In the last one month alone, shares of Keryx Biopharmaceuticals Inc. (KERX: Quote) have gained over 60 percent as investors eagerly await the phase III results of the company's cancer drug candidate KRX-0401 (perifosine) in a colon cancer trial.
For readers who are new to Keryx, here's a brief overview of its pipeline and the upcoming catalysts to watch out for...
Keryx is dedicated to developing therapies for life-threatening diseases including, cancer and renal disease. The company's product pipeline includes, KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent, and Zerenex (ferric citrate) an oral, iron-based compound.
KRX-0401 is under phase III studies in the indications of multiple myeloma and colorectal cancer - conducted under Special Protocol Assessment agreements reached with FDA, and under phase II trials for multiple other forms of cancer. KRX-0401 is in-licensed by Keryx from Aeterna Zentaris Inc. (AEZS) (AEZ.TO) in the United States, Canada and Mexico.
The phase III trial evaluating KRX-0401 in patients with refractory advanced colorectal cancer is nicknamed "X-PECT". In the X-PECT study, KRX-0401 in combination with Roche's Xeloda (capecitabine) is compared with placebo and Xeloda. The trial has enrolled over 465 patients and its primary endpoint is overall survival, with secondary endpoints including, overall response rate (complete + partial responses), progression-free survival and safety.
Colorectal cancer is the third most common form of cancer diagnosed in the U.S. The American Cancer Society estimates that about 143,000 people will be diagnosed with some form of colorectal cancer with approximately 51,000 patients dying from colorectal cancer in 2012.
The approved drugs for patients with metastatic colorectal cancer are 5-FU; 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.
The X-PECT study is scheduled to be completed this month and top-line data is anticipated to be reported within several weeks thereafter, according to Keryx.
KRX-0401 is also under a phase III registration clinical trial in relapsed / refractory multiple myeloma patients. The study compares KRX-0401 against placebo when combined with Velcade and dexamethasone, and was initiated in December 2009. This trial is designed to enroll approximately 400 patients and data will be unblinded after 265 events (defined as disease progression or death), according to the company.
Yet another late-stage compound of Keryx is Zerenex, which is under phase III testing as a treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease, also under an SPA agreement with the FDA. The compound is in phase III development in Japan too by Keryx's Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd. Keryx acquired the exclusive worldwide rights, excluding certain Asian-Pacific countries, for the development and marketing of Zerenex from Panion & BF Biotech Inc. in November 2005.
The Zerenex phase III clinical program in the U.S. consists of a short-term efficacy study and a 58-week long-term safety and efficacy study. Last April, Keryx announced positive final data from Zerenex short-term phase III study.
The long term phase III study of Zerenex is ongoing and is expected to be completed in the fourth quarter of 2012.
A quick look at the company's balance sheet...
Since inception in 1998, Keryx has incurred significant losses, and as of December 31, 2011, had an accumulated deficit of $369.9 million. The company has no marketed drugs and has generated revenue from the licensing of rights to Zerenex in Japan to JT and Torii. The company ended the year 2011 with $39.5 million in cash.
Keryx went public in July 2000, offering its shares at $10 each. The stock has thus far hit a 52-week low of $2.27 and 52-week high of $5.55. The stock is currently down 1.93% at $4.97.
Will the X-PECT study keep up with investors' expectations? Stay tuned...
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by RTT Staff Writer
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