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Accentia agrees with FDA on Revimmune trial.(Brief article)
Florida, USA-based Accentia Biopharmaceuticals says that it met with the Food and Drug Administration for a scheduled pre-Investigational New Drug review of Revimmune, an intravenous form of cyclophosamide. The FDA has indicated its support for Accentia to submit an IND for a pivotal Phase III randomized controlled, multicenter clinical trial of the product, the company's potential therapeutic for refractory, relapsing-remitting multiple sclerosis. The agency indicated that it supports the proposed submission from Accentia and is in overall agreement with the proposed design of the Accentia clinical program.
The Revimmune MS study will enroll subjects in a one-year trial comparing baseline disability to that at month 12 with an interim data analysis. After consultation with the FDA on the design of the trial, ...
- Accentia Biopharmaceuticals Acquires Worldwide Exclusive License to Revimmune...
- Press release article from: Business Wire February 28, 2007 700+ words
Revimmune uses an approved drug in a new patent...indication of multiple sclerosis (MS), Revimmune improves function in most patients and...acquired the exclusive worldwide rights for Revimmune[TM], a patent-pending pharmaceutical...
- Accentia Announces Investigational New Drug Application for Revimmune Usage in...
- Press release article from: Business Wire October 8, 2007 700+ words
...Investigational New Drug (pre-IND) meeting on Revimmune[TM]. The FDA has indicated its support...controlled, multi-center clinical trial of Revimmune, the company's potential therapeutic...of the Accentia clinical program. The Revimmune MS study will enroll subjects in a one...
- Accentia Biopharmaceutical's Revimmune Receives the Frost & Sullivan Multiple...
- Press release article from: Business Wire March 13, 2008 700+ words
...NASDAQ:ABPI) today announced that Revimmune[TM], its potential blockbuster therapeutic...Innovation of the Year Award. If approved, Revimmune would be the first product capable of...primary endpoint for Accentia's planned Revimmune Phase 3 study is the restoration of neurological...
- Accentia Biopharmaceuticals Files Pre-Investigational New Drug (IND)...
- Press release article from: Business Wire July 31, 2007 700+ words
...Food and Drug Administration (FDA) for Revimmune[TM] in the treatment of refractory...function (reversal of disability). Unlike Revimmune, no other approved therapy for MS has...function, the Company believes that Revimmune holds the potential to restore function...
- Accentia Biopharmaceuticals Announces that Revimmune is Profiled in Hopkins...
- Press release article from: Business Wire January 29, 2008 700+ words
...in its Winter 2008 edition profiling Revimmune[TM] as a potential cure for a host...chronicles the history of the development of Revimmune (high-dose cyclophosphamide or HiCy...Hopkins University researchers using Revimmune which show remarkable promise, as well...
- Biovest International Announces that Revimmune is Profiled in Hopkins Medicine...
- Press release article from: Business Wire January 29, 2008 700+ words
...in its Winter 2008 edition profiling Revimmune[TM] for the treatment and prevention...following a bone marrow transplant. Revimmune is a patent-pending pharmaceutical...hemoglobinopathies such as thalassemia. Revimmune can greatly improve the percentage of...
- Accentia Reports on Multiple Sclerosis Study: Revimmune(R) Shows Unprecedented...
- Press release article from: Business Wire June 17, 2008 700+ words
...relapsing-remitting multiple sclerosis with Revimmune[TM], Accentia's patent-pending...delete the autoimmunity. Furthermore, Revimmune is believed to be the first therapy in...Archives of Neurology. It concludes that Revimmune was safe and well-tolerated in patients...
- Biovest Media Alert: Baltimore Sun Reports on First Patient Worldwide to be...
- Press release article from: Business Wire April 11, 2008 700+ words
...written by Stephanie Desmon profiling Revimmune[TM] (high-dose cyclophosphamide...University researchers showing treatment with Revimmune demonstrates remarkable promise for the...transplant made possible by therapy with Revimmune. To access the Revimmune article, please...