Fw: MSFYi - March 2002 Issue

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Subject: MSFYi - March 2002 Issue

MSFYI

Multiple Sclerosis Foundation Internet Newsletter

MSFYi is published monthly by the staff of the Multiple Sclerosis

Foundation for the benefit of MS patients, their families, and caregivers.

We value your opinions!

Please let us know what you think of the MSFYi, this month's features, or

send ideas for future issues.

March 2002

IN THIS ISSUE:

* REBIF® LAUNCHED IN USA

* NEW DEVELOPMENT IN TREATMENT VACCINES FOR

AUTOIMMUNE DISEASES

* THE DRUG DISCOVERY, DEVELOPMENT AND APPROVAL

PROCESS

* INTERNET USE BY DISABLED GROWS

* BERLEX LAUNCHES NEW INTERACTIVE WEB SITE FOR

MULTIPLE SCLEROSIS PATIENTS

* BARRIER FREE EDUCATION

* BRAIN PRODUCES NEW CELLS IN MS

* ENZYME THAT EATS PROTEINS IN THE BRAIN

REBIF® LAUNCHED IN USA

The FDA gave approval on March 8th to Serono Pharmaceuticals to

launch their multiple sclerosis treatment Rebif (interferon beta-1a) in the

U.S. Approval was based on the results of two large multi-center studies

(PRISM, EVIDENCE) in patients with relapsing-remitting multiple sclerosis

(RRMS). The EVIDENCE study was a head-to-head randomized trial that

compared Rebif to Avonex®. The six month results, released in May

2001, indicated that Rebif was superior to Avonex in clinical and MRI

measures. 32% fewer patients experienced a relapse when treated with

Rebif relative to Avonex. The one-year results will be announced in the

American Academy of Neurology meeting in Denver next month.

Rebif was able to gain marketing approval under section 316.3 of the

ODA (Orphan Drug Act) regulations by demonstrating " clinical superiority "

over the other interferon beta-1a product at 24 weeks in the EVIDENCE

study.

It is not known yet when the drug will be actually available for

prescription

in the US market. Rebif has been in use for treatment of

relapsing-remitting MS outside the U.S. for a number of years. For further

details, see Serono's website www.serono.com

The approval of Rebif made another high dose interferon-beta product

available to MS patients in the USA. Betaseron®, a comparable dose

interferon-beta product, has been in use in relapsing-remitting MS in the

USA since 1993. Betaseron was also shown to be superior to Avonex in a

2-year randomized controlled independent Italian study (INCOMIN), using

clinical and MRI measures. Betaseron was significantly more effective in

decreasing the number of relapses, the number of patients who had

increased disability, and the number of lesions on the MRI than Avonex.

The findings from both studies support the view that higher and more

frequent doses of interferon beta therapy are more effective than lower

doses given weekly, in patients with the relapsing-remitting MS. A study is

underway in Europe to evaluate the efficacy of Betaseron in the treatment

of early disease after the first attack.

NEW DEVELOPMENT IN TREATMENT VACCINES FOR

AUTOIMMUNE DISEASES

Data was presented at the SMi " Immune Disorders " conference in

London that demonstrates it may be possible to develop treatment

vaccines for autoimmune diseases.

The Hopkins Medical Institution in Baltimore, MD presented data

from their laboratory that may translate to humans. Peptides based on

L.E.A.P.S. technology (Ligand Epitope Antigen Presentation System, a

novel T-cell modulation platform technology) that alter the immune

responses of an autoimmune inducing antigen, resulted in improved

health in animals.

L.E.A.P.S. based therapeutic vaccines may provide a whole new

approach for the treatment of many autoimmune diseases in man. The

development of vaccines for autoimmune conditions, in particular Type I

Diabetes, Rheumatoid Arthritis and Multiple Sclerosis were identified as

among the highest priorities in the Institutes of Medicine report entitled

" Vaccines for the 21st Century. " Treatment vaccines, which teach the

immune system to control and/or correct its faulty immune responses, are

thought by many to represent the future for the treatment of autoimmune

diseases.

THE DRUG DISCOVERY, DEVELOPMENT AND APPROVAL

PROCESS

Did you know that in the U.S. system of drug approvals it takes an

average of 14.2 years and approximately $500 million for an experimental

drug to travel from the lab to U.S. patients? Once a new compound has

been identified in the lab, new drugs are developed according to the

following schedule:

* Pre-clinical testing - evaluated for safety - 6.2 years

* New Drug Application - reviewed by FDA - 30 days

* Clinical Trials, Phase I - 20 to 100 healthy volunteers to take new drug -

1.5 years

* Clinical Trials, Phase II - 100 to 500 volunteers (people with disease) to

take drug - 2 years

* Clinical Trials, Phase III - 1,000 to 5,000 patients in clinics and

hospitals,

physician monitors - 3 years

* New Drug Application - review by FDA of clinical trials - 6 months

* Approval - FDA approves for physician use to monitor adverse effects -

1.5 years

* Phase IV - additional trials to evaluate long-term effects. - No time

limit

Source : PhRMA New Medicines in Development for Women

INTERNET USE BY DISABLED GROWS

Results of a Poll on Internet usage were released in mid-January.

The poll reports that 35 % of people with mobility impairment, 43 % with

visual impairments, and 39% with cognitive or learning disabilities

regularly

use the Internet at home. The combined percentage averages out to 35%

disabled Internet users, which is five times the 7% who were using the

Internet in 1998.

" If Internet use by persons with disabilities continues at the same growth

rate, it should match the rate (56%) of other (nondisabled) users in a few

years. " Says Gerry Hendershot, Ph. D., senior research advisor for the

National Organization on Disability and the commissioner of the survey.

BERLEX LAUNCHES NEW INTERACTIVE WEB SITE FOR MS

PATIENTS

Berlex Laboratories, the distributor of Betaseron (interferon beta-1b),

unveiled Betaseron.com, a newly designed web site for MS patients, their

caregivers, and healthcare professionals. The site includes in-depth

information about the disease, treatment with Betaseron, and a variety of

important educational and support resources.

The site links to MSPathways.com, a comprehensive, personalized

support program developed by Berlex to help patients deal with the

physical and emotional hardships of MS. MSPathways.com serves as

virtual support by enabling 24-hour access to healthcare professionals.

BARRIER FREE EDUCATION

A web site geared toward disabled students with an interest in science is

barrier-free.arch.gatech.edu. Although some features are directed toward

younger people, many are designed for those considering college or

graduate school.

Click on the " opportunities " link for info on scholarships, internships and

even a few fellowships. There's also info on upcoming workshops and

conferences.

Click on the " access science lab " link for tips on how to make lab

equipment accessible. The recommendations are helpful - like how to

adapt Bunsen burners and where to get easy-to-use test tubes for people

with limited movement of their hands.

Free downloadable computer-simulated biology, chemistry and physics

experiments are available, and there's a graph that shows how to adapt

your computer's functions to perform the experiments, mostly how to set

features like " sticky-fingers " on your MAC or PC. Impress -or gross out-

your children and download the simulated frog dissection.

BRAIN PRODUCES NEW CELLS IN MS

The brain produces new cells to repair the damage from MS for years

after symptoms of the disorder appear, according to a recent study.

However, in most cases the cells are unable to complete the repairs.

These findings suggest that an unknown factor limits the repair process

and may lead to new ways of treating this disorder.

The study was led by the Cleveland Clinic Foundation in Ohio and

supported by the National Institute of Neurological Disorders and Stroke

(NINDS).

In patients with MS, brain inflammation in random patches, or lesions,

leads to destruction of myelin, the fatty covering that insulates nerve

fibers

(axons) in the brain and spinal cord and aids in transmission of signals to

other neurons. This inflammation causes the myelin to deteriorate and

leads to the symptoms of MS. Previous studies have shown that some

brain lesions are repaired during the early years of MS. However, many

other lesions are not repaired.

While the study shows that the brain's attempts to repair itself decrease

over time, new cells were produced even in patients who had had MS for

as long as 15 years, implying that there is a long window of opportunity for

treatment.

Researchers must now determine how long the new oligodendrocytes

(new myelin producing cells) survive in the brain and whether the brain

can produce enough of them to repair all the damage from MS. If the

brain produces enough new cells on its own, then stem cell

transplantation may not be necessary. Research using brain scanning or

other techniques may help to identify patients who are most likely to

benefit from these therapies.

ENZYME THAT EATS PROTEINS IN THE BRAIN

A Florida State University chemist, in collaboration with the Mayo Clinic in

Rochester, MN is studying an unusual brain enzyme that may contribute

to MS, and could one day lead to a treatment.

The enzyme attacks proteins and myelin-sheathed nerve cells in the

brain, which causes them to demyelinate, and seems to block the body's

natural healing process, or ability to remyelinate.

The enzyme, which is a relatively new discovery, is found in animals and

humans. But, because it is difficult to extract from a human spinal cord or

brain for study, the chemist had to recreate the enzyme by finding the

corresponding enzyme in rats, and combine it with human DNA. Insect

cells were used to produce large amounts of the human gene for study.

Having solved the atomic resolution structure (a picture of what it looks

like) of the enzyme by using X-ray crystallography, the researchers will be

better able to design inhibitors that could slow the enzyme's destructive

effects and promote the body's natural healing process.

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**Editor's Note: Material contained in this newsletter is designed to give

you information on various medical conditions, medications, treatments,

and procedures for your personal knowledge and to help you be more

informed on health related issues. It is not intended to be complete or

exhaustive, nor is it a substitute for the advice of your physician. You

should seek medical care promptly for any specific medical problem you or

your family members may have.