Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 ... ( No Safety Co...)

Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data

Date:12/5/2007

No Safety Concerns Raised

Sulodexide Phase 3 study to continue without modification

NEW YORK, Dec. 5 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals (Nasdaq: KERX) today announced that the Independent Data Safety Monitoring Committee (DSMC) responsible for monitoring Sulonex(TM) (sulodexide oral gelcaps), the Company's lead drug candidate under development as a treatment for diabetic nephropathy, recently met to evaluate the data from the ongoing Phase 3 trial. Following a complete review of all available safety and efficacy data, the DSMC found no cogent reason to recommend alteration or termination of the Phase 3 trial. The DSMC raised no safety concerns regarding Sulonex or the trial. As planned, no review was conducted of the safety and efficacy data from the Phase 4 trial during this meeting.

Prior to this most recent meeting, the DSMC had previously convened in November 2006, in March 2007 and in August 2007 to review data from the Phase 3 and Phase 4 studies. At each of these meetings the DSMC raised no safety concerns.

On June 18, 2007, the Company announced the completion of patient randomizations into the Phase 3 portion of the clinical registration program. The Company anticipates that the last patient will complete the active treatment period in mid-December 2007 and the two month off-treatment period in mid-February 2008.

ABOUT THE SULONEX(TM) PHASE 3 and PHASE 4 CLINICAL PROGRAM

Sulonex is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food & Drug Administration. These trials are being conducted by the Collaborative Study Group, the world's largest standing renal clinical trials group. '/>"/>

0

GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
2. Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
3. Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term Safety
4. Five-Year Data From Taxus II Clinical Trial Highlights Safety and Efficacy of Taxus(R) Stent Compared to Bare-Metal Stent
5. Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent
6. Iomai Launches Phase 1/2 Safety Study of Dose-Sparing Patch for Use With Pandemic Influenza Vaccine
7. R7128 Demonstrates Safety and Potent Antiviral Activity in HCV-Infected Patients
8. Ortho Biotech Reiterates Confidence in PROCRIT(R) (Epoetin alfa) Safety and Efficacy When Used According to Label
9. New Phase 3 Study in Treatment-Naive Adults with HIV Evaluates Efficacy and Safety of Once-Daily PREZISTA(TM)/ritonavir vs. KALETRA(R) as Part of HIV Combination Therapy
10. New Data From Large Safety Analysis of MYCAMINE Shows Favorable Clinical Safety Profile
11. Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

Post Your Comments:

Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 ...( No Safety Co...),Health