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ADVENTRX Announces Details Of The Phase 3 Study Of ANX-188
Date:10/25/2012

SAN DIEGO, Oct. 25, 2012 /PRNewswire/ -- ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX) today provided details regarding the phase 3 clinical study of ANX-188 (purified poloxamer 188) in sickle cell disease that it plans to initiate this quarter.  The Company will host a conference call today at 4:30 p.m. Eastern Time, 1:30 p.m. Pacific Time (access information below) to discuss the study. 

The study will be a randomized, double-blind, two-arm, placebo-controlled study conducted at approximately 40 sites primarily in the U.S.  The primary objective will be to demonstrate that ANX-188 reduces the duration of vaso-occlusive crisis in patients with sickle cell disease.  The duration of vaso-occlusive crisis will be measured from the time a subject is randomized to the time at which the subject receives the last dose of parenteral opioid analgesic for the treatment of vaso-occlusive crisis prior to hospital discharge.  A total of 388 subjects ages 8 to 17 who have sickle cell disease and are experiencing acute pain typical of vaso-occlusive crisis will be enrolled.  Using a two-sided alpha of 0.05, the study has approximately 90% power to detect a 16-hour difference between treatment arms.  Secondary endpoints will compare re-hospitalization rate (for vaso-occlusive crisis) within 14 days of initial discharge from the hospital and the occurrence of acute chest syndrome within 120 hours of randomization. 

"Following an iterative and collaborative dialog with the FDA, and with valuable input from physicians who treat sickle cell patients, we are pleased to have finalized our phase 3 study protocol.  Consistent with our plans when we acquired ANX-188, the study will focus on children.  In a post-hoc analysis of a prior phase 3 study, ANX-188 demonstrated a statistically significant reduction in the duration of crisis in a subgroup of younger patients.  With the improvements we have incorporated into
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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