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And then ponder mass murder
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Mass general is the assignee of faustman's patents and mass general wants you dead impaired or ....
Else mass general would see that Bcg is available to all who suffer rot and seek a better lifeperhaps tsarnaev suffered from ms and was simply mad as hell?
Roche said it expects to meet with regulators in the U.S. and Europe in next year’s first quarter to discuss filing applications for approval of the drug. PHOTO: BLOOMBERG NEWS
Roche Holding AG’s Genentech unit said its experimental drug ocrelizumab proved effective in three late-stage studies against multiple sclerosis, potentially heralding an important new treatment option for the debilitating disease.
In two of the studies, which included 1,656 patients with relapsing multiple sclerosis, the most common form of the condition, ocrelizumab proved superior to the commonly used drug, Rebif, in reducing the annual rate of relapse of major symptoms and other measures of the status of the disease, Roche said.
Fewer than 10% of patients had serious side effects on either drug, the company said.
In the third trial, which studied 732 patients with primary progressive multiple sclerosis, the drug was more effective than a placebo in reducing the progression of clinically disabling disease, the company said. The rate of serious adverse events, including serious infections was similar in each group—just over 20%. It marked the first time a drug has shown a benefit in this more serious form of multiple sclerosis in a major trial, researchers said.
Roche hasn’t yet published full results from the studies, which were sponsored by Roche and its Genentech unit. Results will be presented on Friday and Saturday at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis, in Barcelona.
“This is potentially a big deal for our patients,” said Stephen Hauser, chief of neurology at the University of California San Francisco School of Medicine and a leader of the two studies in relapsing multiple sclerosis.
Roche said it expects to meet with regulators in the U.S. and Europe in next year’s first quarter to discuss filing applications for approval of the drug.
Lawrence Steinman, professor of neurology at Stanford University called the findings “a signal advance” for the estimated 15% of patients with the primary progressive form of the disease for whom “so far nothing has worked.”
But for relapsing multiple sclerosis, he said, the ocrelizumab data were in line with some of the 13 other “high efficiency” drugs already on the market. Dr. Steinman, who wasn’t involved with the new studies, said ocrelizumab’s role would likely depend in part on long-term experience with several thousand patients to determine whether the drug is linked to the kind of rare but serious opportunistic infections associated with some of the other medicines.
Multiple sclerosis afflicts more than 250,000 people in the U.S. and more than 2.3 million people world-wide. A result of the body’s own immune system’s attack on myelin sheaths that coat nerve fibers, it typically strikes between the ages of 20 and 40, and affects women more commonly than men. It disrupts transmission of signals between the brain and spinal cord and other parts of the body and is marked by such symptoms as fatigue, muscle weakness, cognitive difficulties and, in some advanced cases, paralysis below the waist.
Many of the other drugs on the market have been especially effective against the relapsing form of the disease, and slowed development of progressive multiple sclerosis, Dr. Hauser said. But even with the new therapies “more than half of our patients 10 years later are worse,” he said.
Currently, because of safety concerns over the more effective treatments, many doctors wait until later in the course of the disease to use them.
Assuming it clears regulatory hurdles, the new drug offers an option of using a “highly effective therapy” early while being “reasonably confident” about its safety, he said.
Ocrelizumab, administered by infusion every six months, targets a protein called CD20 on the surface of immune-system B cells, which Dr. Hauser said trigger an inflammatory process that attacks myelin. His research has played a key role in identifying B cells as a major player in multiple sclerosis, a finding contrary to long-held beliefs about the disease.
Dr. Hauser highlighted one result as especially encouraging for the new drug. While acute relapses typically happen perhaps once a year in the relapsing form of the disease, magnetic resonance imaging studies have shown that bursts of inflammatory attacks on myelin are much more frequent, he said. In the relapsing disease studies, the drug reduced such bursts by 94% and 95% respectively, he said.
“This comes quite close to turning off inflammation” in the myelin sheaths, he said.
Write to Ron Winslow at ron.winslow@wsj.com
