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To: David Israel-Rosen who wrote (1061)	3/5/2000 1:46:00 AM
From: David Israel-Rosen	Read Replies (2) \| Respond to of 1386

MS EPIDEMIOLOGY - Nationwide, there are an estimated 250,000 to 350,000 people with MS Epidemiology is the study of disease patterns that takes into account variations in geography, demographics, socioeconomic status, genetics, and infectious causes. Epidemiologists contribute to knowledge about MS by studying the relationships between these factors, as well as patterns of migration, that may be related to areas of with high or low rates of MS. There appear to be multiple causes in MS, possibly including viruses and environmental, genetic, and immune system factors. Among the well-established epidemiological observations on MS are: Worldwide, MS occurs with much greater frequency in higher latitudes (above 40ø latitude) away from the equator, than in lower latitudes, closer to the equator. In the U.S., MS occurs more frequently in states that are above the 37th parallel than in states below it. From east to west, the 37th parallel extends from Newport News, VA, to Santa Cruz, CA?running along the northern border of North Carolina to the northern border of Arizona and including most of California. The MS prevalence rate for the region below the 37th parallel is 57 to 78 cases per 100,000 people. The prevalence rate for those above the 37th parallel is 110 to 140 cases per 100,000 people. Nationwide, there are an estimated 250,000 to 350,000 people with MS. An individual who is born in an area with a higher risk of developing MS and moves to an area of lower risk, acquires the risk of the new home if the move occurs before the individual is 15 years old. MS is more common among Caucasians (particularly those of northern European ancestry) than other races, and is almost unheard of in some populations, such as Eskimos. MS is twice as common in women compared to men. Certain outbreaks or clusters of MS have been identified, but their significance is not known. In certain populations, a genetic marker has been linked to MS. A particular genetic trait occurs more frequently in people with MS than in those who do not have the disease. These and other studies have contributed to the opinion that early exposure to an environmental agent might be a triggering factor in people who are predisposed by genetic factors to develop MS. SOURCE: NMSS Information Resource Center and Library. Compendium of Multiple Sclerosis Information (CMSI). Æ 1997, National Multiple Sclerosis Society. Rev. 10/

To: David Israel-Rosen who wrote (1061)	3/5/2000 8:12:00 AM
From: leigh aulper	Respond to of 1386

an eaiser read the competition - REPORT OF RESULTS FROM HEAD-TO-HEAD CLINICAL TRIAL OF COPAXONE October 14, 1999 Summary: A media release describes an unpublished report by researchers at Wayne State University of results from a "head-to-head" comparison of Avonex©, Betaseron©, Copaxone© and non-treatment in relapsing-remitting MS: Although few details are available about the study, the report indicates that in 156 individuals followed for 12 months, those using Betaseron or Copaxone showed a statistically significant reduction in relapse rate, while those using Avonex experienced a reduction in relapse rate that was not statistically significant; Individuals on Betaseron or Copaxone, but not Avonex, showed an "improvement in disability scores" compared to those using no treatment; While a direct comparison of these agents is important in understanding their use for relapsing-remitting MS, the absence of more details about this study and its results makes it difficult to interpret the clinical and scientific significance of these findings. Details: A recent media release describes a report at the annual meeting of the American Neurological Association on October 13, 1999 by Dr. Omar Khan and colleagues at Wayne State University (Detroit, Michigan) on results from a "head-to-head" clinical trial comparing Avonex, Betaseron, Copaxone as well as "no treatment" for individuals with relapsing-remitting multiple sclerosis (MS). While few details of the study or its analysis have been made public, the report indicates that use of Copaxone or Betaseron for 12 months resulted in statistically significant reduction of relapse rate and reduction of disability (measured by the Kurtzke Expanded Disability Status Scale -- EDSS), while Avonex did not show such effects. Because full details about this study and its results have not yet been published or scrutinized, they are difficult to interpret. Information available about this study indicates that 156 individuals with a history of relapsing-remitting MS, and similar age, relapse rate and disability levels, were informed about the available therapies for relapsing-remitting disease and allowed to chose from among them for treatment. Forty chose Avonex, 41 Betaseron, 42 Copaxone and 33 chose to remain untreated. The study was not blinded (participants and examining physicians knew which individuals were using which treatments), and enrollment was not randomized (individuals were free to choose their own treatment). Individuals were followed for 12 months, after which relapse rate during the study and level of disability at its end were determined, and compared to pre-treatment values. Pre-treatment relapse rate was determined by an examination of each individual's relapse history over two years prior to treatment. According to the media release, at the end of 12 months, a statistically significant reduction of relapse rate was found compared to relapse rate at study entry for individuals using Betaseron (from 1.21 relapses per year to 0.61) and Copaxone (from 1.10 relapses per year to 0.63). While a reduction in relapse was seen in individuals treated with Avonex (from 1.20 relapses per year to 0.85), this reduction was not statistically significant. Results for individuals who chose no treatment were not reported. A statistical comparison of relapse rate between the three agents and between any agent and "no treatment" was not reported in the media release. The media release also indicated that there was a statistically significant "improvement in disability scores" in individuals treated with Betaseron and Copaxone, but not with Avonex, compared to those who had chosen no treatment. However, no specific disability data were provided, and details of statistical analysis were not reported. It is impossible to evaluate the true meaning of this result in the absence of such details. This is the first report of a head-to-head clinical study comparing Avonex, Betaseron and Copaxone. The details available at the time of the media release were inadequate to evaluate the specific results. Pivotal clinical trials, of longer duration and involving more study subjects, provided positive data that resulted in FDA approval of each of the three agents. Avonex was approved by the FDA based on results indicating a slowing of progression of disability and reduction of relapse rate in relapsing forms of MS; Betaseron and Copaxone were approved by the FDA based on results indicating reduction in relapse rate in relapsing-remitting MS. A comparison of the currently available treatments for relapsing forms of MS is important to all individuals concerned about appropriate use of disease modifying agents. We look forward to additional information about this reported first study to better evaluate its conclusions. -- Research Programs Department ¸ 1999 The National Multiple Sclerosis Society