Shares of Keryx Biopharmaceuticals (Nasdaq:KERX) got slammed today after the company announced that their cancer drug trial, KRX-0401 (in-licensed by Keryx from AeternaZentaris Inc. (AEZS) in the United States, Canada and Mexico), failed.
Ron Bentsur, Chief Executive Officer of Keryx, stated:
We are all extremely disappointed with the results of the study. We thank the investigators who participated in what we believe was a well-run study, despite the outcome. We will evaluate whether our Phase 3 study of Perifosine in relapsed/refractory multiple myeloma will continue as planned. With approximately $31 million in cash as of March 31, 2012, and a well-controlled burn rate, we plan to focus our resources on the pending completion of the Zerenex (ferric citrate) long-term Phase 3 study for end stage renal disease (ESRD) patients with hyperphosphatemia, expected in the fourth quarter of 2012, and the New Drug Application (NDA) filing for Zerenex which will hopefully follow shortly thereafter.
Take a note on the Mr.Bentsur statement about Zerenex (above). This should be a “life-saver” for the company:
Zerenex (ferric citrate) is an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Zerenex has completed a U.S. Phase 2 clinical program as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, and the Phase 3 clinical program of Zerenex is ongoing under an SPA agreement with the FDA. Zerenex is also in Phase 3 development in Japan by our Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
Zerenex short-term Phase 3 efficacy study was initiated in May 2010, and was completed in November 2010. Zerenex met the primary and key secondary endpoints in the study.
Zerenex long-term Phase 3 safety and efficacy study was initiated in September 2010 and is ongoing.
In addition, Zerenex is in Phase 3 development in Japan by our Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.
KERX stock traded almost 10X of its 10day average volume as of 11 a.m. EST
Keryx Biopharmaceuticals, Inc.
750 Lexington Ave. – 20th Floor
New York, NY 10022
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer.