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:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample tracking ... Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. ... Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our capacity as ...
(Date:6/23/2016)... 2016  Blueprint Bio, a company dedicated to identifying, ... community, has closed its Series A funding round, according ... "We have received a commitment from Forentis Fund ... to meet our current goals," stated Matthew Nunez ... to complete validation on the current projects in our ...
(Date:6/23/2016)... CA (PRWEB) , ... June 23, 2016 , ... ... software, is exhibiting at the Pennsylvania Convention Center and will showcase its product’s ... conference. ClinCapture will also be presenting a scientific poster on Disrupting Clinical Trials ...
(Date:6/23/2016)...  Amgen (NASDAQ: AMGN ) today announced ... life sciences incubator to accelerate the development of new ... at QB3@953 was created to help high-potential life science ... early stage organizations - access to laboratory infrastructure. ... two "Amgen Golden Ticket" awards, providing each winner with ...
Breaking Biology Technology:
(Date:4/15/2016)... 2016  A new partnership announced today will ... decisions in a fraction of the time it ... high-value life insurance policies to consumers without requiring ... Force Diagnostics, rapid testing (A1C, Cotinine and HIV) ... pressure, weight, pulse, BMI, and activity data) available ...
(Date:4/14/2016)... BioCatch ™, the global ... the appointment of Eyal Goldwerger as CEO. ... Goldwerger,s leadership appointment comes at a time of significant ... of its platform at several of the world,s largest ... unique cognitive and physiological factors, is a winner of ...
(Date:3/31/2016)... , March 31, 2016 ... ) ("LegacyXChange" or the "Company") LegacyXChange is ... users of its soon to be launched online site ... https://www.youtube.com/channel/UCyTLBzmZogV1y2D6bDkBX5g ) will also provide potential shareholders ... of DNA technology to an industry that is notorious ...
Breaking Biology News(10 mins):