New guidelines for reproductive & developmental toxicity testing of oligonucleotide drugs

PUBLIC RELEASE DATE:

30-Oct-2014

Contact: Kathryn Ryan kryan@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News @LiebertOnline

New Rochelle, NY, October 30, 2014Oligonucleotide-based therapeutics present unique challenges when it comes to testing their potential to cause reproductive and developmental harm. New consensus guidelines for toxicity testing that take into consideration the combined chemical and biological characteristics of these novel biopharmaceuticals are presented in Nucleic Acid Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc. publishers. The article is available free on the Nucleic Acid Therapeutics website until November 30, 2014.

Joy Cavagnaro, Access BIO (Boyce, VA), Cindy Berman, Berman Consulting (Wayland, MA), Doug Kornbrust, Preclinisight (Reno, NV), Tacey White, Exponent (Philadelphia, PA), Sarah Campion, Pfizer (Groton, CT), and Scott Henry, Isis Pharmaceuticals (Carlsbad, CA), coauthored the white paper that highlights key points to consider in the design of scientifically valid and predictive toxicity studies. The authors summarize the findings of the Reproductive Subcommittee of the Oligonucleotide Safety Working Group (OSWG) in the article "Considerations for Assessment of Reproductive and Developmental Toxicity of Oligonucleotide-Based Therapeutics."

"I highly commend this latest white paper from the OSWG to researchers and regulators alike involved in the development and implementation of oligonucleotide or antisense based interventions," says Executive Editor Graham C. Parker, PhD, The Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine, Children's Hospital of Michigan, Detroit, MI.

Nucleic Acid Therapeutics is under the editorial leadership of Co-Editors-in-Chief Bruce A. Sullenger, PhD, Duke Translational Research Institute, Duke University Medical Center, Durham, NC, and C.A. Stein, MD, PhD, City of Hope National Medical Center, Duarte, CA; and Executive Editor Graham C. Parker, PhD.

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About the Journal

Nucleic Acid Therapeutics is an authoritative, peer-reviewed journal published bimonthly in print and online that focuses on cutting-edge basic research, therapeutic applications, and drug development using nucleic acids or related compounds to alter gene expression. Nucleic Acid Therapeutics is the official journal of the Oligonucleotide Therapeutics Society. Complete tables of content and a sample issue may be viewed on the Nucleic Acid Therapeutics website.

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New guidelines for reproductive & developmental toxicity testing of oligonucleotide drugs