Marina Biotech, Inc. has announced that its presentation of long term toxicology data at the 102nd AACR Annual Meeting. An initial analysis of the results of the recently completed CEQ508 long-term toxicology study in non-human primates identified the preliminary No Observed Adverse Effect Level (NOAEL) as 1x10(11) colony forming units (cfu)/day, the highest dose administered in the toxicology study as well as the highest dose anticipated in the Dose Escalation Phase of the human clinical trial.
The poster presentation titled "Long term safety observed with CEQ508: An oral RNAi drug targeting beta-catenin of GI polyps" will be presented by Alison Silva, Vice President, Drug Development at Marina Biotech on Monday, April 4 from 1:00 to 5:00pm at the Orange County Convention Center in Orlando, Florida.
"We're very pleased to be presenting this look at the safety data from our non-human primate study," stated J. Michael French, President and CEO at Marina Biotech.
French continued, "This study establishes a very strong safety profile supporting the long-term and daily use of our orally administered Familial Adenomatous Polyposis (FAP) therapeutic candidate. As we advance further into clinical development, the results of this study will be used to determine the duration and design of our Phase 2b trial. With the recent announcement of first-in-man patient enrollment in the START-FAP (Safety and Tolerability of An RNAi Therapeutic in FAP) trial, we continue to execute on our clinical and regulatory plan to commercialize this product by 2014."