Monday, September 08, 2008

BioMS Multiple Sclerosis Drug Gets FDA Fast Track - Human stem cells help mice in MS research

BioMS Multiple Sclerosis Drug Gets FDA Fast Track
From Reuters Health - Sep 04, 2008
OTTAWA (Reuters) - Canadian biotechnology company BioMS Medical Corp said on Thursday its lead drug for the treatment of multiple sclerosis was granted fast-track designation from the U.S. Food and Drug Administration.
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BioMS Multiple Sclerosis Drug Gets FDA Fast Track

Reuters Health - Sep. 04, 2008

OTTAWA (Reuters) - Canadian biotechnology company BioMS Medical Corp said on Thursday its lead drug for the treatment of multiple sclerosis was granted fast-track designation from the U.S. Food and Drug Administration.

Fast-track designation could help development and speed the review process of dirucotide, for the treatment of secondary progressive MS, now being evaluated in a U.S. Phase 3 trial.

The designation is reserved for products intended to treat serious or life-threatening conditions with the potential to address unmet medical needs. Multiple sclerosis is caused by an immune attack against normal components of the central nervous system.

About 510 patients have been recruited for the company's U.S. trial at 68 sites and will receive either dirucotide (MBP8298) or a placebo intravenously every six months for two years.

BioMS signed a licensing and development deal with Eli Lilly in December for dirucotide, sending its shares 50 percent higher.

The arrangement gives Lilly worldwide rights to dirucotide and BioMS an upfront payment of $87 million with potential milestone payments of up to $410 million and escalating royalties on sales if the drug is approved.

The companies said they would collaborate on development of dirucotide, with Lilly responsible for future research and development, manufacturing and marketing.

BioMS Chief Executive Kevin Giese told Reuters that it hoped for approval of the compound in Canada and Europe by 2011 and in the United States by 2012.

Shares in BioMS closed at C$3.21 on the Toronto Stock Exchange on Wednesday. So far this year, the stock has dropped about 19 percent. ($1=$1.06 Canadian)

(Reporting by Susan Taylor, Editing by Frank McGurty)

Copyright © 2006 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.

Second Opinion: Botox can have uses beyond the cosmetic

The Sacramento Bee Sun, 07 Sep 2008 0:10 AM PDT
My health plan denied Botox injections for me, which were recommended by my neurologist in order to relieve severe muscle spasticity caused by multiple sclerosis.


Natural Substance Knock Offs in the FDA Pipeline Could be Dangerous
Food Consumer - Lisle,IL,USA
Pipex Therapeutics is seeking approval for something called Trimesta. This is just a knock off of natural estriol, the very same substance that the FDA has ...


MediciNova to Present At Merriman Curhan Ford's 5th Annual ...
MarketWatch - USA
... assets in its development pipeline: MN-221 for the treatment of acute exacerbations of asthma and MN-166 for the treatment of multiple sclerosis. ...
Update on Relapsing-Remitting MS: B-cell Depletion with Rituximab

IIn this article review, Dr. Bruce Cree comments on a recent clinical trial that explored the use of rituximab, a monoclonal antibody directed against CD20+ B lymphocytes, as therapy for patients with multiple sclerosis.
Projects In Knowledge [more]
Potential Mechanisms of the Human Polyomavirus JC in Neural ...

RedOrbit - Dallas,TX,USA
In addition to its occurrence as an AIDS- associated disorder, PML was also recently observed in patients with multiple sclerosis undergoing integrin ...

Diagnosis and Types of MS

Dr. Grand'Maison
MS Clinic Director – Neuro Rive-Sud
Greenfield Park, QC
View BIO

Q :

I would like to know if the terms "lesion load," "disease burden" and "lesion volume" are interchangeable.

A :

“Lesion load", "disease burden" and "lesion volume" are often used interchangeably. They usually refer to the total volume of T2 lesions on an MRI scan. Accurate measurements of lesion volume are complex and time-consuming and are unfortunately not performed for clinical purposes, only for research purposes. Clinically, radiologists report on the number, size and localization of lesions as well as whether they meet Barkhoff's criteria for dissemination in space or in time.
9/8/2008 8:05:59 PM
More answers from Dr. François Grand'Maison
More answers in the category: Diagnosis and Types of MS

DISCLAIMER: Please be aware that this information does not necessarily represent the opinion of the MS Society of Canada, and is not intended as medical advice. For specific advice and opinion, always consult a physician.
© 2008 Multiple Sclerosis Society of Canada |

Pot-candy owner sentenced on federal drug charges

Martin said he joined the medical marijuana movement after seeing his father die painfully of prostate cancer in 2002 after a 10-year battle. His father

Dear Bill,

We Need YOUR Support To Help People Living With MS

There are only 3 days left to reach our online membership goal by September 10th.

Make your 2008-2009 Member Drive gift today.

As long as multiple sclerosis exists, we have to work even harder to keep people moving. Can you please help?

There are just three days left to reach our 1,500 online member goal before September 10th — click here to make your 2008-2009 Member Drive gift today.

As a 2008-2009 member, you will help us:

  • Fulfill our promise to achieve $35 million in research funding — the Promise: 2010 Campaign targets under-explored areas of promise, including a groundbreaking partnership to help children with MS.
  • Break down barriers to critical government programs — like Medicare, Social Security Disability, and Veterans Affairs Benefits — and drive support for disability rights that keep people with MS moving forward.
  • Invest in technology and tools to deliver programs and services to more people affected by MS, regardless of where they live.

Over 400,000 Americans live with the challenge of MS each day. And every hour, every day, someone else hears the words “you have multiple sclerosis.” Here at the National MS Society, we are doing everything in our power to find the cause and cure for MS.

Our continued success depends on the generous support of people like you — so don’t wait, make your 2008-2009 Member Drive gift today.

With your continued support, we are doing everything in our power to find the causes and cures for MS.


Weyman T. Johnson
Chairman, National MS Society Board of Directors
Diagnosed in 1990

P.S. If you’ve already sent your 2008-2009 Member Drive gift, thank you.

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Early and ongoing treatment with an FDA-approved therapy can make a difference for people with multiple sclerosis. Learn about your options by talking to your health care professional and contacting the National MS Society at or 1-800-344-4867.
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stem cells

Trio wants Lions Club to back stem cell research
The Patriot-News - - Harrisburg,PA,USA
... about stem cell research. It started when Ted Anspach, a member of the Lions Club, went to Johns Hopkins for treatment for his multiple sclerosis. ...

The Patriot-News - - Harrisburg,PA,USA
Ted Anspach, who is being treated at Johns Hopkins for multiple sclerosis, is also lobbying the Lions to back stem cell research. Anspach said he is working ...

Human stem cells help mice in MS research
Jerusalem Post - Israel
... Human embryonic stem cells injected by Hadassah University Medical Center scientists in the brains of mice with an animal model of multiple sclerosis ...

More positive data for GW Pharma's Sativex
Pharma Times (subscription) - London,UK
... of its cannabis-based product Sativex which confirm the long-term efficacy of the drug in patients with neuropathic pain due to multiple sclerosis. ...

Teacher refuses to allow his illness to win
Charleston Daily Mail Mon, 08 Sep 2008 7:21 AM PDT
SOUTH CHARLESTON, W.Va. -- Two years ago, when things were especially difficult for Roger Samples - hfe was missing more school, having more episodes - a doctor told him to stop teaching. The teacher had multiple sclerosis, and the disorder was winning.Sam...

Rising bills for new drugs are changing health insurance
Macon Telegraph Mon, 08 Sep 2008 0:12 AM PDT
Sally Garcia, a 53-year-old lawyer disabled by multiple sclerosis, was torn

Tuition-free medical school deluged with applicants
By Anne Zieger

At Harvard Medical School, there were 40.2 applicants for every open slot. At Yale University School of Medicine, faculty members accepted one student in 50.2, and Duke University School of Medicine admitted one in 53 prospective students. Then, there's the University of Central Florida College of Medicine. For its first class, it got 67.5 applicants for every open slot.

So, why is an as-yet unknown medical school in central Florida attracting such attention from first-rate students with high GPAs and MCAT scores yet? Actually, there are 160,000 reasons. UCF is taking the unprecedented step of offering accepted students $40,000 per year for four years to the 40 students admitted to its program. As of early September, the school had received more than 2,700 applicants for those 40 slots, small wonder given that most prospective doctors will graduate with average debt levels of about $140,000.

The scholarship was spearheaded by Dr. Deborah German, UCF College of Medicine's dean. Dr. German, who received a full scholarship to Harvard, wanted other students to have the advantage she had, so she fought to build a fund that could cover all incomings. After a long period of relentless fundraising, Dr. German pulled together $7 million in scholarship funds. Students will receive $20,000 per year for tuition and $20,000 for personal expenses.
To learn more about UCF's scholarship program:
- read this AMNews piece,11tej,osy,lsix,2ts6,5ewk,1y5l

The science of happiness

By Marnell Jameson

Being happy has always seemed like a good idea. But now science, with research to back it up, can finally show us how to get there. >>


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