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:5/3/2016)... Westminster, CO (PRWEB) , ... May 03, 2016 ... ... analysis , announced the addition of Dr. Nancy Gillett to its Board of ... last position, she served as Corporate Executive Vice President and Chief Scientific Officer. ...
(Date:5/3/2016)... (PRWEB) , ... May 03, 2016 , ... According to ... , for definitive prostate cancer treatment, patients traditionally had two main treatment options: surgery ... plan would be made. , New technology has enabled doctors to administer higher ...
(Date:5/2/2016)... , ... May 02, 2016 , ... ... report on the pre-launch success of their revolutionary, veterinarian-designed product for indoor cats. ... stalk, trap, and play with their food the way nature intended. NoBowls make ...
(Date:4/29/2016)... ... 2016 , ... During a two day program for start-up ... CereScan’s CEO, John Kelley, joined other Denver business leaders in providing business basics ... Denver area business community, shared his top fundamental learnings in building an effective, ...
Breaking Biology Technology:
(Date:3/9/2016)... -- This BCC Research report provides an overview of ... (RNA Seq) market for the years 2015, 2016 and ... data analysis, and services. Use this report ... such as RNA-Sequencing tools and reagents, RNA-Sequencing data analysis, ... segment and forecast their market growth, future trends and ...
(Date:3/3/2016)...  FlexTech, a SEMI Strategic Association Partner, awarded five ... Development, Leadership in Education, and, in a category new ... year of the FLEXI Awards and the winners ... past years . Judging was done on a ... criteria, by a panel of non-affiliated, independent, industry experts. ...
(Date:3/2/2016)... , March 2, 2016 ... of the "Global Biometrics as a ... offering. --> http://www.researchandmarkets.com/research/cmt3hk/global_biometrics ) ... "Global Biometrics as a Service Market 2016-2020" ... --> Research and Markets ( http://www.researchandmarkets.com/research/cmt3hk/global_biometrics ...
Breaking Biology News(10 mins):