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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
ROCHESTER, N.Y., January 4, 2016 – 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.
About Vaccinex, Inc.
Vaccinex, Inc. is a privately held clinical-stage immunotherapy company engaged in the discovery and development of human therapeutic monoclonal antibodies to treat cancer and neurodegenerative diseases, including Huntington’s disease. Vaccinex utilizes its proprietary ActivMAb® Antibody Discovery Technology for rapid, mammalian cell-based antibody selection to build its antibody pipeline and in service to its biopharmaceutical partners. ActivMAb® combines the advantages of rapid and sensitive selection by virus panning and cell sorting in one technology, with intrinsic selection of antibodies that are efficiently expressed and stable in mammalian cells, which we believe has advantages relative to other selection technologies. Vaccinex is based in Rochester, New York. For more information and to contact Vaccinex (email@example.com) or visit www.vaccinex.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements reflecting the current beliefs and expectations of management. Words such as “may,” “believe,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions, as well as other words or expressions referencing future events, conditions or circumstances, are intended to identify forward-looking statements. Forward-looking statements contained in this press release include statements about the initiation of a Phase 2 clinical trial for the Company’s lead monoclonal antibody, VX15/2503. Forward-looking statements in this press release involve substantial risks and uncertainties that could cause our performance or achievements to differ significantly from those expressed or implied by the forward-looking statements, including as a result of the inherent challenges in clinical development. All forward-looking statements are based on Vaccinex’s expectations and assumptions as of the date of this press release, and actual results may differ materially. Except as required by law, Vaccinex expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.