Singapore, Mar 02, 2010: EnzymeRx, a clinical-stage biotechnology company has announced completion of the enrollment of its first clinical trial of pegsitacase (formerly called Uricase PEG 20), and the recent launch of a second clinical study. Pegsitacase is a pegylated uricase being developed by EnzymeRx for the treatment of refractory gout and for the management of hyperuricemia associated with tumor lysis syndrome.
The completed trial was a phase I safety, pharmacokinetic and pharmacodynamic study of single ascending intravenous doses of pegsitacase. The study sequentially enrolled five cohorts of four subjects each, with each cohort receiving escalating single doses of pegsitacase administered by intravenous infusion over one hour, without any premedication. Tony Fiorino, President and Chief Executive Officer of EnzymeRx, remarked: “It is truly gratifying to have completed enrollment in our first clinical study of pegsitacase. The drug was extremely well tolerated in these subjects, with no infusion reactions, and we are very pleased with the potency and duration of uric acid-lowering that we have seen thus far. We plan to present the results from this study at a medical conference later in 2010.”
John Bomalaski, Chief Medical Officer of EnzymeRx, noted: “With the completion of the single dose intravenous study, EnzymeRx is now positioned to move pegsitacase forward in tumor lysis syndrome. Similarly, the recently launched multi-dose intramuscular study will, once completed, allow pegsitacase to move into phase 2 development in gout. We have a busy year planned in both indications, and are very excited by the clinical profile exhibited by pegsitacase in the single dose intravenous setting.”
Gout is a painful arthritic caused by the formation of uric acid crystals in the joints, and tumor lysis syndrome, a serious condition that can occur during the treatment of certain tumors, are both associated with elevated levels of uric acid.
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