Navigation Links
Keryx Biopharmaceuticals Completes SUN-MICRO Phase 3 Pivotal Trial
Date:2/11/2008

NEW YORK, Feb. 11 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals announced today that the last subject randomized into the SUN-Micro Phase 3 clinical trial has completed their scheduled 8 month visit. This milestone officially marks the completion of this pivotal clinical trial of its investigational drug Sulonex(TM) (sulodexide oral gelcap) in the treatment of subjects with type 2 diabetes and persistent microalbuminuria despite treatment with the maximum approved or tolerated dose of either an Angiotensin Converting Enzyme inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB). This randomized, double-blind, placebo-controlled study enrolled 1,056 subjects at over 150 sites worldwide.

The Company anticipates being able to report top-line results from this study before the end of March 2008, and expects that the Collaborative Study Group will make a comprehensive scientific presentation of the data at a medical conference in the 2nd or 3rd quarter. The Company is targeting an NDA filing before year end.

"The completion of the Sulonex Phase 3 clinical program is an important and significant milestone for Keryx," stated Michael S. Weiss, Chairman and CEO of the Company, who continued, "We recognize and are grateful for the dedication, diligence and compliance exhibited by the Collaborative Study Group and the more than 1,000 patients who participated in what is considered to be the largest ever randomized study for type 2 diabetic patients with persistent microalbuminuria."

Commenting on the news, Edmund J. Lewis, MD, co-Principal Investigator of the Phase 3 Study remarked, "We would like to commend both our Investigators and their patients for their level of commitment towards the completion of this pivotal 8-month study, marking the culmination of critical research in a disease area for which there has not been a novel treatment option in almost 15 years. We look forward to assembling and analyzing the data from this study."

A
'/>"/>

SOURCE Keryx Biopharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
2. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
3. Keryx Biopharmaceuticals to Present at William Blair & Company Small-Cap Growth Stock Conference
4. Morria Biopharmaceuticals Plc Announces Preliminary Safety and Tolerability Results From Its Phase I Clinical Study of MRX-4 in Allergic Rhinitis Patients
5. XTL Biopharmaceuticals Presents Data Regarding its Hepatitis C Virus Small Molecule Program at Hep Dart 2007 - an International Scientific Conference on Viral Hepatitis
6. Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B
7. Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months
8. Morria Biopharmaceuticals Plc Initiates Phase I Clinical Study of MRX-4 in Allergic Rhinitis
9. Nabi Biopharmaceuticals Announces Continued Positive NicVAX Phase 2b Data at Nine Months
10. Nabi Biopharmaceuticals Announces Second Quarter 2007 Financial Results
11. WallSt.net (www.wallst.net) Updates the Investment Community Through an All-New Interview With RegeneRx Biopharmaceuticals CEO
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... , Jan. 23, 2015  Northwest Biotherapeutics, Inc. (NASDAQ: ... immune therapies for operable and inoperable solid tumor cancers, announced ... the 7 th Annual Phacilitate Immunotherapy Forum in ... at Phacilitate will take place on January 26 at 10:30 ...
(Date:1/23/2015)... , Jan. 23, 2015 More than a third ... quarter of those with private insurance, filled a prescription for ... a report in this week,s Morbidity and Mortality Weekly Report ... care providers to treat moderate to severe pain.  They are ...
(Date:1/23/2015)... 2015 /PRNewswire/-- Harwood Feffer LLP ( www.hfesq.com ) is investigating ... Inc. ("Advaxis" or the "Company") (NASDAQ: ADXS ... duties to shareholders. On January 21, 2015, ... that Advaxis had misrepresented the clinical data for its ...
Breaking Medicine Technology:NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 2NW Bio To Present At The 7th Annual Phacilitate Immunotherapy Forum 3Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3Harwood Feffer LLP Announces Investigation of Advaxis, Inc. 2
(Date:1/23/2015)... 2015 Hastings and Hastings, a law firm ... record number of legal representation client review requests for slip ... a steady rise in the number of slip and fall ... throughout the Valley. With that said, a large number of ... an experienced law firm. Hastings and Hastings is a personal ...
(Date:1/22/2015)... 22, 2015 The City of West Hollywood hosted ... to commemorate the 42nd anniversary of the Supreme Court decision Roe ... been 42 years since the Roe vs. Wade decision and the ... present as ever,” said City of West Hollywood Councilmember Abbe Land. ...
(Date:1/22/2015)... The Incredible Bulk is a revolutionary method put together ... by up to 30lbs in less than 12 weeks without ... Stevenson, prompting an investigative review. , “Our Incredible Bulk ... formula that allows the body to pack on a massive ...
(Date:1/22/2015)... Florida (PRWEB) January 22, 2015 Juvent ... today at the 2015 PGA Merchandise Show to bestow ... and incredible female amateur golfer, Arlene McKitrick. The award ... female amateur golf tournament win. She won her first ...
(Date:1/22/2015)... January 22, 2015 Carinsurancesavings.biz has released a ... death and dismemberment insurance . , Purchasing an accidental ... be very advantageous. This type of rider provides benefits if ... can be considered a lesser form of life insurance. ...
Breaking Medicine News(10 mins):Health News:Hastings and Hastings Reports a Record Number of Client Review Requests for Slip and Fall Accidents in 2014 2Health News:The Incredible Bulk: Review Examining Ben Pakulski’s Brand New Bulking Muscle Building Diet Program Released 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2
... are becoming common everywhere. Only last fortnight it was reported ... 15 ft during a joyride and sustained grievous injuries in ... ,But for a tree branch which checked her ... first aid facilities available, it was reported. ,Now ...
... with Delmont Laboratory to introduce its immunotherapeutic vaccine Staphage ... to this initial agreement, Delmont Laboratory will supply bulk ... the final packaging in China. ,CBPC will ... to be signed. This product requires a clinical study ...
... fill their prescriptions while traveling abroad need to be cautious ... the AAPS National Biotechnology Conference. ,Unlike approved ... internationally. Therefore, consumers should not assume that a branded product ... the same or similar brand name in other counties. ...
... seven billion dollar (5.2 billion euro) negligence suit against ... as the US giant demanded the charges be ... early setback when the court rejected a request to ... Babs Kwewumi adjourned the trial to July 20. ...
... announces that it has completed its acquisition of ... for approximately $600 million on April 4, 2007. ... owns the patents for Electrochemiluminescence (ECL) technology and ... diagnostics field into new market segments such as ...
... called the world's first prototype of an artificial hand with ... up a raw egg. ,Squse, a Kyoto-based ... 400-gramme (14 ounce) hand with five human-sized fingers with artificial ... ,"So far, robots have an image of helping people do ...
Cached Medicine News:Health News:Girls Feet Severed in Amusement Park Accident 2Health News:Nigeria Launches Seven Billion Dollar Case Against Pfizer 2Health News:Nigeria Launches Seven Billion Dollar Case Against Pfizer 3
... Webster is the source for a complete ... catheters for left-sided mapping - all with ... come to expect from the leader in ... sinus diagnostic catheters are specifically designed and ...
4Fr, 5Fr & 6Fr diagnostic electrophysiology catheters with fixed curves....
... Mennen Medical offers patient monitoring ... high acuity and medium acuity monitoring. ... premier monitoring product. The Enmove ... monitoring solution to complement the Envoy. ...
... Advanced engineering, rapid acquisition of ... make it the most accurate autorefractor ... inch High Quality Monitor allows for ... readings are taken as soon as ...
Medicine Products: