Navigation Links
Hyperion Therapeutics Completes Phase 2 Data Analysis and Schedules End of Phase 2 Meeting With FDA for HPN-100 in the Chronic Treatment of Urea Cycle Disorders
Date:11/12/2008

SOUTH SAN FRANCISCO, Calif., Nov. 12 /PRNewswire/ -- Hyperion Therapeutics, Inc. today reported completion of data analysis for its Phase 2 clinical trial designed to evaluate the safety, tolerability and ammonia scavenging effects of HPN-100 versus BUPHENYL(R) (sodium phenylbutyrate), the current standard of care in patients with urea cycle disorders. Data from the trial will be presented at an upcoming medical conference.

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

"We are encouraged by this trial and the potential to develop a new therapy for patients with urea cycle disorders," said Dr. Bruce Scharschmidt, Senior Vice President and Chief Medical Officer of Hyperion Therapeutics, Inc. "Based on the results, we plan to meet with the Food and Drug Administration in early 2009 to discuss our Phase 3 development program."

"We are pleased with the progress of the HPN-100 clinical program," said Cindy LeMons, Executive Director of the National Urea Cycle Disorders Foundation (NUCDF). "The urea cycle disorder community encourages the development of treatment alternatives."

Hyperion and Ucyclyd Pharma, Inc., a subsidiary of Medicis Pharmaceutical Corporation, entered into a collaboration agreement for HPN-100 in August 2007. Under the terms of the agreement, Hyperion is conducting ongoing research and development of HPN-100 for urea cycle disorders, hepatic encephalopathy, and other forms of hyperammonemia.

About Urea Cycle Disorder

Urea cycle disorders are inherited, inborn errors of metabolism present in an estimated 1 in 10,000 births in the United States. Patients with urea cycle disorders are deficient in one of the key enzymes that comprise the urea cycle, the body's primary vehicle for removing ammonia, a potent neurotoxin, from the bloodstream. Onset may occur at any age depending on the severity of the disorder. Left untreated, urea cycle disorders can cause dangerously heightened levels of ammonia in the bloodstream (hyperammonemia) resulting in brain damage, coma, and/or death.

About HPN-100

HPN-100 is a pro-drug of phenylbutyrate and a pre-pro-drug of phenylacetic acid, the active moiety of BUPHENYL(R), the only therapy currently FDA-approved as adjunctive therapy for the chronic management of patients with the most prevalent urea cycle deficiencies including those related to carbamylphosphate synthetase, ornithine transcarbamylase and argininosuccinic acid synthetase. HPN-100, which is dosed orally in liquid form, provides an alternative pathway to the urea cycle for the disposal of waste nitrogen through the renal excretion of phenylacetylglutamine, which is formed from phenylacetic acid and glutamine.

About BUPHENYL(R)

BUPHENYL(R) is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). BUPHENYL(R) should not be administered to patients with known hypersensitivity to sodium phenylbutyrate or any component of this preparation. The most common adverse reactions associated with BUPHENYL(R) were amenorrhea dysfunction, decreased appetite, body odor (probably caused by its metabolite phenylacetate) and bad taste or taste aversion. Patients with urea cycle disorders should not take valproic acid, haloperidol, or steroids as these drugs have been reported to increase blood ammonia levels, and probenecid may affect the kidneys' excretion. Use with great care, if at all, in patients with congestive heart failure or severe renal insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established.

About NUCDF

The National Urea Cycle Disorders Foundation is a nationally-recognized nonprofit organization dedicated to saving children and adults from the catastrophic effects of urea cycle disorders. The Foundation is a lifeline to families and medical professionals all over the world desperately seeking crisis intervention and treatment information. The Foundation's mission is to provide information, guidance and support to patients and their families, to educate healthcare professionals on the identification, diagnosis and treatment of UCDs, to raise awareness so that no child or adult ever goes undiagnosed, and to stimulate and support critical research activities and a CURE. The Foundation is headquartered in Pasadena, California. For more information, visit http://www.nucdf.org, or call (626) 578-0833.

About Hyperion Therapeutics

Hyperion Therapeutics is a privately held specialty therapeutics company focused on the development of therapies that address critical unmet needs and underserved patient populations in the areas of gastroenterology and hepatology. Hyperion is headquartered in South San Francisco, CA. For additional information, visit: http://www.hyperiontx.com.


'/>"/>
SOURCE Hyperion Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Hyperion Therapeutics Elects Lota Zoth to Board of Directors
2. Hyperion Therapeutics Announces Enrollment of First Patient in Phase 2 Clinical Trial in Patients With Hepatic Encephalopathy
3. Transition Therapeutics Announces First Quarter Fiscal 2009 Financial Results
4. Duska Therapeutics and DSM Pharmaceuticals in Manufacturing Collaboration for PSVT Drug Product
5. Transition Therapeutics to Hold Conference Call on First Quarter Fiscal 2009 Financial Results on Monday, November 10th, at 4:30 P.M. EST
6. Nektar Therapeutics Repurchases $100 Million of Convertible Debt and Reports Third Quarter 2008 Financial Results
7. Cell Therapeutics, Inc. (CTI) Rodman & Renshaw Healthcare Conference Presentation to be Webcast
8. Cornerstone Therapeutics Announces New Board of Directors
9. Orexigen(R) Therapeutics Announces Webcast of Third Quarter Financial Results on November 6, 2008
10. Cornerstone BioPharma Announces Completion of Merger with Critical Therapeutics
11. Cell Therapeutics, Inc. (CTI) Oppenheimer & Co. Healthcare Conference Presentation to be Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... PLAINSBORO, N.J. (PRWEB) , ... ... ... J. Hennessy Associates, Inc. , a full-service health care communications company offering ... integrated digital news resource for practitioners and specialists working in infectious diseases. ...
(Date:2/10/2016)... ... February 10, 2016 , ... As part of its ongoing ... February 2016. Each webinar features a dynamic expert and thoughtful presentation to give ... patients and facilities. Both events are free to attend, but registration is ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... solution, The Guard, to associations of medical professionals throughout the country. The Guard ... security risk assessments, policies and procedures, employee training, regulatory updates, and compliance coaching. ...
(Date:2/10/2016)... ... February 10, 2016 , ... 10 Best Water is excited ... bottled water brand owners that topped the list as a result of their commitment ... The premier brand was Tibet 5100, a top notch water company that specializes in ...
(Date:2/10/2016)... ... ... Ongoing news of the ravages of traumatic brain injury (TBI) among former NFL ... a closer look at cases of TBI being managed by their members. The survey ... aging population, and identifies the challenges associated with their care. , During the week ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... Feb. 10, 2016 CSI Specialty Group (CSI) ... launch of the Specialty Pharmacy Podcast. A free, weekly ... at providing real-world education, discussion and context amongst specialty ... --> The Specialty Pharmacy Podcast, ... CSI Specialty Group Suzette DiMascio, CHE, CMCE, CPC, is ...
(Date:2/10/2016)... WOONSOCKET, R.I. , Feb. 10, 2016  CVS ... vaccines to people living in Santa Clara ... of Meningitis B on the Santa Clara University campus. ... vaccines available to protect patients against the disease. Students ... are encouraged to get vaccinated. In addition, anyone who ...
(Date:2/10/2016)... Feb. 10, 2016  Rich Pharmaceuticals, Inc. (OTC Markets: ... 1-for-100 reverse split of its issued and outstanding shares ... on Thursday, February 11, 2016. The Company,s common stock ... number 76303T308 and temporary ticker symbol "RCHAD". After 20 ... the ticker symbol (RCHA).  --> ...
Breaking Medicine Technology: