ADVENTRX To Initiate Phase 3 Study Of ANX-188
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."
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."
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on ADVENTRX's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements regarding the planned phase 3 clinical study of ANX-188, including the timing of its initiation and completion and the number of study sites open at initiation, and the impact of a forthcoming announcement of development of ANX-188 for an indication outside of sickle cell disease on its commercial and partnering prospects. Among the factors that could cause or contribute to material differences between ADVENTRX's actual results and those indicated from the forward-looking statements are risks and uncertainties inherent in ADVENTRX's business, including, but not limited to: the potential for further delays in the commencement or completion of planned clinical studies, including the phase 3 study of ANX-188 in sickle cell disease, including as a result of difficulties in completing manufacturing process development activities, manufacturing clinical trial material, meeting applicable regulatory requirements for clinical trial material, meeting applicable requirements of institutional review boards overseeing clinical study sites, negotiating agreements with potential clinical study sites, enrolling study subjects or being subject to a "clinical hold"; the risk that the rate of enrollment in the planned phase 3 study of ANX-188 is slower than was anticipated prior to the study's initiation; the impact of missing or imputed data on the treatment effect observed in the prior phase 3 study of ANX-188 in sickle cell disease; the risk of suspension or termination of a clinical study, including due to lack of adequate funding or a "clinical hold"; ADVENTRX's reliance on contract research organizations (CROs) and other third parties to assist in the conduct of important aspects of its clinical studies, and that such third parties may fail to perform as expected; the risk that planned clinical studies are not successfully executed and/or do not successfully demonstrate the safety or efficacy of the investigational drug; the risk that, even if clinical studies are successful, the
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
ADVENTRX Pharmaceuticals, Ioana C. Hone, email@example.com, +1-858-552-0866 Ext. 303