Investigators at University of California Describe Findings in Small Interference RNAs (siRNAs) (Correlating animal and human phase Ia/Ib clinical data with CALAA-01, a targeted, polymer-based nanoparticle containing siRNA)
By a News Reporter-Staff News Editor at Clinical Trials Week -- Current study results on Small Interference RNAs (siRNAs) have been published. According to news reporting originating in Los Angeles, California, by NewsRx journalists, research stated, "Nanoparticle-based experimental therapeutics are currently being investigated in numerous human clinical trials. CALAA-01 is a targeted, polymer-based nanoparticle containing small interfering RNA (siRNA) and, to our knowledge, was the first RNA interference (RNAi)-based, experimental therapeutic to be administered to cancer patients."
The news reporters obtained a quote from the research from the University of California, "Here, we report the results from the initial phase I clinical trial where 24 patients with different cancers were treated with CALAA-01 and compare those results to data obtained from multispecies animal studies to provide a detailed example of translating this class of nanoparticles from animals to humans. The pharmacokinetics of CALAA-01 in mice, rats, monkeys, and humans show fast elimination and reveal that the maximum concentration obtained in the blood after i.v. administration correlates with body weight across all species. The safety profile of CALAA-01 in animals is similarly obtained in humans except that animal kidney toxicities are not observed in humans; this could be due to the use of a predosing hydration protocol used in the clinic."
According to the news reporters, the research concluded: "Taken in total, the animal models do appear to predict the behavior of CALAA-01 in humans."
For more information on this research see: Correlating animal and human phase Ia/Ib clinical data with CALAA-01, a targeted, polymer-based nanoparticle containing siRNA. Proceedings of the National Academy of Sciences of the United States of America, 2014;111(31):11449-11454. Proceedings of the National Academy of Sciences of the United States of America can be contacted at: Natl Acad Sciences, 2101 Constitution Ave NW, Washington, DC 20418, USA. (National Academy of Sciences - www.nasonline.org/; Proceedings of the National Academy of Sciences of the United States of America - www.nasonline.org/publications/pnas/)
Our news correspondents report that additional information may be obtained by contacting J.E. Zuckerman, University of California, Johnsson Comprehens Canc Center, Los Angeles, CA 90095, United States. Additional authors for this research include I. Gritli, A. Tolcher, J.D. Heidel, D. Lim, R. Morgan, B. Chmielowski, A. Ribas, M.E. Davis and Y. Yen (see also Small Interference RNAs (siRNAs)).
Keywords for this news article include: Genetics, California, Los Angeles, United States, North and Central America, Small Interference RNAs (siRNAs)
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