From BioWorld Insight (August 20, 2012) .
... There are a number of early stage clinical trials underway being conducted by biotechnology companies. Tekmira Pharmaceuticals Corp., of Vancouver, for example, has released interim results demonstrating that its RNAi compound TKM-PLK1 in patients with advanced solid tumors is showing promising signs of drug activity in an ongoing Phase I clinical trial. The trial, conducted at oncology centers in the U.S., is an open label, multi-dose, dose escalation study designed to evaluate the safety, tolerability and pharmacokinetics of TKM-PLK1 as well as determine the maximum tolerated dose. Secondary objectives of the trial are to measure tumor response and the pharmacodynamic effects of TKM-PLK1 in patients providing biopsies.
RXi Pharmaceuticals Corp., of Worcester, Mass., has initiated a dose-escalating Phase I trial of its RNAi compound RXI-109, which incorporates self-delivering RNAi technology, for skin scarring following trauma or surgery. And Sylentis SA, of Madrid, Spain, a subsidiary of Grupo Zeltia SA, received authorization from Spanish and Estonian regulatory agencies to begin Phase II trials of RNAi therapeutic SLY040012 for ocular hypertension of glaucoma, looking at efficacy for a range of doses.
Alnylam also has entered several RNAi drugs into clinical trials and is the leading RNAi therapeutic company, said Piper Jaffray analyst Edward A. Tenthoff in a research note. It has initiated a Phase II dose-escalation study of ALN-TTR02 in 20 TTR-amyloidosis patients and plans to begin a pivotal trial in 2013.
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