Mandatory Rest Period

MBP8298 moves forward
2007-01-23 14:10:10

The FDA just approved this trial drug for secondary progressive MS to move forward to new phase III trials in the US. I didn't know this drug was an IV drug like Tysabri. This one given every 6 months though. Interesting. " The pivotal phase III clinical trial in the US, named MAESTRO-03 (A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis), will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive)."

- posted by Anonymous @ 9:08 PM - Link @ 9:08 PM - Link to this post - Comments (0)

			Hi, I’m Kim! This site provides a little insight to my journey of being diagnosised with Remitting Relapsing Multiple Sclerosis on October 26th 2004. I review books and documentaries, post MS-related news, and share my photos. Subscribe (RSS) My bloglines Archives Current November 2004 December 2004 January 2005 February 2005 March 2005 April 2005 May 2005 June 2005 July 2005 August 2005 September 2005 October 2005 November 2005 December 2005 January 2006 February 2006 March 2006 April 2006 May 2006 June 2006 July 2006 August 2006 September 2006 October 2006 November 2006 December 2006 January 2007 February 2007 March 2007 April 2007 May 2007 June 2007 July 2007 August 2007 September 2007 October 2007 November 2007 December 2007 January 2008 February 2008 March 2008 April 2008 May 2008 June 2008 July 2008 August 2008 September 2008 October 2008 November 2008 December 2008 January 2009 February 2009 March 2009 April 2009 May 2009 June 2009 July 2009 August 2009 September 2009 October 2009 November 2009 December 2009 January 2010 February 2010 March 2010 May 2010 June 2010 July 2010 September 2010 November 2011

	Tuesday, January 23, 2007 MBP8298 moves forward 2007-01-23 14:10:10 The FDA just approved this trial drug for secondary progressive MS to move forward to new phase III trials in the US. I didn't know this drug was an IV drug like Tysabri. This one given every 6 months though. Interesting. " The pivotal phase III clinical trial in the US, named MAESTRO-03 (A Double-blind, Placebo Controlled Multi-center Study to Evaluate the Efficacy and Safety of MBP8298 in subjects with Secondary Progressive Multiple Sclerosis), will be evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive)." - posted by Anonymous @ 9:08 PM - Link @ 9:08 PM - Link to this post - Comments (0)