Mast Therapeutics Completes Patient Enrollment In Pivotal Phase 3 "EPIC" Study For The Treatment Of Sickle Cell Crisis
The EPIC study was conducted under the direction of Principal Investigator
"The full enrollment of EPIC is an important achievement in the history of sickle cell disease clinical development, as it represents the largest placebo-controlled clinical trial conducted to date for our patients with this disease," stated
"As physicians, we are frustrated by our inability to offer patients a disease-modifying treatment for an ongoing crisis," stated
"We are proud to have completed enrollment in the EPIC study," stated
"Following the last patient's discharge from the hospital and 30-day safety observation period, there will be an extensive and rigorous review of the blinded data for quality control, ultimately leading to database lock. Study unblinding then will be performed by the study biostatistician. After the biostatistician's work is complete, Mast will learn the top-line outcome of the study from the biostatistician and will be able to report top-line results to the public," continued Mr. Culley.
About the EPIC Study
The EPIC study is a randomized, double-blind, two-arm, placebo-controlled, Phase 3 clinical trial of vepoloxamer in patients with sickle cell disease hospitalized for treatment of vaso-occlusive crisis. The primary objective of the study is to demonstrate that vepoloxamer reduces the duration of vaso-occlusive crisis, with the duration of crisis measured from the time a patient is randomized to the time at which the patient receives the last dose of parenteral opioid analgesic for the treatment of vaso-occlusive crisis prior to hospital discharge. A total of 388 patients, ages four to 46 were enrolled in EPIC. Secondary efficacy endpoints are to compare the rates of re-hospitalization for vaso-occlusive crisis within 14 days of initial hospital discharge and the occurrence of acute chest syndrome within 120 hours of randomization between the treatment and control groups.
About Sickle Cell Disease and Vaso-Occlusive Crisis
Sickle cell disease is a chronic, genetic blood disorder that affects millions worldwide and an estimated 90,000 to 100,000 people in
About Mast Therapeutics
Vepoloxamer is an investigational new drug being evaluated in a pivotal Phase 3 study called EPIC for the treatment of vaso-occlusive crisis in patients with sickle cell disease and in a Phase 2 study for the treatment of patients with chronic heart failure. AIR001 is in Phase 2 clinical development for the treatment of patients with HFpEF. More information can be found on the Company's web site at www.masttherapeutics.com. (Twitter: @MastThera)
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Mast Therapeutics, Ioana C. Hone (firstname.lastname@example.org), 858-552-0866 Ext. 303