Navigation Links
Keryx Biopharmaceuticals Announces Positive Final Data from Zerenex™ Short-Term Phase 3 Study
Date:4/28/2011

oint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).

Additional efficacy results are as follows: Mean Serum Phosphorus (mg/dL) ITT (n=146)1g/Day
(n=50)6g/Day
(n=51)8g/Day
(n=45)Baseline (End of Washout)

7.3

7.6

7.5Day 28/LOCF* (End of Treatment)

7.4

5.6

5.3Change from Baseline at Day 28

P-Value

0.1-2.0

<0.0001

-2.2

<0.0001% Change from Baseline at Day 28

0.5%

-25.7%

-29.6%* Last observation carried forward was used for missing data.

Additional highlights from Dr. Goldfarb's presentation on Zerenex are as follows:

  • Statistically significant dose response increase in serum bicarbonate suggests potential to address metabolic acidosis
  • Statistically significant dose response reduction in calcium x phosphorus product
  • Modest upward trends in Ferritin and TSAT in 6 grams/day and 8 grams/day dose groups further supports theory that Zerenex could reduce the need for intravenous iron and erythropoiesis-stimulating agent (ESA) use
  • Zerenex appeared to be safe and well-tolerated in the study
  • GI adverse events were mostly mild and transient in nature
  • No SAEs were deemed to be drug-related by the Data Safety Monitoring Committee

  • Dr. Goldfarb concluded that Zerenex has the potential to become a viable alternative to the currently approved phosphate binders used to treat ESRD patients.

    Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are encouraged by the final efficacy and safety data from the Phase 3 short term study presented earlier today, which confirm the top-line data previously reported."  Mr. Bentsur continued, "We thank Dr. Goldfarb for his time and effort in preparing for and delivering this morning's presentation."

    In accordance with the Company's Special Pr
    '/>"/>

    SOURCE Keryx Biopharmaceuticals, Inc.
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4

    Related biology technology :

    1. Keryx Biopharmaceuticals to Present at 13th Annual BIO CEO and Investor Conference
    2. Keryx Biopharmaceuticals to Present at 29th Annual J.P. Morgan Healthcare Conference
    3. Keryx Biopharmaceuticals to Present at Lazard Capital Markets 7th Annual Healthcare Conference
    4. Keryx Biopharmaceuticals to Present at the UBS 2010 Global Life Sciences Conference
    5. Æterna Zentaris Partner Keryx Announces Special Protocol Assessment Agreement with FDA for Phase 3 Trial of Perifosine (KRX-0401) in the Treatment of Patients with Refractory Metastatic Colorectal Cancer
    6. Æterna Zentaris Partner Keryx Announces Positive Phase 2 Results for Perifosine as a Single Agent for the Treatment of Advanced Waldenstroms Macroglobulinemia
    7. Æterna Zentaris Partner Keryx Reports a Statistically Significant Benefit in Survival from Updated Results of a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Perifosine (KRX-0401) in the Treatment of Advanced Metastatic Colon Cancer
    8. AEterna Zentaris Partner, Keryx, Initiates Phase 3 Registration Trial with Perifosine (KRX-0401) for the Treatment of Patients with Advanced Multiple Myeloma
    9. AEterna Zentaris Partner, Keryx, Reports Updated Phase 1/2 Data, Including New Survival Data, on Perifosine (KRX-0401) in the Treatment of Advanced Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
    10. AEterna Zentaris Partner, Keryx Biopharmaceuticals, Receives Orphan-Drug Designation for Perifosine (KRX-0401) for the Treatment of Multiple Myeloma
    11. Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:2/27/2015)... February 27, 2015 FamilyFarms Group is ... Manager of State Line Farms, received the 2015 Tomorrow’s ... producer, under the age of 35, who has demonstrated ... an honor to win the Tomorrow's Top Producer Horizon ... won the Top Producer Award and learning from their ...
    (Date:2/27/2015)...  Steep Hill, the industry leader in cannabis testing ... open a full service medical cannabis quality assurance laboratory ... advanced scientific tools and methodology to the state, for ... currently the only laboratory licensed by the New Mexico ... in order to meet the recently adopted regulatory requirements ...
    (Date:2/26/2015)... NEW YORK , Feb. 26, 2015 ... commenced Factual Stock Report coverage on MabVax Therapeutics ... Inc. (MBVX) is a clinical stage biotechnology company focused ... address unmet medical needs in the treatment of cancer. ... products based on the protective immune responses generated by ...
    (Date:2/26/2015)... VIEW, Calif. , Feb. 26, 2015  23andMe, ... of Kate Black as Privacy Officer and ... federal, and state privacy laws as well as health ... regulatory team, she will be responsible for reviewing, updating ... customers in the U.S. and abroad. She joined the ...
    Breaking Biology Technology:Matt Sims Receives the 2015 Tomorrow’s Top Producer Horizon Award 2Steep Hill First to Receive Provisional Approval to Establish Laboratory Services for Cannabis Testing in State of New Mexico 2S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 2S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 3S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 4S&P Capital IQ Initiates Coverage on MabVax Therapeutics Holdings Inc. in S&P Capital IQ Factual Stock Reports 523andMe Appoints Kate Black as Privacy Officer and Corporate Counsel 2
    ... 11 PAREXEL International Corporation (Nasdaq: PRXL ) today ... Fiscal Year 2010 ended December 31, 2009, and for the ... Company,s updated financial guidance takes into account the projected impact ... for the amount and timing of a previously announced restructuring ...
    ... BOCA RATON, Fla., Jan. 11 Stem Cell Assurance, ... cell cosmetic and therapeutic procedures for individual clients, today ... its elite physician network. Stem Cell Assurance utilizes ... your body,s own regenerative cells to produce natural results, ...
    ... , ... Performagene™•LIVESTOCK Enables Easier, More Economical Genetic Testing to Facilitate Breed Improvements. Producers, breed ... and scalable collection device that will positively impact the industry’s ability to accelerate ... ...
    Cached Biology Technology:PAREXEL Issues Updated Financial And Operational Information 2PAREXEL Issues Updated Financial And Operational Information 3PAREXEL Issues Updated Financial And Operational Information 4PAREXEL Issues Updated Financial And Operational Information 5Stem Cell Assurance Unveils Physician Network Offering Regenerative Cell Cosmetic and Reconstructive Applications 2Stem Cell Assurance Unveils Physician Network Offering Regenerative Cell Cosmetic and Reconstructive Applications 3DNA Genotek Launches New Sample Collection Product to Accelerate Livestock Genetic Testing 2DNA Genotek Launches New Sample Collection Product to Accelerate Livestock Genetic Testing 3DNA Genotek Launches New Sample Collection Product to Accelerate Livestock Genetic Testing 4
    (Date:2/5/2015)... Calif. , Jan. 27, 2015 /PRNewswire/ ... provider of globally deployed, innovative test solutions ... announced the delivery of its TS-323 ... Space Systems Company (LMSSC). GENASYS is a ... demands of mission-critical applications that require performance ...
    (Date:2/5/2015)... JOLLA, Calif. , Jan. 30, 2015  It ... the great power and potential for genomic science as ... aid in disease prevention and treatment.  I was honored ... potential new, government-funded precision medicine program. ... advancing the science of genomics—from the first sequenced genome ...
    (Date:1/22/2015)... the leading source of biometrics industry news, interviews and thought ... "When we launched FindBiometrics 12 years ago the industry ... and CEO of FindBiometrics. "Now it,s maturing very quickly. More ... on a very broad scale.  We are known for providing ...
    Breaking Biology News(10 mins):Marvin Test Solutions' GENASYS Platform Advances Mission-Critical Aerospace Production Test 2Marvin Test Solutions' GENASYS Platform Advances Mission-Critical Aerospace Production Test 3Marvin Test Solutions' GENASYS Platform Advances Mission-Critical Aerospace Production Test 4J. Craig Venter, Ph.D., Co-Founder and CEO, Human Longevity, Inc. (HLI) Participates in White House Precision Medicine Event 2Identity Industry Leading Publication Debuts New Look As Biometrics Hit Mainstream 2
    ... New research suggests eating vegetables gives you a healthy tan. The ... showed that eating a healthy diet rich in fruit and vegetables ... The research, which showed that instead of heading for the sun ... and tomatoes, has been published in the journal Evolution and ...
    ... in which polymer membranes with molecular-sized channels ... or desalinating sea water, among many other functions. ... can be readily fabricated in bulk quantities. A ... road has now been successfully demonstrated. Researchers ...
    ... been named fellows of the American Association for the ... society. The rank of fellow is bestowed upon ... socially distinguished efforts to advance science or its applications. ... Of the Washington University honorees, two are from the ...
    Cached Biology News:Looking good on greens 2Polymer membranes with molecular-sized channels that assemble themselves 2Polymer membranes with molecular-sized channels that assemble themselves 33 WUSTL faculty named AAAS Fellows 23 WUSTL faculty named AAAS Fellows 3