Keryx Biopharmaceuticals Announces Termination of SUN-MACRO Phase 4 Trial
NEW YORK, March 27, 2008 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. announced today that following a Drug Safety and Monitoring Committee (DSMC) review of the SUN-MACRO Phase 4 trial of Sulonex(TM) (sulodexide oral gelcap), the Company has decided to terminate the study and cease further development of Sulonex.
The Company previously announced via conference call on March 10th that the trial had been suspended pending an interim analysis, following which the Company would make a decision regarding whether the trial ought to be continued or terminated.
Based on a review of the available proteinuria data, Sulonex did not appear to be different than placebo. The study was not terminated by the DSMC for a safety problem or safety signal.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, or ESRD. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401, which is currently in Phase 2 clinical development for multiple tumor types, is expected to move into a Phase 3 clinical program in 2008. The Company also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
As the Company has indicated in its public filings, among other things, clinical trials have a high risk of failure. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after achieving what appeared to be promising results in earlier trials.
Furthermore, as indicated in previous filings, interim results of preclinical or clinical studies do not necessarily predict their final results, and acceptable results in early studies might not be obtained in later studies. Drug candidates in the later stages of clinical development may fail to show the desired safety and efficacy traits despite positive results in initial clinical testing.
Additionally, as indicated in previous filings, there can be no assurance that the results from the Sulonex Phase 3 and/or Phase 4 study will track the data from the pilot Collaborative Study Group Phase 2 study or the DiNAS Phase 2 study. Results from these earlier Sulonex studies may not be indicative of results from future clinical trials.
Some of the statements included in this press release anticipating future clinical and business prospects may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully adjust our strategy and reduce our operating expenses in order to properly support the trials of our other drug candidates; our ability to complete cost- effective clinical trials or meet anticipated development timelines for the other drug candidates in our pipeline, including Zerenex and KRX-0401; or other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT: Lauren Fischer Director - Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail:firstname.lastname@example.org
CONTACT: Lauren Fischer, Director, Investor Relations, KeryxBiopharmaceuticals, Inc., +1-212-531-5965, email@example.com
Web site: http://www.keryx.com/
Ticker Symbol: (NASDAQ-NMS:KERX)
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Posted: March 2008