Recent Articles and News regarding Multiple Sclerosis (contributions from our readers)
Early treatment of MS prevents new symptoms September 14, 1999
NEW YORK, Reuters [HD] via NewsEdge Corporation : Results of a new study add to mounting evidence that treating multiple sclerosis (MS) as soon as possible, before extensive neurological damage occurs, may help delay progression of the disease.
In MS, which strikes more women than men, the myelin sheath -- a material that serves to insulate certain nerves -- deteriorates in the eye, brain and spinal cord. Symptoms vary widely from person to person but may include tingling, dizziness, difficulty walking, tremors, and double vision. Symptoms of the disease may often diminish or disappear, only to return months or years later.
But when Dr. Alasdair J. Coles, of Addenbrooke's Hospital in Cambridge, England, and colleagues treated 29 MS patients with an anti-inflammatory drug called Campath-1H, they found that none of the patients displayed any new symptoms over an 18-month period. But, even though new symptoms were prevented in all participants, about half experienced a worsening of existing symptoms, the researchers report in the September issue of the Annals of Neurology.
Based on magnetic resonance imaging (MRI) brain scans obtained before treatment and throughout the study, the investigators conclude that symptoms were most likely to worsen in people with the most brain inflammation prior to receiving Campath-1H. Symptoms also worsened in people who already had extensive damage to regions of nerve cells called axons, Coles and colleagues report. Axons carry impulses away from the nerve cell.
``For anti-inflammatory drugs to be successful in treating MS, they need to be given early, before axonal death has been established,'' Coles told Reuters Health in an interview.
``Despite its profound effect on the immune system, Campath-1H had very little side effects except that one third of patients experienced Grave's disease, an autoimmune disease of the thyroid gland, that was easily controlled by drugs,'' Coles said. SOURCE: Annals of Neurology 1999;46:296-304. [Copyright 1999, Reuters]
BERLEX STOPS MS BETASERON TRIAL ON ADVICE OF MONITORING BOARD September 15, 1999
BioWorld via NewsEdge Corporation : On the advice of an independent monitoring board, Berlex Laboratories Inc. halted a Phase IV U.S. trial of Betaseron (interferon beta-1b) for secondary- progressive multiple sclerosis (SPMS), but the company can't quite say if that was good news or bad news.
"It's sort of middle-of-the road news," said Wendy Neininger, director of corporate communications at Montville, N.J.-based Berlex.
"When we got the letter from the board, I called up the chairman and asked what it meant," said Jeffrey Latts, vice president of clinical research and development at Berlex. "It's ambiguous. I asked if they were stopping it because the trial was good or bad and he said he wasn't saying. "
Betaseron was approved in 1993 for relapsing-remitting multiple sclerosis. It is partnered with Chiron Corp., of Emeryville, Calif. However, about half of those patients develop SPMS, a more severe and debilitating form of multiple sclerosis.
The companies started a trial testing Betaseron for SPMS in 1996 with a parallel study in Europe. The European trial was stopped early when it showed highly significant benefit. Upon the success of that trial, Berlex and Chiron filed a supplemental new drug application for the indication.
However, the U.S. trial was still under way, with a completion date of March 2000. Some 935 patients were to be enrolled in the three- arm trial.
The monitoring board determined the probability was very small that the primary outcome would change much if preliminary data were released now instead of in March. Therefore, the board recommended that the placebo-controlled study continue until every patient received the final dosage.
As a result of the ruling, clinical investigators will continue to compile data until all patients make their final visits.
In addition, the board recommended that all patients enrolled in the study be given the opportunity to receive Betaseron and will be medically monitored. Berlex is providing Betaseron at no cost to those patients.
"What they're saying is that the best way to preserve the credibility of the final trial is for no one to know its outcome until all the data are compiled. We're about halfway through all the patients having their final visits," Latts said. "I can understand that. I'm curious about the data but we decided to take their advice. But there has been a lot of money spent on this trial and we want it to be as strong as possible."
After the trial is completed and the results unblinded, they will be given at a major scientific meeting by mid-summer, Latts said.
"We've already filed with the FDA, and it is possible that they could act on the European results," he said. "But, more likely, the FDA will wait for our results. We're keeping the door open."
Berlex is a subsidiary of Schering AG, of Frankfurt, Germany. Chiron's stock (NASDAQ:CHIR) gained 3 cents Monday to close at $34.812. n
<<BioWorld -- 09/14/99>> [Copyright 1999, American Health Consultants]
Article Found In Pharmaceutical Development Muscular & Neuromuscular Diseases Central Nervous System Disorders Immunology Biopharmaceuticals Multiple Sclerosis & Demyelination Growth Factors & Cytokines Quick Search
Diagnostic tests for MS September 16, 1999
HOUSTON--(BW HealthWire) via NewsEdge Corporation -- Pathobiotek Diagnostics Inc. (OTC BB: PBTK), a research company engaged in the development of products for the diagnosis of multiple sclerosis (MS) and other immune disorders, Wednesday announced its action to begin the process for filing the Form 10.
The accounting firm, May Swaim and Najvar LLP has been retained to facilitate the process of filing the Form 10. This is the first of three primary entities contracted to help Pathobiotek fulfill the reporting requirements set forth by the SEC.
According to Robert Simpson, CEO of Pathobiotek, "We realize the importance of providing accurate and up to date financial information to our shareholders. This is one of several important steps Pathobiotek will take toward becoming a reporting company."
Pathobiotek will significantly increase marketing efforts for the products introduced this year as well as submit an article for publication in a professional journal in the very near future.
Pathobiotek will continue to focus on development of diagnostic products for applications in the detection and treatment of MS and other immune disorders.
MS drug Avonex propelling Biogen`s growth
September 17, 1999
BOSTON, Reuters [WN] via NewsEdge Corporation : Avonex, an injectable drug used to treat relapsing forms of multiple sclerosis, is proving to be good medicine for its maker Biogen which said on Wednesday it expected higher earnings in the third quarter.
Jim Vincent, head of the Cambridge, Mass.-based biotech company, told investors at a Bear Stearns conference after market close that he expected Biogen to post overall earnings per share of 38 cents, beating Wall Street estimates collected by First Call Corp. by two cents.
Biogen shares climbed more than a point in after-hours trading. Biogen was at 85-1/2 in after hours trading after shedding 3-1/4 point during the day to close at 84-1/8.
About a million people worldwide - including television talk show host Montel Williams, actress Annette Funicello and comedian Richard Pryor - suffer from the debilitating neurological disease.
Biogen said it expected third quarter sales of Avonex to be about $160 million and noted U.S. patient growth was driving the increase.
The number of U.S. patients using the drug was expected to increase by about 5,000 during the third quarter, the company said. Worldwide, the number of Avonex patients is expected to exceed 75,000.
Biogen spokeswoman Kathryn Bloom told Reuters that some 90,000 U.S. patients were taking one of the three Federal Drug Administration-approved MS drugs - the others are Schering AG's Betaseron <SCHG.F> and Copaxone, made by Teva Pharmaceuticals Industries Ltd. <TEVIY.O>.
"We have about 55 percent of the market share in the United States," Bloom said.
Avonex, which is approved for sale in 18 countries around the world, and Betaseron each have about a 40 percent market share in Europe. About 18,000 Europeans are taking Avonex.
"We still see Europe as a strong market opportunity," Bloom said.
Methods for treatment of multiple sclerosis utilizing peptide analogues of human myelin basic protein (Assignee -- Neurocrine Biosciences, Inc.)
September 17, 1999
U.S. Patents via NewsEdge Corporation : Abstract: The present invention is directed toward peptide analogues of human myelin basic protein for use in the treatment of multiple sclerosis. Within one aspect, peptide analogues suitable for treating multiple sclerosis are provided which are at least seven amino acids long and derived from residues 86 to 99 of human myelin basic protein. In addition, such analogues may be altered from the native sequence at positions 87, 88, 97, 98 or 99 to a D-amino acid. Additional alterations may be made at other positions. Pharmaceutical compositions containing these peptide analogues are also provided, as well as methods for treating multiple sclerosis.
Ex Claim Text: A peptide analogue comprising at least seven consecutive amino acids selected from residues 86 to 99 of human myelin basic protein, including residue 97, wherein the L-arginine at position 97 is altered to a D-amino acid, said peptide analogue having increased MHC binding relative to MBP 87-99.
Patent Number: 5948764
Issue Date: 1999 09 07
Immunex Launches Multiple Sclerosis Educational Web Site Immunex MS Knowledge Center Offers Personalized Information Resource For People With Multiple Sclerosis, Their Families and Health Care Providers
September 17, 1999
SEATTLE, Sept. 16 /PRNewswire/ via NewsEdge Corporation -- A new web site, http://www.msknowledge.com, dedicated to educating people affected by multiple sclerosis (MS) was launched today by Immunex Corporation (Nasdaq: IMNX). Developed with input from an advisory board of MS specialists, the multimedia-enhanced site offers comprehensive information on MS, the latest MS news, and feature stories on people living with MS.
The extensive MS Topics section of the site provides in-depth information on a variety of subjects such as "working with your health care team," "dealing with emotional issues" and "managing personal financial matters." Symptom management topics, ranging from bladder and bowel function, to sexuality and skin care are also included.
A special feature of the new Web site will allow patients to tailor the MS Topics section to address issues that are most important to them. By filling out a short Wellness Survey, a personalized Web page will be created that identifies topics that pertain to each patient's needs.
The Profiles of MS section, another unique component of the Web site, features stories of people who are pushing the boundaries of living with MS. The first featured profile is of a modern dancer and choreographer living with MS. Diagnosed in 1987, she has adapted to MS by incorporating the disease into her choreography.
Multiple sclerosis is a chronic, debilitating disease of the central nervous system that, in its various stages, afflicts as many as 350,000 people in the United States. The symptoms of MS result when a breakdown occurs in the myelin sheath, the fatty substance that insulates the nerve fibers of the brain and spinal cord. This demyelination process causes patches of scar tissue, or "sclerosis," which interfere with the nerves' ability to transport messages from the brain to body parts. This can result in a variety of symptoms that range from numbness in the limbs to complete paralysis.