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.
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.
The article is available on the Nucleic Acid Therapeutics website.