SIGNAL

SIGNAL: A new investigational approach to early treatment of Huntington’s disease

Vaccinex and the Huntington Study Group (HSG) launched a new trial for people with the gene mutation that causes HD who are either early in the progression of the disease or are not yet diagnosed with the disease.

The SIGNAL trial is designed to assess the safety, tolerability, and effectiveness of VX15, a novel monoclonal antibody in people with late prodromal or early manifest Huntington’s disease (HD). It is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study at 20 sites across the United States that seeks to enroll approximately 116 individuals, 21 or older, who are either early in the progression of the disease or are not yet diagnosed with the disease.

The investigational compound that will be studied in the trial is VX15, a monoclonal antibody. This is a different class of drug than any other drug used in previous HD clinical trials. Monoclonal antibodies are more specific than most other drugs because they only bind to and neutralize their desired target. Previous research suggests that VX15 may have the potential to slow the progression of brain inflammation, which has been shown to impair thinking, movement, and behavior in HD animal models.

VX15 has not been approved by the FDA; its potential benefits for HD are being investigated within the SIGNAL trial.

The VX15 antibody is designed to respond specifically to the semaphorin 4D (SEMA4D) protein, a molecule that guides the activation and movement of cells within the body. In HD, VX15 has the potential to block SEMA4D, which may be responsible for inflammation in the brains of individuals who develop HD. Reducing brain inflammation may slow HD’s subsequent effects, including impaired cognition, movement, and behavior.

The study procedures involves:

  • A screening visit to confirm eligibility. Approved subjects will complete a baseline visit and then begin the investigational period
  • Once a month drug or placebo delivery through an approximately hour-long intravenous infusion
  • Brain imaging and cognitive testing during specified visits – these monthly visits may take a full day to complete
  • Lumbar puncture for collection of cerebrospinal fluid for subjects in Cohort B who volunteer
  • Safety, tolerability, and efficacy assessments will be performed at all visits
  • Subjects will be treated with drug or placebo intravenous infusion for 12-18 months
    • Cohort A will receive drug or placebo for six months and then for the next six months, all participants will receive drug. (Enrollment in Cohort A is now complete. To view the press release from Vaccinex, click here. To view press release from Vaccinex about preliminary imaging data from Cohort A, click here.) 
    • Cohort B will receive drug or placebo for 18 months.
  • A follow-up period includes a follow-up safety phone call at one month and a follow-up safety visit at three months after the final infusion.

SIGNAL participants may enroll in observational studies, but they cannot participate in other clinical trials of investigational compounds. Participants may still be eligible for SIGNAL if they are taking other prescribed medications.

To participate, you must visit your chosen site on a monthly basis during the trial period.

Participating sites and contact information:


      Columbia University Medical Center

      New York, NY

      Paula Wasserman, coordinator

       pl2032@cumc.columbia.edu

       (212) 305-4597

       

      Duke University

      Durham, NC

      Peggy Perry-Trice, coordinator

       peggy.perrytrice@duke.edu

       (919) 684-0865

       

      Emory University School of Medicine

      Atlanta, GA

      Elaine Sperin, coordinator

       esperin@emory.edu

       (404) 712-7044

       

      Georgetown University

      Washington, DC

      Hope Heller, coordinator

       hope.heller@medstar.net

       (202) 687-1366

       

      Massachusetts General Hospital

      Boston, MA

      Courtney Jordan, coordinator

      cljordan@mgh.harvard.edu

       (617) 724-2227

       

      Ohio State University

      Columbus, OH

      Allison Daley, coordinator

       allison.daley@osumc.edu

       (614) 688-8672

       

      University of Alabama at Birmingham

      Birmingham, AL

      Jenna Smith, coordinator

       jennat@uab.edu

       (205) 996-2807

       

      University of California, San Diego

      San Diego, CA

      Sungmee Park, coordinator

      Sup035@ucsd.edu

      (858) 249-0568

       

      University of Cincinnati

      Cincinnati, OH

      Hilary Perez, coordinator

       hilary.perez@uc.edu

       (513) 558-0112

       

      University of Colorado

      Aurora, CO

      Mary Cook, coordinator

       mary.m.cook@ucdenver.edu

       (303) 724-7968

       

      University of Iowa

      Iowa City, IA

      Terry Hayes, coordinator

       terry-hayes@uiowa.edu

       (319) 353-4438

       

      University of Louisville

      Louisville, KY

      Annette Robinson, coordinator

       annette.robinson@louisville.edu

       (502) 540-3585

       

      University of Michigan

      Ann Arbor, MI

      Elizabeth Sullivan, coordinator

       elizsull@med.umich.edu

       (734) 232-6247

       

      University of Rochester

      Rochester, NY

      Amy Chesire, coordinator

       amy_chesire@urmc.rochester.edu

       (585) 341-7519

       

      University of Toledo

      Toledo, OH

      Julia Spears, coordinator

       julia.spears@utoledo.edu

       (419) 383-6728

       

      University of Vermont

      Burlington, VT

      Emily Houston, coordinator

       emily.houston@uvm.edu

       (802) 656-8989

       

      Vanderbilt University

      Nashville, TN

      Philip Siragusa, coordinator

      philip.w.siragusa@Vanderbilt.edu

      (615) 875-1182

       

      Wake Forest University

      Winston Salem, NC

      Christine O’Neill, coordinator

       coneill@wakehealth.edu

       (336) 716-8611

       

      Washington University

      St. Louis, MO

      Melissa Ammel, coordinator

       ammelm@neuro.wustl.edu

       (314) 747-3470

       

       

       

      Enrollment in Cohort A is now complete. To view the press release from Vaccinex, click here. To view a press release from Vaccinex about preliminary imaging data from Cohort A, click here.

      If you or someone close to you is interested in taking part in SIGNAL, or if you would like additional information or have questions regarding the study, please contact a site near you or the Huntington Study Group at 1-800-487-7671 or info@hsglimited.org.

      To view the brochure about the trial, click here: Signal Flyer
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      Listen to Dr. Andy Feigin, principal investigator, talk about the SIGNAL trial on Help4HD’s radio blog on the Aug. 14, 2015, episode.