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ADVENTRX Initiates Pivotal Phase 3 Study of ANX-188
Date:1/30/2013

eive a priority review voucher under the rare pediatric disease incentive program, which voucher entitles the holder to priority (6-month) review of a new drug or biologics license application and which voucher can be sold prior to being used.  This year, we plan to seek designation of ANX-188 as a drug for a rare pediatric disease." 

About EPIC (Evaluation of Purified 188 In Crisis)

The EPIC study is a randomized, double-blind, two-arm, placebo-controlled study that will be conducted at approximately 40 sites, primarily in the U.S.  The primary objective is 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.

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 arisi
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SOURCE ADVENTRX Pharmaceuticals, Inc.
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4. ADVENTRX Applauds Inclusion of Rare Diseases Provisions in the FDA Safety and Innovation Act
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