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Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders
Date:10/23/2007

SOUTH SAN FRANCISCO, Calif., Oct. 23 /PRNewswire/ -- Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in a Phase 1/2 clinical trial of Glyceryl Tri (4-Phenylbutyrate) (GT4P) in patients with urea cycle disorders (UCDs).

(Logo: http://www.newscom.com/cgi-bin/prnh/20070905/AQW076LOGO)

"UCDs are complex disorders which require a multi-faceted management approach, including a protein restricted diet, amino acid supplementation, and pharmacological therapy," said Brendan Lee, M.D., Ph.D. the first investigator to enroll a patient in the GT4P Phase 1/2 trial and Professor, Department of Molecular and Human Genetics at Baylor College of Medicine. "We look forward to seeing the results from the clinical trials of GT4P in the management of UCDs."

The phase 1/2 study is designed to evaluate the safety, tolerability and ammonia scavenging effects of GT4P compared to BUPHENYL(R) (sodium phenylbutyrate) in patients with UCDs. A total of up to ten adults with stable UCD will be included in the trial, which is being conducted at US-based clinical sites. Estimated duration of treatment is 3 to 4 weeks.

"We are very excited about our research of GT4P focused on the chronic management of urea cycle disorders," said Marvin Garovoy, Senior Vice President of Clinical Development of Hyperion Therapeutics, Inc. "Initiation of this trial marks the beginning of several Hyperion clinical programs aimed at developing new therapies for hepatic disease."

About GT4P

GT4P is composed of a glycerol backbone covalently attached via ester linkages to three molecules of phenylbutyrate. It is a prodrug of BUPHENYL(R) (a currently FDA-approved adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic aci
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SOURCE Hyperion Therapeutics, Inc.
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