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Industry Group Releases Safety Testing Recommendations for Oligonucleotide-Based Therapeutics
New Rochelle, NY, July 8, 2014—Novel oligonucleotide-based drugs in development offer promising alternatives for treating a range of diseases. A group of industry and regulatory scientists developing these new nucleic acid-based therapies released consensus recommendations for evaluating the pharmacological safety of oligonucleotide therapeutics. The document is published in Nucleic Acid Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc. publishers. The article is available on the Nucleic Acid Therapeutics website.
Cindy Berman and coauthors from Pfizer Pharmaceuticals, GlaxoSmithKline, Preclinsight, Merck Sharp & Dohme Corp., Tepper Nonclinical Consulting, and Isis Pharmaceuticals provide the consensus opinion of the Safety Pharmacology Subcommittee of the Oligonucleotide Safety Working Group in the article “Recommendations for Safety Pharmacology Evaluations of Oligonucleotide-Based Therapeutics”. The recommendations emphasize in particular the importance of safety pharmacology studies to evaluate the potential effects of systemically administered oligonucleotide-based drugs on cardiovascular function.
“It is our hope that during this period of rapid advancement both regulators and researchers alike will recognize and benefit from these carefully considered safety testing recommendations,” 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.
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 free sample issue may be viewed on the Nucleic Acid Therapeutics website.
About the Society
The Oligonucleotide Therapeutics Society is an open, nonprofit forum to foster academia- and industry-based research and development of oligonucleotide therapeutics. The society brings together the expertise from different angles of oligonucleotide research to create synergies and to bring the field of oligonucleotides to its full therapeutic potential.
About the Publisher
Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many areas of science and biomedical research, including Human Gene Therapy, Human Gene Therapy Methods, Human Gene Therapy Clinical Development, ASSAY and Drug Development Technologies, and DNA and Cell Biology. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry’s most widely read publication worldwide. A complete list of the firm’s 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.