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Athersys, Inc. Message Board

  • toegar2000 toegar2000 Dec 1, 2013 9:49 AM Flag

    Athx info on Multistem

    A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
    This study is currently recruiting participants.
    Verified November 2013 by Pfizer
    Sponsor:
    Pfizer
    Collaborator:
    Athersys, Inc
    Information provided by (Responsible Party):
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT01240915
    First received: November 10, 2010
    Last updated: November 15, 2013
    Last verified: November 2013
    History of Changes

    Full Text View
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    No Study Results Posted
    Disclaimer
    How to Read a Study Record

    Purpose

    MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources. Factors expressed by MultiStem cells are believed to reduce inflammation and regulate immune system function, protect damaged or injured cells and tissue, promote formation of new blood vessels, and augment tissue repair and healing. MultiStem cell treatment resulted in significant efficacy in a mouse model of Graft versus Host Disease with almost complete reversal of gastrointestinal pathology (similar to pathology that would be expected in Ulcerative Colitis). These data, together with safety data generated in 2 other clinical trials, suggest that MultiStem has the potential to be a new treatment option for patients with ulcerative colitis. This is the first study of MultiStem in this patient population and will cautiously explore the safety/toleration and potential benefit of this new treatment in patients with moderate to severe disease.

    Condition Intervention Phase
    Colitis, Ulcerative
    Drug: placebo
    Drug: MultiStem low dose
    Drug: MultiStem high dose
    Phase 2

    Study Type: Interventional
    Study Design: Allocation: Randomized
    Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Parallel Assignment
    Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
    Primary Purpose: Treatment
    Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Investigate The Safety And Efficacy Of Multistem(r) (PF-05285401) In Subjects With Moderate To Severe Ulcerative Colitis

    Resource links provided by NLM:

    Genetics Home Reference related topics: ulcerative colitis
    MedlinePlus related topics: Endoscopy Ulcerative Colitis
    U.S. FDA Resources

    Further study details as provided by Pfizer:

    Primary Outcome Measures:

    Incidence and severity of adverse events (at Weeks 4, 8, 12 and 16). [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
    Change from baseline of endoscopic score at Week 8 as measured by modified Baron score. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline of Mayo rectal bleeding sub-score at Week 4. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Change from baseline of Mayo rectal bleeding sub-score at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    Secondary Outcome Measures:

    Changes in laboratory measurements of safety and vital signs (at Weeks 4, 8, 12 and 16). [ Time Frame: 16weeks ] [ Designated as safety issue: Yes ]
    Change from baseline of Mayo rectal bleeding sub-score at Weeks 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes from baseline at Weeks 4, 8, 12 and 16, in the following biomarker levels: fecal calprotectin, CRP. [ Time Frame: 16weeks ] [ Designated as safety issue: No ]
    Proportions of subjects with a Mayo rectal bleeding sub-score equal 0 at Weeks 4, 8, 12 and 16. [ Time Frame: 8,16weeks ] [ Designated as safety issue: No ]
    Proportion of subjects in endoscopic remission at Week 8 (defined as subjects with a modified Baron endoscopic score equal 0). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects in clinical remission at Week 8 (defined as a total Mayo score of 2 points or lower, with no individual sub-score exceeding 1 point). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Proportions of subjects with a decrease from baseline of at least one point in Mayo rectal bleeding sub-score at Weeks 4, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with an endoscopic response at Week 8 (defined as a decrease in modified Baron endoscopic score from baseline of at least 2 points). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Proportion of subjects with a clinical response at Week 8 (defined as a decrease in total Mayo score from baseline in Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the sub-score for rectal bleeding of at least [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    1 point or an absolute sub-score for rectal bleeding of 0 or 1). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Change from baseline in total Mayo score at Week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Changes from baseline in partial Mayo score at Weeks 4, 8, 12 and 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Patient-reported rectal bleeding scores, to be modeled longitudinally up to and including Week 16. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Changes in biopsy histology score at Week 8 (measured by Riley Index). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

    Estimated Enrollment: 128
    Study Start Date: February 2011
    Estimated Study Completion Date: October 2014
    Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
    Arms Assigned Interventions
    Experimental: Cohort 1
    The first 9 subjects will be recruited into Cohort 1 and will receive either placebo (n=3) or MultiStem low dose (n=6) as an intravenous infusion on Day 1. The first five patients enrolled constitute a subgroup of Cohort 1 and these patients will receive multiple doses, once every day for 7 days for 3 doses (Day 1 and Weeks 1 & 2).
    Drug: placebo
    once every 7 days for 1- 3 doses
    Drug: MultiStem low dose
    1-3 doses
    Drug: placebo
    Single dose at week 8
    Drug: MultiStem low dose
    Single dose at week 8
    Experimental: Cohort 2
    This group will receive either placebo (n=3) or MultiStem high dose (n=6) as an intravenous infusion on Day 1. The subjects then receive the opposite dose of study medication at Week 8.
    Drug: placebo
    Single dose Day 1
    Drug: MultiStem high dose
    Single dose Day 1
    Drug: placebo
    Single dose at week 8
    Drug: MultiStem high dose
    Single dose at week 8
    Experimental: Cohort 3
    These subjects (total n=88 evaluable patients) will receive either Placebo or MultiStem (1:1 randomization) as an intravenous infusion on Day 1. In addition all subjects in Cohort 3 will receive a single infusion of either MultiStem or Placebo at Week 8, depending on their randomization schedule. A total of ~22 patients will receive an additional infusion of MultiStem, ~44 patients will receive the alternative blinded therapy to that which they received for Day 1 infusion, and ~22 patients will receive an additional infusion of placebo.
    Drug: placebo
    Single dose Day 1
    Drug: MultiStem high dose
    Single dose Day 1
    Drug: placebo
    Single dose at week 8
    Drug: MultiStem high dose
    Single dose at week 8

    Eligibility

    Ages Eligible for Study: 18 Years and older
    Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No
    Criteria

    Inclusion Criteria:

    Subjects must have a documented diagnosis of ulcerative colitis at least 6 months prior to screening.
    Subjects must have active moderate-to-severe ulcerative colitis based on Mayo score.
    Subjects must have Modified Baron endoscopic score of at least 2 determined within 7 days of first dosing.
    Subjects must have failed or be intolerant (as determined by the investigator) of at least one of the following treatments for UC: Oral corticosteroids, azathioprine or 6-mercaptopurine (6-MP), or anti-tumor necrosis factor (TNF) therapy, eg, infliximab or adalimumab.
    Subjects must be on stable steroid doses.

    Exclusion Criteria:

    Subjects who have abnormal organ and marrow function.
    Subjects with a diagnosis of indeterminate colitis, or clinical findings suggestive of Crohn's disease.
    Subjects who meet Truelove-Witts criteria for severe ulcerative colitis.
    Subjects receiving or who are expected to receive Infliximab or other biologic treatment within 8 weeks of the Day 1 study visit.
    Subjects receiving or who are expected to receive Cyclosporine, mycophenolate, or tacrolimus within 4 weeks of the Day 1 study visit.

    Contacts and Locations
    Please refer to this study by its ClinicalTrials.gov identifier: NCT01240915

    Contacts
    Contact: Pfizer CT.gov Call Center 1-800-718-1021

    Show 55 Study Locations
    Sponsors and Collaborators
    Pfizer
    Athersys, Inc
    Investigators
    Study Director: Pfizer CT.gov Call Center Pfizer
    More Information

    Additional Information:
    To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

    No publications provided

    Responsible Party: Pfizer
    ClinicalTrials.gov Identifier: NCT01240915 History of Changes
    Other Study ID Numbers: B3041001
    Study First Received: November 10, 2010
    Last Updated: November 15, 2013
    Health Authority: United States: Food and Drug Administration

    Keywords provided by Pfizer:
    safety efficacy MultiStem(r) moderate to severe Ulcerative Colitis

    Additional relevant MeSH terms:
    Colitis
    Colitis, Ulcerative
    Ulcer
    Gastroenteritis
    Gastrointestinal Diseases
    Digestive System Diseases
    Colonic Diseases
    Intestinal Diseases
    Inflammatory Bowel Diseases
    Pathologic Processes

    ClinicalTrials.gov processed this record on November 28, 2013

    Sentiment: Strong Buy

 
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