Navigation Links
NephroGenex Reaches Agreement with the FDA on a Subpart H Phase 3 Program for Pyridorin™
Date:11/7/2011

RESEARCH TRIANGLE PARK, N.C., Nov. 7, 2011 /PRNewswire/ -- NephroGenex, Inc., a privately held drug development company, today announced that it has reached an agreement with the FDA on the design of a new Phase 3 Subpart H program that evaluates Pyridorin™ in diabetic nephropathy patients.  This Subpart H program uses a novel surrogate endpoint based on an increase in serum creatinine (SCr), and provides for an accelerated regulatory pathway to approval.

The new surrogate endpoint was determined from a comprehensive analysis of prior large clinical trials in diabetic nephropathy patients that demonstrated a highly significant relationship between increases in SCr and the future progression of patients to end stage renal disease (ESRD).

In the Pyridorin™ Phase 3 Subpart H program, the FDA has agreed that approval will be based on a new surrogate endpoint that includes SCr changes after one year that predict progression to ESRD.  These patients will subsequently be followed to confirm the clinical benefit of Pyridorin™ in delaying progression to ESRD.  The patient population for the study will be type 2 diabetic patients with overt nephropathy who are on an established standard of care consisting of adequate blood pressure control and a stable regimen of ACEi/ARB therapy.

Diabetic kidney disease afflicts approximately one-third of all diabetics and is the major cause of ESRD, which is a significant component of healthcare expenditures.  Mortality rates for ESRD patients can reach 20% annually.  Pyridorin™ has been awarded Fast Track status by the FDA due to the unmet medical need of patients with this life-threatening disease.

About NephroGenex, Inc.

NephroGenex (www.nephrogenex.com) is a drug development company focusing on kidney disease.  The Company is developing Pyridorin™ (pyridoxamine dihydrochloride) as a treatment to slow the progression of diabetic kidney disease.  Pyridorin™ is one of only a few drug candidates in advanced clinical trials for diabetic kidney disease, and possesses a distinctly new mechanism of action which targets an important diabetes-induced underlying cause of the disease. 

Contact:
J. Wesley Fox, Ph.D.
President and CEO
NephroGenex, Inc.
(609) 986-1780 phone  
(609) 275-5610 fax
www.nephrogenex.com  
Email: fox@nephrogenex.com  


'/>"/>
SOURCE NephroGenex, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Proactive Brain Health Critical as Americans Life Expectancy Reaches All Time High
2. Aperion Biologics Reaches Midpoint of Enrollment in Z-Lig™ Anterior Cruciate Ligament Reconstruction Medical Device Performance Trial
3. Rules-Based Medicine Reaches a Significant Milestone in Companion Diagnostic Program With Roche
4. Biomerix Corporation Reaches European Distribution Agreement with Cellon S.A.
5. Dynamic Ventures Corp. Reaches An Agreement in Principle with NOVA Home Loans
6. BioSoteria Drug Safety Newsletter Reaches Milestone
7. Oncolytics Biotech(R) Inc. Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers
8. Poniard Pharmaceuticals Announces Pivotal Phase 3 SPEAR Trial Evaluating Picoplatin in Small Cell Lung Cancer Reaches 320th Event Target
9. Campaign to Increase the Awareness and Understanding of Lou Gehrigs Disease Reaches 22 U.S. States
10. National Ergonomics Conference and Expo Reaches 94% Exhibitor Renewal Rate
11. Perceptive Informatics Reaches Key Milestone Marking 10 Million IVRS Interactions In Support of Clinical Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... ... 25, 2016 , ... The American Medical Informatics Association (AMIA) ... National Coordinator for Health IT (ONC) outlining a measurement approach to interoperability that ... when and where it was needed. The organization of health informatics professionals said ...
(Date:5/25/2016)... ... May 25, 2016 , ... WEDI, the nation’s leading authority on ... that Charles W. Stellar has been named by the WEDI Board of Directors as ... As an executive leader with more than 35 years of experience in healthcare, association ...
(Date:5/25/2016)... ... May 25, 2016 , ... Biohaven ... Administration (FDA) has granted the company’s orphan drug designation request covering BHV-4157 for ... designation granted by the FDA. , Spinocerebellar ataxia is a rare, debilitating ...
(Date:5/24/2016)... TEL AVIV, Israel , May 24, 2016   ... on providing physicians with artificial intelligence, real-time decision support tools ... selected to present at the 2016 Israeli Advanced Technology Industries ... part of Israel,s 15th National Life ... to 26th at the David Intercontinental Hotel in ...
Breaking Biology Technology:
(Date:3/23/2016)... Massachusetts , March 23, 2016 /PRNewswire/ ... im Interesse erhöhter Sicherheit Gesichts- und Stimmerkennung ... Xura, Inc. (NASDAQ: MESG ), ... bekannt, dass das Unternehmen mit SpeechPro zusammenarbeitet, ... aus der Finanzdienstleistungsbranche, wird die Möglichkeit angeboten, ...
(Date:3/22/2016)... PROVO and SANDY, Utah ... (NSO), which operates the highest sample volume laboratory in ... Tute Genomics and UNIConnect, leaders in clinical sequencing informatics ... the launch of a project to establish the informatics ... NSO has been contracted by the ...
(Date:3/18/2016)... 18, 2016 --> ... ICT, Manned & Unmanned Vehicles, Physical infrastructure and Perimeter Surveillance ... in the border security market and the continuing migration crisis ... Europe has led visiongain to publish this ... --> defence & security companies in the ...
Breaking Biology News(10 mins):