AVI BioPharma Opens Investigational New Drug (IND) Application for AVI-4658 in Duchenne Muscular Dystrophy
AVI BioPharma, Inc. /quotes/comstock/15*!avii/quotes/nls/avii (AVII 1.45, -0.09, -5.84%) , a developer of RNA-based therapeutics, today announced that following review by the U.S. Food and Drug Administration the Company's Investigational New Drug (IND) application for AVI-4658 is open. AVI-4658 is AVI's lead drug candidate being developed as a systemically administered treatment for a substantial subgroup of patients with Duchenne muscular dystrophy (DMD), a genetic muscle wasting disease caused by failure to produce dystrophin. AVI plans to initiate a Phase 1b/2 clinical trial in DMD in the U.S. this year.
The intended site for the planned U.S. based study is Nationwide Children's Hospital in Columbus, Ohio, with Jerry R. Mendell, M.D. as the Principal Investigator. The clinical program design is being reviewed in consultation with Dr. Mendell, co-investigator Kevin Flanigan, M.D., and other DMD key opinion leaders. It is anticipated that future clinical evaluation will explore increasing doses of AVI-4658 considering the generally well tolerated nature of the drug candidate as exhibited in the clinical and preclinical studies to date, and the substantial, but variable, increases in dystrophin measurements demonstrated in patients with DMD in the U.K. based Phase 1b/2 clinical trial.
http://www.marketwatch.com/story/avi-biopharma-opens-investigationa...
Replies to This Discussion
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Permalink Reply by cheryl cliff on
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Thank God for this announcement. Just as GSK's delays have beaten us down. Now we watch to see if things actually move forward.
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Permalink Reply by christine good on
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Yes, Thank God!!
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Permalink Reply by Ana Vaish on
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YES !!!!! this is what we needed after what happened with GSK. Now lets see which big pharma joins AVI?????? Go for it AVI.....
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Permalink Reply by arnold on
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Avi IN FACT has received FDA A-P-P-R-O-V-A-L of its IND application for the US dmd human trial
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I confirmed this afternoon that the FDA did approve the US human trial
arnold said:Avi IN FACT has received FDA A-P-P-R-O-V-A-L of its IND application for the US dmd human trial
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Permalink Reply by JoAnne Powell on
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Thank goodness!! This is awesome news!!
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Duchenne Muscular Dystrophy
http://www.antivirals.com/our-programs/rare-diseases/duchenne-muscu...
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Permalink Reply by Ofelia Marin on
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The new website looks good too:
http://www.avibio.com/
http://www.avibio.com/our-programs/rare-diseases/duchenne-muscular-...
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AVI BioPharma, an Oregon-based drug discovery company, expects to partner its lead compound AVI-4658 and may license or sell early-stage drug candidates from its RNA-based platform, according to new CEO David Boyle
The FDA declared this past week the company’s investigational new drug (IND) application for AVI-4658 was open. AVI said it plans to initiate a phase Ib/II trial for AVI-4658, a treatment for the genetic muscle-wasting disease Duchenne muscular dystrophy (DMD), in the US before year’s end. The drug candidate already has completed a phase I trial in Europe.
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Actually AVI is not based in Oregon anymore, it's in WA.
arnold said:AVI BioPharma, an Oregon-based drug discovery company, expects to partner its lead compound AVI-4658 and may license or sell early-stage drug candidates from its RNA-based platform, according to new CEO David Boyle
The FDA declared this past week the company’s investigational new drug (IND) application for AVI-4658 was open. AVI said it plans to initiate a phase Ib/II trial for AVI-4658, a treatment for the genetic muscle-wasting disease Duchenne muscular dystrophy (DMD), in the US before year’s end. The drug candidate already has completed a phase I trial in Europe.
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