Shares of Canadian drug maker Aeterna Zentaris Inc. (AEZS, AEZ.TO) and its North American licensee partner Keryx Biopharmaceuticals, Inc. (KERX) lost more than half their value in pre-market activity Monday, after the companies said that a late-stage study of their colorectal cancer drug candidate missed its primary goal of improving overall survival.
In the last one month alone, shares of Keryx had gained over 60 percent as investors eagerly awaited the results of this phase 3 clinical trial, dubbed X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment).
In the trial, Keryx evaluated perifosine (KRX-0401) + Roche's capecitabine (Xeloda) in patients with refractory advanced colorectal cancer versus capecitabine + placebo.
The trial, conducted on 468 patients at sixty-five U.S. sites, was pursuant to a Special Protocol Assessment agreement with the FDA.
Perifosine is an alkylphospholipid that works by blocking signaling pathways that control cell survival, causing cell death. Aeterna, a late-stage drug development company specialized in oncology and endocrine therapy, licensed the rights to this compound to Keryx for North America, Yakult Honsha for Japan, Handok for Korea and Hikma for the Middle East and North Africa.
Colorectal cancer is the third most common form of cancer diagnosed in the U.S. The approved drugs for patients with metastatic colorectal cancer are Roche's Xeloda and Avastin; Pharmacia & Upjohn's Camptosar; Sanofi-Aventis' Eloxatin; Merck KgaA's Erbitux and Amgen Inc.'s Vectibix. Depending on the stage of the cancer, two or more of these types of treatment may be combined at the same time or used after one another.
Noting that all are extremely disappointed with the study results, Keryx's Chief Executive Officer Ron Bentsur said the company will evaluate whether its late-stage study of the same drug in relapsed/refractory multiple myeloma will continue as planned.
Keryx, which had an accumulated deficit of $369.9 million as of December 31, 2011, is developing therapies for life-threatening diseases and its product pipeline include, apart from perifosine, Zerenex (ferric citrate) an oral, iron-based compound.
The long-term, phase 3 study of Zerenex is ongoing and is expected to be completed in the fourth quarter of 2012.
Bentsur further said, "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."
Aeterna Zentaris' President and CEO Juergen Engel noted that the company is currently conducting further data analyses in collaboration with its licensee partners in order to determine the future development strategy for perifosine.
Aeterna has another drug candidate in phase III testing - AEZS-130, a diagnostic test for growth hormone deficiencies.
"Our other ongoing late-stage programs with AEZS-108 and AEZS-130, as well as earlier-stage programs from our deep pipeline will continue as planned, with a sufficient cash position to pursue these programs for more than the next 12 months," Engel added.
In pre-market activity, Keryx shares slumped $2.99 or 60.04 percent to trade at $1.99, while Aeterna shares lost $1.35 or 63.08 percent to trade at $0.79.
by RTT Staff Writer
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