Published on November 2, 2009 at 10:02 AM
EnzymeRx, LLC (www.enzymerx.com), a clinical-stage biotechnology company, today announced that it has launched its first clinical study of Uricase-PEG 20. Subjects have begun enrolling in a phase 1 safety, pharmacokinetic and pharmacodynamic study of single intravenous doses of Uricase-PEG 20. Last month, EnzymeRx announced that its Investigational New Drug application for intravenous Uricase-PEG 20 had become effective. EnzymeRx is pursuing the development of Uricase-PEG 20 as an intravenous agent for the management of elevated uric acid associated with tumor lysis syndrome, and as an intramuscular agent for the treatment of refractory gout.
Tony Fiorino, MD, PhD, President and Chief Executive Officer of EnzymeRx, remarked: “Our team has worked very diligently with the study sites and with Kendle to launch this clinical trial after receiving FDA clearance last month. Sites are screening potential enrollees, and several subjects have already received Uricase-PEG 20.” John Bomalaski, MD, Chief Medical Officer of EnzymeRx, added: “It is gratifying to see Uricase-PEG 20 back in the clinic. This study will provide important information on the safety, tolerability, pharmacokinetics and uric acid lowering capacity of Uricase-PEG 20 administered intravenously, and will allow us to proceed to future development in tumor lysis syndrome.”
Gout and tumor lysis syndrome are both associated with elevated levels of uric acid. Tumor lysis syndrome is a serious condition that can occur during the treatment of certain tumors, and can result in sharply elevated uric acid levels. Uricase-PEG 20 metabolizes poorly soluble uric acid into highly soluble allantoin, and in a prior phase 1 clinical trial, it was shown to lower uric acid levels in gout patients. Because its long half-life may provide for an extended duration of uric acid-lowering after just a single dose, Uricase-PEG 20 may offer a convenient alternative to existing therapies for tumor lysis syndrome.
Source EnzymeRx