Author Topic: Ibudilast receives fast track designation--studied for SPMS and PPMS (MSAA Research News)  (Read 112 times)

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Offline agate

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From the MSAA Research News, April 28, 2016:

Quote
Ibudilast Receives Fast Track Designation

In March, MediciNova, Inc., the biopharmaceutical company developing ibudilast (MN-166), announced that this investigational medication for progressive forms of MS has received fast track designation from the United States Food and Drug Administration (FDA). This designation makes the drug eligible for a quicker review period, possibly leading to an accelerated approval. It is intended for drugs under development for treating serious diseases and with the potential to address unmet medical needs for such diseases.

Once Phase III trial data are available for ibudilast, these may be submitted to the FDA (along with its New Drug Application) and the Fast Track designation would become effective.

Please note that the Phase II trial will not be completed until the end of 2016, so Phase III data needed to submit ibudilast for approval will not be available until a much later time.

Ibudilast is an oral agent with novel immune-modulating and potential neuroprotective properties. It is being studied in both secondary-progressive MS (SPMS) and primary-progressive MS (PPMS).
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SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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From PubMed:

Quote
Contemp Clin Trials. 2016 Sep;50:166-77.

Design, rationale, and baseline characteristics of the randomized double-blind phase II clinical trial of ibudilast in progressive multiple sclerosis

Fox RJ1, Coffey CS2, Cudkowicz ME3, Gleason T4, Goodman A5, Klawiter EC6, Matsuda K7, McGovern M3, Conwit R8, Naismith R9, Ashokkumar A2, Bermel R10, Ecklund D2, Koepp M2, Long J2, Natarajan S10, Ramachandran S10, Skaramagas T10, Thornell B3, Yankey J2, Agius M11, Bashir K12, Cohen B13, Coyle P14, Delgado S15, Dewitt D16, Flores A17, Giesser B18, Goldman M19, Jubelt B20, Lava N21, Lynch S22, Miravalle A23, Moses H24, Ontaneda D10, Perumal J25, Racke M26, Repovic P27, Riley C28, Severson C29, Shinnar S30, Suski V31, Weinstock-Gutman B32, Yadav V33, Zabeti A34.

Author information

1Cleveland Clinic, Neurological Institute, Cleveland, OH, United States. Electronic address: foxr@ccf.org.
2Data Coordinating Center, NeuroNEXT, University of Iowa, Iowa City, IA, United States.
3Clinical Coordinating Center, NeuroNEXT, Harvard Partners, Boston, MA, United States.
4Patient Advocate, Seattle, WA, United States.
5University of Rochester Medical Center, Rochester, NY, United States.
6Massachusetts General Hospital, Boston, MA, United States.
7Medicinova Inc., La Jolla, CA, United States.
8National Institutes of Neurological Disease and Stroke, Bethesda, MD, United States.
9Washington University School of Medicine, St. Louis, MO, United States.
10Cleveland Clinic, Neurological Institute, Cleveland, OH, United States.
11University of California at Davis, Sacramento, CA; currently at Barrows Neurological Institute, Phoenix, AZ, United States.
12University of Alabama at Birmingham, Birmingham, AL, United States.
13Northwestern University, Chicago, IL, United States.
14State University of New York, Stony Brook, NY, United States.
15University of Miami School of Medicine, Miami, FL, United States.
16University of Utah, Salt Lake City, UT, United States.
17University of Texas Southwestern Medical Center, Dallas, TX, United States.
18University of California at Los Angeles, Los Angeles, CA, United States.
19University of Virginia at Charlottesville, Charlottesville, VA, United States.
20State University of New York Upstate Medical University, Syracuse, NY, United States.
21Emory University, Atlanta, GA, United States.
22University of Kansas Medical Center, Kansas City, KS, United States.
23University of Colorado at Denver, Aurora, CO, United States.
24Vanderbilt University, Nashville, TN, United States.
25Weill Cornell Medical College, New York, NY, United States.
26The Ohio State University, Columbus, OH, United States.
27Swedish Medical Center at Seattle, Seattle, WA, United States.
28Columbia University Medical Center, New York, NY, United States.
29Brigham and Women's Hospital, Brookline, MA, United States.
30Montefiore Medical Center, Bronx, NY, United States.
31University of Pittsburgh Medical Center, Pittsburgh, PA, United States.
32State University of New York Buffalo, Buffalo, NY, United States.
33Oregon Health and Science University, Portland, OR, United States.
34University of Cincinnati, Cincinnati, OH, United States.

BACKGROUND:

Primary and secondary progressive multiple sclerosis (MS), collectively called progressive multiple sclerosis (PMS), is characterized by gradual progression of disability. The current anti-inflammatory treatments for MS have little or no efficacy in PMS in the absence of obvious active inflammation. Optimal biomarkers for phase II PMS trials is unknown. Ibudilast is an inhibitor of macrophage migration inhibitor factor and phosphodiesterases-4 and -10 and exhibits possible neuroprotective properties. The goals of SPRINT-MS study are to evaluate the safety and efficacy of ibudilast in PMS and to directly compare several imaging metrics for utility in PMS trials.

METHODS:


SPRINT-MS is a randomized, placebo-controlled, phase II trial of ibudilast in patients with PMS. Eligible subjects were randomized 1:1 to receive either ibudilast (100mg/day) or placebo for 96weeks. Imaging is conducted every 24weeks for whole brain atrophy, magnetization transfer ratio, diffusion tensor imaging, cortical brain atrophy, and retinal nerve fiber layer thickness. Clinical outcomes include neurologic disability and patient reported quality of life. Safety assessments include laboratory testing, electrocardiography, and suicidality screening.

RESULTS:

A total of 331 subjects were enrolled, of which 255 were randomized onto active study treatment. Randomized subjects were 53.7% female and mean age 55.7 (SD 7.3) years. The last subject is projected to complete the study in May 2017.

CONCLUSION:

SPRINT-MS is designed to evaluate the safety and efficacy of ibudilast as a treatment for PMS while simultaneously validating five different imaging biomarkers as outcome metrics for use in future phase II proof-of-concept PMS trials.

https://www.ncbi.nlm.nih.gov/pubmed/27521810
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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AAN2018: Ibudilast slows brain atrophy in trial
« Reply #3 on: April 25, 2018, 03:59:20 pm »
From Multiple Sclerosis News Today (April 19), a brief report on a presentation at the AAN conference currently in session, "#AAN2018: Potential MS therapy ibudilast slows brain atrophy in trial":


https://multiplesclerosisnewstoday.com/2018/04/19/aan2018-ibudilast-slows-brain-atrophy-progressive-multiple-sclerosis-phase-2-trial/?utm_source=Multiple+Sclerosis&utm_campaign=e3d7ca8aab-RSS_US_EMAIL_CAMPAIGN&utm_medium=email&utm_term=0_b5fb7a3dae-e3d7ca8aab-71286581
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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This study, which involved both secondary and primary progressive MS patients, was funded by a large number of major organizations.



Quote
Supported by grants from the National Institute of Neurological Disorders and Stroke (NINDS) (U01NS082329) and the National Multiple Sclerosis Society (RG 4778-A-6) and by MediciNova through a contract with the National Institutes of Health (NIH). The NeuroNEXT Network is supported by the NINDS (Central Coordinating Center, U01NS077179; Data Coordinating Center, U01NS077352; and individual grants to each trial site). Research reported in this article was also supported by grants from the National Center for Advancing Translational Sciences of the NIH to Case Western Reserve University (UL1 TR000439), Columbia University Medical Center (UL1 TR 000040), Montefiore Medical Center (UL1 TR002556), Oregon Health and Science University (UL1TR0002369), University of Cincinnati (UL1 TR001425-03), University of Colorado Denver (KL2 TR001080), Washington University in St. Louis (UL1 TR000448), and Weill Cornell Medical Center (UL1 TR000457).
The link below is to an abstract in the New England Journal of Medicine (August 30, 2018):
https://www.nejm.org/doi/full/10.1056/NEJMoa1803583?query=TOC
« Last Edit: August 30, 2018, 08:57:08 pm by agate »
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

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An article about it in MD (August 29, 2018)--"Ibudilast Explored for Progressive MS in Phase 2 Trial":


https://www.mdmag.com/medical-news/ibudilast-explored-for-progressive-multiple-sclerosis-in-phase-2-trial


MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

  • Administrator
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  • MS diagnosed 1980
  • Location: Pacific Northwest
MS Speaks--online for 12 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

 

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