SCOTTSDALE, Ariz., June 05, 2018 (GLOBE NEWSWIRE) — Hope Pharmaceuticals today announced enrollment of the first Canadian subject to participate in the CALISTA clinical study that is evaluating Sodium Thiosulfate Injection for the treatment of calciphylaxis (calcify uremic arteriolopathy, CUA).
CALISTA is an international, Phase 3, double-blind, placebo-controlled multicenter study that plans to enroll 111 adult patients with calciphylaxis. Eligible patients will be treated at participating medical centers in Canada and the United States over a three-week period to assess the effect of Sodium Thiosulfate on calciphylaxis-related pain.
Calciphylaxis is a rare disease characterized by abnormal calcification in soft tissues. Patients with calciphylaxis frequently develop painful skin lesions. These lesions can be so painful that narcotics often provide very limited relief.
Sodium thiosulfate is an agent with possible antioxidant, calcium-chelating, and/or vasodilatory properties.
Calciphylaxis is an unmet medical need as no treatment has been approved to date by Health Canada. Similarly, no treatment for calciphylaxis has been approved in the United States or Europe. Based on favorable reviews of existing clinical data, both the Food and Drug Administration in the United States and the European Medicines Agency (EMA) in the European Union granted Orphan Product designation to Hope Pharmaceuticals’ Sodium Thiosulfate for the treatment of calciphylaxis. Orphan drug programs in the United States and elsewhere evaluate scientific and clinical data submissions from companies to identify and designate products as promising for rare diseases and to further advance scientific development of such promising medical products.
Craig Sherman M.D., President of Hope Pharmaceuticals said, “The enrollment of the first international subject in the CALISTA study is a significant milestone in the clinical development of Sodium Thiosulfate for calciphylaxis. If the trial is successful, it will provide hope to patients with this devastating disease.”
Hope Pharmaceuticals’ Sodium Thiosulfate Injection is currently distributed in Canada and the United States as it has already been approved by Health Canada and the U.S. Food and Drug Administration as an antidote for acute cyanide poisoning that is judged to be life-threatening.
Additional information about Sodium Thiosulfate Injection is available online at www.thiosulfate.info.
Hope Pharmaceuticals is a privately owned company located in Scottsdale, Arizona.
Craig Sherman, M.D.
(480) 607-1970 or firstname.lastname@example.org
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/a3314fe1-6c36-46e7-a29c-9292990d4968