ROCHESTER, N.Y., September 9, 2016 (GLOBE NEWSWIRE) – 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 a pre-planned interim analysis of the six month double-blind portion of the SIGNAL trial was completed. The SIGNAL trial is a Phase 2 clinical trial of investigational VX15/2503 antibody for the potential treatment of Huntington’s disease (HD).
The SIGNAL trial experience to date has shown that recruitment into this first study of a biologic administered intravenously to late prodromal and early manifest HD subjects is feasible and that participant retention and compliance with the study protocol have compared favorably with prior experience in other HD studies. A pre-specified interim analysis of data from six months of double-blind treatment with VX15/2503 or placebo (Cohort A) was completed in August 2016.
No safety signals were identified that warranted stopping or modifying the study.
In June 2015, Vaccinex, the Huntington Study Group (HSG), and the University of Rochester’s Clinical Trials Coordination Center launched SIGNAL, the first clinical trial to investigate a monoclonal antibody as a potential treatment for HD. The study consists of two cohorts, A and B. Thirty-six participants were randomized into Cohort A to receive monthly infusions of either VX15/2503 or placebo for six months, in a double-blind fashion. All Cohort A participants will subsequently receive open-label VX15/2503 for six months, followed by a three-month safety follow-up. Enrollment in Cohort A was completed in December 2015, two months ahead of schedule.
Enrollment in Cohort B has also been completed. Participants in Cohort B were randomized to receive monthly infusions of either VX15/2503 or placebo in a double-blind fashion for 18 months, followed by three months of follow up.
“We appreciate the interest in the SIGNAL trial from physicians and the HD community, and we are especially grateful to the participants who are helping to investigate VX15/2503 as a potential treatment for HD,” said Maurice Zauderer, PhD, CEO of Vaccinex.
For more information about the SIGNAL trial and enrollment, visit the Huntington Study Group website, www.huntingtonstudygroup.org.
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. We believe that recent advances have made this technology very efficient for selection of antibodies against membrane associated proteins, an important class of target molecules for pharmaceutical development. Vaccinex is based in Rochester, New York. For more information and to contact Vaccinex (email@example.com) or visit www.vaccinex.com.
About the Huntington Study Group (HSG)
The Huntington Study Group is an independent, not-for-profit network of 400 researchers, coordinators, and other clinicians at more than 100 academic medical centers in the United States, Canada, Australia, New Zealand, South America, and Europe, that work together to seek treatments that make a difference for people affected by Huntington disease. It has facilitated more than 30 clinical trials and studies in HD with more than 10,000 at-risk, prodromal and manifest HD participants.
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 expectations related to 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.
Contact: Glen Losev
Director, Investor Relations & Corporate Communications