Vaccinex Inc. Completes Enrollment of Cohort A in its SIGNAL Clinical Trial, a Randomized Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of VX15/2503 in Subjects at Risk for or with Early Signs of Huntington’s Disease
Vaccinex Inc., a clinical-stage biotechnology company engaged in the discovery and development of therapeutic monoclonal antibodies to treat patients with cancer and neurodegenerative diseases, today announced that it has completed, two months ahead of schedule, the enrollment of the first of two cohorts for its SIGNAL trial in Huntington’s Disease (HD). Subjects enrolled in the SIGNAL study are first randomized into an initial cohort A; these subjects are assigned to receive monthly infusions of either placebo or VX15/2503 for six months. All study participants are blinded to this assignment. All subjects in cohort A subsequently receive VX15/2503 for an additional six months, followed by a three-month safety review. The initial six month, blinded placebo versus VX15/2503 treatment regimen allows for direct analysis of the safety and tolerability of monthly infusions of VX15/2503 in this patient population, as well as possible changes to clinical features of HD including cognition, motor function, behavior, functional abilities and global function. Secondary assessments include preservation of brain volumes as determined by magnetic resonance imaging and control of inflammation in the central nervous system detected by positron emission imaging.
“We are very appreciative of the interest and support shown by subjects and physicians who are participating in this trial of a novel agent which may delay or prevent onset of this devastating disease,” said Maurice Zauderer, Ph.D., the CEO of Vaccinex.
Enrollment in the second cohort B has begun. Cohort B participants will be randomly assigned to receive monthly infusions of either VX15/2503 or placebo for up to 18 months, followed by 3 months of follow up. For additional information about the SIGNAL trial, please visit clinicaltrials.gov.
Source: Vaccinex Inc.