ADVENTRX Pharmaceuticals Inc. Engages Theradex® to Manage Phase 3 Clinical Study of ANX-188
Published: Oct 02, 2012
SAN DIEGO, Oct. 2, 2012 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that it has engaged Theradex® Systems, Inc., a contract research organization with 30 years of experience, to manage the Company's upcoming phase 3 study of ANX-188 (purified poloxamer 188) in sickle cell disease.
"The engagement of Theradex is one of the final steps before initiating our phase 3 study of ANX-188 in patients with sickle cell disease experiencing vaso-occlusive crisis," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "We selected Theradex based on its extensive experience in the management and oversight of clinical trials, which includes studies in patients with sickle cell disease and a 29-year collaboration with the National Cancer Institute in the United States. We are confident in Theradex's ability to assist us in executing a high-quality, efficient phase 3 study of ANX-188."
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company developing proprietary product candidates to treat various diseases and conditions. The Company's lead product candidate, ANX-188, has potential to reduce ischemic tissue injury and end-organ damage by restoring microvascular function which is compromised in a wide range of serious and life-threatening diseases and conditions. The Company initially is developing ANX-188 as a treatment for complications arising from sickle cell disease. More information can be found on the Company's web site at www.adventrx.com.
About Theradex Systems, Inc.
Theradex is an international contract research organization providing complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases. Theradex® conducts studies which lead to marketing approval of significant medical advances; and has built a reputation on assuring the scientific objectivity and meticulous quality control that fulfills all regulatory requirements. For 29 years, Theradex has held the Clinical Trials Monitoring Service Contract for the National Cancer Institute in the United States. Theradex's clients include international biotech and pharmaceutical companies.
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 ADVENTRX's development plans for ANX-188, including the nature and timing of future clinical studies, and Theradex's potential impact on such studies. 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 delays in the commencement or completion of planned clinical studies including as a result of difficulties or delays in completing manufacturing process development activities and manufacturing clinical trial material or difficulties or delays in obtaining regulatory agreement on clinical study design or meeting applicable regulatory requirements for clinical trial material; the risk of suspension or termination of a clinical study including due to lack of adequate funding; the risk that planned clinical studies are not successful and, even if they are successful, that the FDA could determine they are not sufficient to support an NDA for the product candidate; the potential for ADVENTRX to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner its product candidates at inopportune times or pursue less expensive but higher-risk development paths if it is unable to raise sufficient additional capital as needed; ADVENTRX's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the risk that the FDA does not grant marketing approval of ADVENTRX's product candidates, including ANX-188, on a timely basis, or at all; ADVENTRX's reliance on third parties to assist in the conduct of important aspects of its product candidates' development programs, including the manufacture of clinical trial material, the conduct of clinical studies and preparation of regulatory submissions related to product approval, and that such third parties may fail to perform as expected; and other risks and uncertainties more fully described in ADVENTRX's press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX's public filings with the Securities and Exchange Commission are available at www.sec.gov.
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.
SOURCE ADVENTRX Pharmaceuticals, Inc.