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:2/11/2016)... ... February 11, 2016 , ... ... cell treatment clinic in Quito, Ecuador. The new facility will provide advanced protocols ... patients from around the world. , The new GSCG clinic is headed ...
(Date:2/10/2016)... 10, 2016  The Maryland House of Delegates and ... that University of Maryland School of Medicine Dean ... of Maryland Medical System President and CEO Robert ... the highest honor given to the public by the ... Dean Reece and Mr. Chrencik for their contributions ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... that it has joined the Human Vaccines Project, a public-private partnership to ... cancer. , The Human Vaccines Project brings together leading pharmaceutical and ...
(Date:2/10/2016)... 10, 2016  Matchbook, Inc., a company specializing ... biotech companies, announced today the appointment of ... Jim brings nearly 25 years of experience in ... spent nearly two decades in executive level roles ... at Genzyme and, most recently headed global logistics ...
Breaking Biology Technology:
(Date:1/20/2016)... 20, 2016 A market that just keeps ... from the explosion in genomics knowledge. Learn all about ... A range of dynamic trends are pushing market growth ... medicine - pharmacogenomics - pathogen evolution - next generation ... - greater understanding of the role of genetic material ...
(Date:1/15/2016)... Rico , Jan. 15, 2016 Recent ... and small to find new ways to ensure data ... iOS and Android that ... on biometrics, transforming it into a hardware authorization token. ... users swipe their fingerprint on their KodeKey enabled device ...
(Date:1/11/2016)... , Jan. 11, 2016  higi, the leading ... 10,000 retail locations, web and mobile, today announced ... million from existing investors. --> ... devoted to further innovate higi,s health platform – ... web portal – including expanding services and programs ...
Breaking Biology News(10 mins):