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Archives
Category Archives: MS Treatment
Opexa Therapeutics Reports Year End 2011 Financial Results and Provides Corporate Update
Posted: Published on February 27th, 2012
THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ:OPXA - News), a biotechnology company developing a novel T-cell therapy for multiple sclerosis (MS), today reported financial results for the year ended December 31, 2011 and provided an overview of corporate developments during the last year. 2011 highlights include: Clinical and Regulatory Granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for Tovaxin® for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS); Published the results of the Company’s prior Phase IIb TERMS clinical trial of Tovaxin in a leading peer-reviewed publication, Multiple Sclerosis Journal; Executed strategic agreements with the American Red Cross and the Blood Group Alliance, Inc. to streamline blood procurement for future clinical trials; and Met with Health Canada’s Biologics and Genetics Therapies Directorate as part of the process to secure approval for Opexa to conduct a portion of future clinical development in Canada. Operational Optimized the manufacturing process through the implementation of a functionally closed system and single cycle cGMP process; Advanced overall clinical plans for Tovaxin and clearly defined the study protocol for the planned Phase IIb clinical trial in SPMS; Increased employee headcount thereby strengthening our overall cell therapy expertise in preparation … Continue reading
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Gilenya (Fingolimod): MS Drug Under Health Canada Review in Light of Serious Adverse Events
Posted: Published on February 27th, 2012
OTTAWA, ONTARIO--(Marketwire -02/27/12)- Health Canada is informing Canadians of an ongoing safety review of the multiple sclerosis (MS) drug Gilenya (the brand name for fingolimod). The review was initiated following reports of serious adverse events, including 11 deaths reported internationally. No deaths have been reported in Canada. Gilenya is a prescription drug authorized for the treatment of relapsing-remitting multiple sclerosis to reduce the frequency of attacks (relapses) and delay physical disability. Gilenya is generally recommended when other MS treatments have not been effective or cannot be tolerated. It was authorized in Canada in March 2011. Currently, it is not clear whether the deaths were caused by Gilenya or whether other factors may have played a role. Four of the 11 reports involved serious heart-related events (three involved heart attacks and one involved a disturbance of the heart rhythm), while the other seven are unexplained. Among these seven is a report involving a patient in the United States who died within 24 hours of taking the first dose. At the time of authorization, it was known that Gilenya can be associated with certain types of heart rhythm disturbances. The Canadian labelling contains several important warnings with respect to these risks. At … Continue reading
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Clock ticks toward MS trial application deadline
Posted: Published on February 26th, 2012
Clock ticks toward MS trial application deadline The Canadian Press Date: Friday Feb. 24, 2012 2:49 PM ET REGINA — The clock is ticking toward a midnight deadline for multiple sclerosis patients in Saskatchewan who want to sign up for a clinical trial of a controversial treatment. Health officials say 670 patients have so far applied for the liberation therapy trial in New York state. Saskatchewan will randomly select 86 people to be part of the two-year, double-blind trial. Deb Jordan, a ministry of health spokeswoman, says there are an estimated 3,500 people with MS in Saskatchewan, and the number of applications is in an expected range. Jordan says patients will have to decide if they want to take part in a study where only half will actually receive the treatment. The province has said the first patients can expect to travel to Albany next month. Share with your social Network: The rest is here: Clock ticks toward MS trial application deadline … Continue reading
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War Reporter Died Trying To Retrieve Shoes
Posted: Published on February 26th, 2012
War correspondent Marie Colvin died trying to retrieve her shoes so she could escape an army bombardment in Syria, The Sunday Times has said. The newspaper, which Ms Colvin worked for, has published details of her last hours as hopes to rescue journalists wounded alongside her in the besieged city of Homs have begun to fade. It says Ms Colvin, 56, was with five other journalists when they went into a building housing a rebel press centre in the district of Baba Amr. When they entered they followed the Middle Eastern custom of taking off their shoes and tried to recover them as rockets fell. Ms Colvin was on the ground floor on Wednesday morning when missiles hit the upper floors. The journalists - who included Paul Conroy, a photographer working for The Sunday Times, three French nationals and a Spaniard - were covered in dust but unhurt. They prepared to flee but had to get their shoes first. Ms Colvin ran to the hall, where she had left hers, but when she got there, a rocket landed at the front of the building, a few yards away. The blast killed her and Remi Ochlik, a 28-year-old French photojournalist. Mr … Continue reading
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MS trial in Saskatchewan attracts nearly 700 patients
Posted: Published on February 26th, 2012
Hundreds of Canadian MS patients have gone out of country for a controversial neck vein treatment in recent years. (CBC) Saskatchewan multiple sclerosis patients hoping to take part in a clinical trial of a controversial treatment may soon get a call from the ministry of health. But only around 10 per cent of those who applied will actually get that call. Deb Jordan, a ministry spokeswoman, said 670 people had signed up as of Thursday, just ahead of the Friday midnight deadline for applications to be part of a two-year, double-blind trial of what has been dubbed liberation therapy. Jordan said patient names will be randomly drawn to determine who will fill 86 spots in the test, which will take place in Albany, N.Y. A successful candidate must be a Saskatchewan resident, under the age of 60 and not had liberation treatment. "Once we verify that information, then the applicant will be forwarded to the folks who are involved in the clinical trial," said Jordan. "I want to also emphasize that the fact that a patient may be drawn does not necessarily mean that they will move on to the clinical trial. "There's the medical assessment that has to take … Continue reading
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While there's no MS cure, new drugs have made the feared disease recede
Posted: Published on February 25th, 2012
Zach Nielson, 14, a young MS patient, with the help of a new drug is living a very normal life. Zach, an active boy scout, hangs out at home, Friday, Feb. 17, 2012, in Arvada. (RJ Sangosti, The Denver Post) Zach Nielson at age 11 couldn't quite put his finger on the two words his doctors were avoiding using around him. But his mother certainly could. Deb Nielson knew people in wheelchairs, knew what it meant that Zach was waking up numb, knew how scary it was when he staggered stiffly down the hallway like a young drunk. But just over two years later, a new generation of powerful drugs has drained the power of the words "multiple sclerosis" for Zach and thousands of patients like him. The drugs have erased symptoms and reversed nerve scarring in the largest subgroup of MS sufferers, transforming for the first time victims' experience with the disease. Far from a life sentenced to relentless disability, Zach Nielson is among a growing group who feel as if their MS never happened. "When they first told me, I was worried it would get worse and worse, and I wouldn't be able to have my dream job," … Continue reading
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Judy's MS funding fight
Posted: Published on February 25th, 2012
Select a Publication: N E W S P A P E R S ---------------------------------------------- ---Alberta--- Airdrie - Airdrie Echo Banff - Banff Crag and Canyon Beaumont - Beaumont News Calgary - The Calgary Sun Camrose - Camrose Canadian Canmore - Canmore Leader Central Alberta - County Market Cochrane - Cochrane Times Cold Lake - Cold Lake Sun Crowsnest Pass - Crowsnest Pass Promoter Devon - Dispatch News Drayton - Drayton Valley Western Review Edmonton - Edmonton Examiner Edmonton - The Edmonton Sun Edson - Edson Leader Fairview - Fairview Post Fort McMurray - Fort McMurray Today Fort Saskatchewan - Fort Saskatchewan Record Grande Prairie - Daily Herald Tribune Hanna - Hanna Herald High River - High River Times Hinton - Hinton Parklander Lacombe - Lacombe Globe Leduc - Leduc Representative Lloydminster - Meridian Booster Mayerthorpe - Mayerthorpe Freelancer Nanton - Nanton News Peace Country - Peace Country Sun Peace River - Peace River Record Gazette Pincher Creek - Pincher Creek Echo Sherwood Park - Sherwood Park News Spruce Grove - Spruce Grove Examiner Stony Plain - Stony Plain Reporter Strathmore - Strathmore Standard Vermilion - Vermilion Standard Vulcan - Vulcan Advocate Wetaskiwin - Wetaskiwin Times Whitecourt - Whitecourt Star … Continue reading
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Saskatchewan starts to fill trial spots for controversial MS liberation therapy
Posted: Published on February 25th, 2012
REGINA - Saskatchewan multiple sclerosis patients hoping to take part in a clinical trial of a controversial treatment may soon get a call from the ministry of health. But only around 10 per cent of those who applied will actually get that call. Deb Jordan, a ministry spokeswoman, said 670 people had signed up as of Thursday. The deadline to apply for the two-year, double-blind trial of liberation therapy was midnight Friday. Jordan said names will be randomly drawn starting next week to determine who will fill 86 spots in the test taking place in Albany, N.Y. A successful candidate must be a Saskatchewan resident, under the age of 60 and not had liberation treatment. "Once we verify that information, then the applicant will be forwarded to the folks who are involved in the clinical trial," said Jordan. "I want to also emphasize that the fact that a patient may be drawn does not necessarily mean that they will move on to the clinical trial. "There's the medical assessment that has to take place by the team and it is the ... clinical team that is operating the clinical trial that will ultimately make the decisions about the patients who … Continue reading
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Genzyme Announces EMA Accepts Oral Teriflunomide Marketing Application for Treatment of Multiple Sclerosis
Posted: Published on February 23rd, 2012
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today the European Medicines Agency (EMA) has accepted the filing of the marketing authorization application (MAA) for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS). Acceptance of the MAA starts the EMA’s review process. “The filing represents another important milestone for teriflunomide and brings us one step closer to offering a new treatment option to patients with relapsing MS,” said Bill Sibold, Senior Vice President, Head of Multiple Sclerosis, Genzyme. “As an oral therapy with a promising clinical profile, teriflunomide is extremely well positioned to provide an alternative therapeutic option to patients who are currently taking injectable therapies. Those injectable therapies make up approximately 80 percent of the MS market today.” The purpose of the MAA is to secure approval to market and allow prescription of teriflunomide in the European Union based on data from two completed pivotal Phase III trials, TEMSO and TENERE. These trials represent two of five efficacy studies of teriflunomide in MS that are completed or underway, making the clinical program one of the largest and broadest of any MS therapy in development. An application to market teriflunomide in … Continue reading
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February 15, 2012 National Strategy for CCSVI treatment – Video
Posted: Published on February 23rd, 2012
21-02-2012 11:12 Malcolm speaks in support of a National Strategy for CCSVI Treatment for MS. (Bill C-280) View post: February 15, 2012 National Strategy for CCSVI treatment - Video … Continue reading
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