KERX up 20% or so -
Keryx Announces Results of Data Safety Monitoring Committee and Collaborative Study Group (CSG) Review of First Interim Analysis From Phase II/III Clinical Program for KRX-101 (Oral Sulodexide) for the Treatment of Diabetic Nephropathy
Wednesday January 5, 8:40 am ET
No Safety Concerns Raised with Either the 200mg or 400mg Dose
The CSG Recommends that the Company Proceed to Phase III As Planned
NEW YORK, Jan. 5 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals (Nasdaq: KERX - News) today announced that the Collaborative Study Group (CSG) has recommended that the Company proceed to the Phase III portion of its Phase II/III clinical program of KRX-101 for the treatment of diabetic nephropathy, as planned. This recommendation is based on the completion, by an independent Data Safety Monitoring Committee (DSMC) on January 4th, 2005, of a safety evaluation of the first interim analysis from the approximately 150-patient, randomized, double-blind, placebo-controlled Phase II clinical trial of KRX- 101, and an efficacy assessment of the same data set conducted by the CSG.
Pursuant to this recommendation, and subject to Keryx's successful finalization of its clinical plan with the FDA, Keryx expects to commence its pivotal program, including both Phase III and Phase IV studies for KRX-101, within approximately the next three months. The clinical plan as discussed with the FDA for KRX-101 consists of a single Phase III trial in patients with microalbuminuria to support NDA approval under Subpart H (accelerated approval), based on the surrogate marker of regression of microalbuminuria. The completion of the Phase III is to be followed by the completion of a Phase IV confirmatory study in patients with overt nephropathy (macroalbuminuria) that will measure clinical outcomes. As part of its commitment to the FDA, Keryx plans to commence the Phase IV trial at approximately the same time as the start of the Phase III trial.
The KRX-101 Phase II/III clinical program is being conducted by the CSG, the world's largest standing renal clinical trial group, whose execution of the ACE Inhibition trial in Type 1 Diabetic Nephropathy and the trial of Irbesartan (an A2 Receptor Blocker or ARB) in Type 2 Diabetic Nephropathy (I.D.N.T.) both led to FDA approval and the recommendation of these agents as standards of care by the American Diabetes Association.
The DSMC issued the following statement to the Company: "We have carefully examined the safety data collected through December 8, 2004, and serious adverse event data collected through December 28, 2004. We have no concerns that would alter conduct or interpretation of the study. The study should be continued to completion as planned, based on these interim data. The investigators should be commended for doing an outstanding job in study design, recruitment, and conduct to this point."
The leadership of the CSG has commented to the Company as follows: "The CSG recommends that Keryx should proceed with the Phase III and Phase IV studies of KRX-101 in diabetic kidney disease with micro and macro albuminuria, respectively, as planned. We believe, based on the interim data, that a valid pivotal Phase III study can be conducted using the protocol as currently constructed."
"We look forward to the initiation of the pivotal part of the program," said Michael S. Weiss, Chairman and Chief Executive Officer of Keryx Biopharmaceuticals, who added, "We are also very excited and grateful to continue working with the CSG, whose unprecedented track-record and breadth of knowledge in diabetic nephropathy have been invaluable to this clinical program. We also sincerely thank the members of the DSMC for their diligence and professionalism, and the investigators for their on-going dedication to this clinical program."
About the KRX-101 Phase II/III Clinical Program
The Phase II study reported on today is a multi-center clinical trial, representing the Phase II portion of the Company's Phase II/III clinical program for the treatment of diabetic nephropathy. This Phase II clinical trial is a randomized, double-blind, placebo-controlled study, comparing two doses (200mg and 400mg daily) of KRX-101, the Company's lead drug candidate, versus placebo. Approximately 150 patients have been enrolled into this clinical trial.
The Phase II/III program is designed to assess the safety and efficacy of KRX-101 in patients with diabetes who continue to have persistent microalbuminuria despite treatment with maximum approved doses of standard-of- care therapy (ACE inhibitors or A2 Receptor Blockers (ARBs)). In this study, patients are being treated for six months and then followed for an additional two months off-therapy. All patients in the study population will continue to receive maximum approved doses of ACEs or ARBs during the treatment and follow-up periods. The designs of the Phase II and Phase III portions of the program are expected to be substantially the same.
The entire Phase II/III program is expected to enroll between approximately 750 and 1,000 patients... |
