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IZVOR:This compound profile was originally published in the June 25 issue of LRLNews, the news publication for employees in Lilly Research Laboratories. Each month, LRLNews profiles a compound in development.]
About Dirucotide: Lilly and Canadian firm BioMS Medical Corp. are collaborating on the development of a potential treatment for multiple sclerosis, also known as MBP8298. Read on to learn about the compound, currently being studied in three late-stage clinical trials.
Multiple Sclerosis Affects More Than 2.5 Million People Worldwide
[Editor's Note: This compound profile was originally published in the June 25 issue of LRLNews, the news publication for employees in Lilly Research Laboratories. Each month, LRLNews profiles a compound in development.]
Description: Dirucotide is a synthetic peptide that consists of 17 amino acids in the same sequence as a portion of human myelin basic protein (MBP). MBP is essential to the process of myelinating nerves, which enables regeneration or repair. In multiple sclerosis (MS) patients, the body's immune system attacks myelin, the protective sheath or coating surrounding nerve fibers in the brain and spinal column. Dirucotide's amino acid sequence duplicates the sequence of the portion of MBP that is believed to be the dominant site of this immune attack.
Dirucotide is administered once every six months by intravenous injection lasting three to five minutes. Early clinical trials indicate that dirucotide significantly delays the progression of MS and eases symptoms in patients with a specific genetic marker, which an estimated 65 to 75 percent of MS patients have.
Lilly licensed dirucotide, also known as MBP8298, from BioMS Medical Corp., a Canadian firm, late last year.
Indications being investigated: Secondary-progressive MS (SPMS) and relapsing-remitting MS (RRMS)
About MS: MS results in damage to the myelin sheath around nerve fibers. As a result, messages between the brain and the rest of the body are disrupted. Although symptoms vary widely, they include blurred vision, loss of balance, numbness or tingling sensations, difficulty walking, and fatigue. Multiple sclerosis is progressive, resulting in increasing disability over time.
According to the Multiple Sclerosis International Federation, MS is one of the most common diseases of the central nervous system. It affects more than 2.5 million people worldwide. Women are twice as likely as men to develop MS. Mean age of MS onset is 29 to 33 years, and most people are diagnosed between the ages of 20 and 50.
While the etiology of MS is not known, scientists postulate that some combination of environmental and genetic factors increases susceptibility to the disease. The prevalence of MS is higher in more northern areas, and, while not directly inherited, MS susceptibility increases if a family member, particularly a parent or sibling, has MS. A viral link to MS also has been proposed.
The Multiple Sclerosis Association of America (MSAA) estimates that 80 percent of people with MS begin with the relapsing-remitting form of the disease, which is characterized by temporary symptom flare-ups. Typically, the flare-ups last for one to three months and are followed by a complete or partial recovery or remission. Many patients go into remission for a year or more between relapses.
MSAA data indicate that more than 90 percent of individuals with untreated relapsing-remitting MS develop secondary-progressive MS within 25 years. This phase of MS involves a progressive worsening of symptoms.
Compound status: Three late-stage clinical trials are under way: MAESTRO-01 (a pivotal Phase II/III trial in Canada and the European Union for SPMS), MAESTRO-03 (a pivotal Phase III trial in the United States for SPMS), and MINDSET-01 (a Phase II trial for RRMS).
Unmet medical need: Current MS drugs are aimed at relapsing-remitting MS and have limited efficacy in secondary-progressive MS.
Potential for patients: Amy Chappell, M.D., medical fellow and dirucotide lead physician, offers a personal perspective on the disease: "As the daughter of an MS patient, I witnessed the devastating effects of disease progression on my mother's quality of life. Although several new MS treatments have been approved in the recent past, they leave much room for improvement in terms of efficacy, tolerability, and, in some cases, safety. Hopefully, dirucotide will address some of the remaining unmet needs of MS patients."
Next steps: Clinical trials for secondary-progressive MS will continue for about two years.
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