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Calciphylaxis Clinical Study Expands to the United Kingdom

1063 Days ago

SCOTTSDALE, Ariz., June 27, 2019 (GLOBE NEWSWIRE) -- Hope Pharmaceuticals today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) approved a clinical trial application for medical centers in the United Kingdom to participate in the international investigational clinical study that is evaluating Sodium Thiosulfate Injection for the treatment of calciphylaxis-associated pain. (ClinicalTrials.gov ID: NCT03150420) 

Hope Pharmaceuticals’ international calciphylaxis clinical study is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study that is enrolling adult subjects with calciphylaxis in Canada, in the United States, and now in the United Kingdom.  Eligible subjects will be treated over a three week period to assess the effect of Sodium Thiosulfate on calciphylaxis-related pain. 

Calciphylaxis is a rare disease characterized by abnormal calcium deposits that can block blood flow in skin, muscles, and other soft tissues.  Patients with calciphylaxis develop painful skin lesions that frequently progress to deep ulcers as compromised tissues die from lack of blood flow.  These lesions can be so painful that even potent narcotics often provide very limited relief.  

Calciphylaxis is an unmet medical need as no treatment has been approved to date by regulatory authorities in Canada, the United Kingdom, and the United States.

Hope Pharmaceuticals’ Sodium Thiosulfate Injection is commercially distributed in Canada, the United Kingdom, and the United States as it has already been approved in these countries for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be life-threatening.  The international calciphylaxis clinical study is intended to support the addition of a new indication to the existing approved product labeling. 

Information about the currently approved use of Sodium Thiosulfate Injection is available online at www.thiosulfate.info.

Information about the calciphylaxis clinical study is available online at www.clinicaltrials.gov/ct2/show/NCT03150420.

Hope Pharmaceuticals is a privately owned company located in Scottsdale, Arizona. 

Media Inquiries:                    
Craig Sherman, M.D. 
+1 (480) 607-1970 or questions@hopepharm.com

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