported today.

The trial, called CLARITY, was a two year study involving 1,326 people with relapsing/remitting MS receiving one of two doses of cladribine or an inactive placebo.

During the study, people receiving the lower dose of cladribine experienced a 58% reduction in relapse rates compared to the placebo group (an average of 0.14 relapses compared to 0.33). Side effects included lymphopenia, a reduction in white blood cells, headaches and nasopharyngitis (a cold).

Detailed results from the study will be presented at a conferences in 2009 and the manufacturers, Merck Serono, hope to submit the drug for licensing during the year. The National Institute for Health and Clinical Excellence (NICE) have already suggested that they may include cladribine in their next round of assessments.

Pam Macfarlane, Chief Executive of the MS Trust said, "We welcome the positive results of the study. We look forward to the fuller results which we hope will give a clearer picture of the effectiveness of this drug for people with MS."

source: Medical News Today

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Merck’s Multiple Sclerosis Pill Prevents Relapses

By Naomi Kresge

Jan. 23 (Bloomberg) -- Merck KGaA, the German drugmaker seeking to be first with an oral medicine for multiple sclerosis, said its experimental pill cladribine prevented flare-ups of the debilitating neurological disease in a study.

Patients who took the pill suffered 55 to 58 percent fewer relapses, depending on the dose, than those who took a placebo during the two-year study, the Darmstadt, Germany-based company said today.

The German drugmaker said it is on track to submit an application for approval to European and U.S. regulators by the middle of this year. Merck shares climbed 5.53 euros, or 8.6 percent, to 69.89 euros in Frankfurt.

Cladribine tablets are among several oral medications for multiple sclerosis now in the final stage of clinical testing. Used to treat leukemia since the 1990s, the drug reduces the number of lymphocytes, white blood cells believed to be linked to multiple sclerosis, a disease in which the body’s immune system attacks the central nervous system. Side effects of headaches and cold symptoms were comparable in the dummy pill and cladribine patient groups, Merck said today.

Merck and Swiss drugmaker Novartis AG have said they will ask regulators in the U.S. and Europe this year to approve pills to treat the disease. Novartis released preliminary results last month showing its pill, known as fingolimod, cut relapse rates as much as 52 percent more than a standard therapy.

Side Effects

Merck already makes Rebif, one of the three beta interferons now commonly prescribed for multiple sclerosis. The injected drug, which will begin to lose patent protection in 2012, had 1.22 billion euros ($1.68 billion) in sales in 2007.

Patient advocates will be watching the long-term side effects of cladribine, which was given over a shorter time period to leukemia patients than it likely will be to multiple sclerosis sufferers, said Dr. Doug Brown, research manager for the Multiple Sclerosis Society in London, before today’s results were released. Brown said they will also want to see whether the oral medicines slow progression of the disease.

Merck and Novartis have said they will present full clinical trial results for their experimental pills at medical conferences later this year. Merck said the new study, which it funded, followed about 1,300 patients.

To contact the reporter on this story: Naomi Kresge in Zurich at nkresge@bloomberg.net

Last Updated: January 23, 2009 11:48 EST

source: Bloomberg.com

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The Drama of Multiple Sclerosis Drug Companies

source: about.com
Monday January 26, 2009

Drug companies that attempt to create and test new multiple sclerosis medications seem subject to a lot of drama these days. There seems to be a squeeze on available money and that is making investors nervous. Those investors, in turn, are trying to force companies to partner and be bought out. Here's one story:

Avigen Inc., a company which was developing a drug to control muscle spasticity in multiple sclerosis had to fire around 70% of its employees when its drug failed to pass a clinical trial. Now, the company's number one shareholder (a venture capital fund called Biotechnology Value Fund or BVF) is trying to force a change in leadership at the company and a merger with another company called MediciNova Inc. MediciNova is also working on a multiple scerlosis drug (read the full press release).

I feel bad for all the researchers and patients who get caught up in the business side of things. I'm not naive and I know that developing new treatments and medications costs money and relies on businesses that are willing to take risks and invest in new medical technologies. But it just seems that recently there have been a lot of decisions made for business reasons and I'm just afraid that researchers who could be making progress are having to struggle to keep their jobs. It's a shame.

This article was written By Julie Stachowiak, Ph.D., About.com Guide to Multiple Sclerosis

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