Clinical Trial Information
ENZ-101: A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Pegsitacase
This is a phase 1 study of single intravenous doses of pegsitacase (formerly Uricase-PEG 20). The study is designed to escalate through several pegsitacase doses and will yield important safety, pharmacokinetic and pharmacodynamic data on intravenous pegsitacase. Pharmacodynamics will be assessed by measuring pegsitacase levels, and pharmacodynamics by assessing uric acid levels. This study is currently enrolling subjects at sites in Pennsylvania and Florida. For more information on this study, see http://www.clinicaltrials.gov/ct2/show/study/NCT01021241.
ENZ-102: A Cohort Dose-Escalation Phase 1 Study of Intramuscular Injection of Pegsitacase
This is a phase 1 study of single and multiple intramuscular doses of pegsitacase. The study is designed to yield important safety, pharmacokinetic and pharmacodynamic data on multiple intramuscular pegsitacase doses given at two week intervals. Pharmacodynamics will be assessed by measuring pegsitacase levels, and pharmacodynamics by assessing uric acid levels. This study will be enrolling subjects at sites in Pennsylvania and Florida. For more information on this study, see http://clinicaltrials.gov/ct2/show/NCT01038947.
For more information on either study, please email us at info@enzymerx.com.
For more information
The Gout and Uric Acid Education Society
The American College of Rheumatology
The European League Against Rheumatism
The Food and Drug Administration
The National Institute of Arthritis and Musculoskeletal and Skin Diseases
Publications
Bomalaski JS, Holtsberg FW, Ensor CM, and Clark MA. Uricase formulated with polyethylene glycol (pegsitacase): biochemical rationale and pre-clinical studies. J Rheum 2002; 29:1942-1949.
(http://jrheum.org/content/29/9/1942.abstract)
Bomalaski JS and Clark MA. Serum uric acid-lowering therapies: where are we heading in management of hyperuricemia and the potential role of uricase. Curr Rheumatol Rep 2004; 6:240-247.
(http://www.current-reports.com/article_frame.cfm?PubID=RR06-3-2-05&Type=Abstract )
Zhang Z, Fiorino A. Pharmacokinetics of Intravenous Pegsitacase, a Drug for Managing Hyperuricemia in Tumor Lysis Syndrome. Abstract 3086, American Society of Hematology Annual Meeting, December 2009.
(http://ash.confex.com/ash/2009/webprogram/Paper21744.html )