Navigation Links
NephroGenex Announces the Successful Completion of PYR-210
Date:11/7/2011

RESEARCH TRIANGLE PARK, N.C., Nov. 7, 2011 /PRNewswire/ -- NephroGenex, Inc., a privately held drug development company, today announced the completion of PYR-210, a Phase 2b trial that studied the safety and efficacy of its lead drug candidate Pyridorin™ (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt nephropathy. 

PYR-210 evaluated two doses of Pyridorin™ against placebo in 317 patients over a one year treatment period. Patients enrolled in the trial were type 2 diabetic patients with elevated serum creatinine (SCr) levels and significant proteinuria, and were on standard of care which included adequate blood pressure control and a stable regimen of ACEi/ARB therapy. Efficacy was evaluated based on a 12 month change in SCr from baseline.    

As reported in the current online issue of the Journal of the American Society of Nephrology, Pyridorin™ was well tolerated and has a benign safety profile. Pyridorin™ did not produce a significant treatment effect in the entire patient population treated; however, in patients with less severe disease (i.e. baseline SCr values less than 1.9 mg/dL), Pyridorin™ did produce a treatment effect greater than 50% relative to placebo that is statistically significant. 

Patients treated with Pyridorin™ who were on previously established standard of care at screening, with a baseline SCr of up to 3 mg/dL, which includes patients with both mild and moderate levels of disease, showed a highly significant 57% treatment effect for the 300 mg arm (P = 0.009; n=64) and 45% for the 150 mg arm (P=0.045; n=62) relative to placebo. Pyridorin also slowed the progression of cystatin C and caused a reduction in urinary TGF beta in this patient population.

Approximately 70 to 80% of diabetic overt nephropathy patients have SCr values less than 2 mg/dL and approximately 80 to 90% have SCr values less than 3 mg/dL. Thus, Pyridorin™ therapy has demonstrated efficacy in the large majority of diabetic patients with overt nephropathy.  

In two previous Phase 2a trials, Pyridorin™ therapy demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy as measured by the change in serum creatinine over a six month treatment period. Pyridorin therapy also demonstrated a reduction in urinary TGF beta, an important marker of glomerulosclerosis and tubulointerstitial fibrogenesis.

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 medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... 20, 2017  RXi Pharmaceuticals Corporation (NASDAQ: RXII), ... address significant unmet medical needs, today announced that ... consumer product development program, based on its proprietary ... Investigative Dermatology (SID) 76 th Annual Meeting.  ... the sciences relevant to skin health and disease ...
(Date:4/20/2017)... --  ZappRx, Inc ., a digital health company focused on ... it closed $25 million in Series B funding led by ... Seattle that is part of a ... B round included participation from SR One , who ... (formerly Google Ventures). As part of the financing, ...
(Date:4/20/2017)... , April 20, 2017 Eyevensys, ... the first non-viral gene expression technology that enables the ... eye to address a wide range of ophthalmic diseases, ... and Healthcare products Regulatory Agency (MHRA) to advance its ... ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... Somnoware, a leading ... Word(TM) Online(TM), which enables sleep physicians to create and edit their interpretation reports. ... and provides a familiar interface that does not require additional training to use. ...
(Date:4/28/2017)... Grants Pass, OR (PRWEB) , ... April 28, ... ... Adetutu Ijose, http://www.foodsthathealdaily.com , http://www.wiredlifesolutions.com , “Computers are everywhere and ... Kleyne Hour Power of Water, Global Climate Change and Your Health on Voice ...
(Date:4/28/2017)... ... April 28, 2017 , ... The Texas Cord Blood ... to the labor and delivery team at Women’s Hospital at Renaissance in Edinburg for ... birth at the hospital and decide to donate. , “Women’s Hospital at Renaissance ...
(Date:4/28/2017)... ... ... Pastor and Overseer at The House of Yahweh in Abilene, Texas, has published a new ... not. Yisrayl says with so many titles and names for the Creator, it’s hard ... a little Scripture, backed with a lot of research, the truth is undeniable. , ...
(Date:4/28/2017)... , ... April 28, 2017 , ... NuevaCare, a leading ... diverse as Millbrae, Burlingame, and Palo Alto, is proud to announce information upgrades to ... to bookmark and read organized content on topics such as home care (generally) as ...
Breaking Medicine News(10 mins):