SAN DIEGO, Dec. 19, 2012 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that ANX-188 drug product for use in the phase 3 clinical study of ANX-188 (purified poloxamer 188), manufactured using the Company's proprietary purification process, has passed quality control (QC) release specifications at Patheon, the Company's contract manufacturer, and currently is in the quality assurance (QA) release process. The study has been approved by multiple institutional review boards (IRB) and initiation of the study is expected in approximately six weeks.
Santosh Vetticaden, Chief Medical Officer, said: "Our clinical operations team has achieved numerous milestones over the past several months that will allow us to initiate the EPIC study as early as next month. We have multiple IRB approvals, multiple clinical trial agreements with study sites, and we have assembled a top-flight data safety monitoring board. Last week, we held our first investigators' meeting, and I was impressed by the level of enthusiasm for the study that was expressed by leaders in the sickle cell disease medical community."
Brian M. Culley, Chief Executive Officer, said: "We were expecting to initiate the study prior to year-end, but unforeseen delays at one of our vendors will push trial initiation into early next year. However, this upfront delay means we will have more sites open at study initiation and the delay will not extend the overall study timeline. Our focus now is on releasing drug product and shipping it to our contract facility on the East Coast, where it will be labeled and distributed to clinical sites, all of which we expect to take place over the next few weeks. In parallel, we continue to qualify and open additional study sites."
Mr. Culley continued: "Looking ahead, we are preparing to initiate a thorough QT study of ANX-188 and announce our plans to develop ANX-188 in an indication outside of sickle cell disease, which will further increase the commercial potential of, and partnering interest in, this important investigational drug."
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