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Roche (NASDAQ:RHHBY) has announced that its multiple sclerosis (MS) drug ocrelizumab has shown promising results in three separate late-stage trials. MS affects about 400,000 Americans, and million around the world, but treatments are limited due to the mysterious nature of the disease.unnamed (1)

Two studies, OPERA I and OPERA II were carried out in people with relapsing MS, which affects 85 percent of people at the time of diagnosis. It was found that ocrelizumab was superior to interferon beta-1a (Rebif), a well-known MS therapy, which reduces three major markers of disease over a two-year old controlled treatment period. Pharmaceutical company Roche developed the drug, and the data from the trials showed positive results.

“The results of three pivotal trials have the potential to transform the treatment of MS,” said Sandra Horning, Roche’s chief medical officer and global product development.

Though Rebif drug is effective in regular cases of MS, it has been found ineffective against primary progressive sclerosis (PPMS), which affects about 15 percent of MS patients. In comparison, ocrelizumab has been found effective in treating the disease and slowing its progression. Researchers studied 732 patients suffering from the rare, but extremely progressive multiple sclerosis. About 10 percent of patients suffered from side effects.

Results found that the drug provides a 46 percent and 47 percent reduction in relapse rates. The new drug is a humanized monoclonal antibody, allowing to attach to its target more effectively than other competing drugs. Patients saw a 24 percent decrease in disease progression over 12 weeks and a 25 percent decrease over 24 weeks. Globally, the disease affects more than 2.3 million people, making it one of the most widespread diseases. The immune system of affected people begins to attack the protective coverings of nerves, especially the fatty protective layer called myelin.

Roche’s new Ocrelizumab, hailed as new hope for multiple sclerosis has successfully decreased relapse rates in three clinical trials.

Two clinical trials have sought to pinpoint the effects of Ocrelizumab on multiple sclerosis patients, while a third clinical trial targeted specifically patients suffering from primary progressive multiple sclerosis. For this form of the debilitating disease, no treatment is currently approved.

The preliminary results of the third trial show that clinical disability was decreased by approximately one quarter. The other two clinical trials involving treatment of multiple sclerosis patients with Roche’s new Ocrelizumab also yielded encouraging results.

One of the trials cut the annual rate of relapse by 46 percent. The second also saw a drop of the relapse rate by 47 percent.

In calling Roche’s new Ocrelizumab the new hope for multiple sclerosis patients, both the medical community and analysts are comparing the new drug with alternatives already approved and existent on the market.

In comparison with Merck’s Rebif and according to the preliminary results of the Roche studies, Ocrelizumab fares well above the standard. Other drugs and available treatments used in treating multiple sclerosis and particularly the relapsing form of the disease are Sanofi’s Lemtrada and Biogen’s Tysabri, as well as Biogen’s Tecfidera and Novarti’s Gilenya.

However, serious concerns have been raised as per the side effects present with the majority of multiple sclerosis patients. According to chief of neurology Stephen Hauser with the University of California San Francisco School of Medicine and lead researcher on two of the Roche studies, Ocrelizumab proved as safe as standard care interferons.

While the efficiency of Roche’s new Ocrelizumab will be proven in time provided the drug receives approval from U.S. and European regulatory agencies, the company is convinced that the powerful results yielded by the clinical trials are a certain plus.

Roche hasn’t fully disclosed the results of the studies. These were discussed during the European Committee for Treatment and Research in Multiple Sclerosis, taking place on Friday and Saturday in Barcelona, Spain.

More news will follow. However, the Swiss company is set on meeting with the FDA and European regulatory agencies to seek approval for Ocrelizumab in the first quarter of 2016.

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