EnzymeRx Launches Clinical Study of Uricase-PEG 20

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Mon Nov 2, 2009 8:30am EST

PARAMUS, N.J.--(Business Wire)--
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.

About Uricase-PEG 20

Uricase-PEG 20 is a recombinant uricase derived from Candida utilis, modified by
the attachment of multiple 20 kilodalton molecules of polyethylene glycol
(PEG).Uricase-PEG 20 has a prolonged half-life and reduced immunogenicity
compared with unmodified uricase, and has been well tolerated in preclinical
studies and in a prior phase 1 study in gout patients.EnzymeRx is developing
Uricase-PEG 20 for the treatment of refractory gout and the management of
hyperuricemia associated with tumor lysis syndrome.

About EnzymeRx

EnzymeRx, LLC is a private, clinical stage biotechnology company founded in 2008
to develop Uricase-PEG 20.For more information about EnzymeRx, uricase, gout or
tumor lysis syndrome, please visit www.enzymerx.com.

EnzymeRx, LLC
Tony Fiorino, MD, PhD, 201-843-4424
President and Chief Executive Officer
info@enzymerx.com



Copyright Business Wire 2009

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