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Keryx Biopharmaceuticals Announces Phase 2 Data for KRX-0401 (Perifosine) in Hodgkin's Lymphoma Presented at ASH Meeting
Date:12/13/2011

NEW YORK, Dec. 13, 2011 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) (the "Company") today reported that encouraging clinical data from a Phase 2 clinical study in patients with refractory/relapsed Hodgkin's Lymphoma was presented yesterday during the Annual Meeting of the American Society of Hematology, which is currently being held in San Diego, California. In a poster presentation by Anna Guidetti, MD, Fondazione IRCCS Instituto Nazionale Tumori, Milan, Italy, preliminary response data showed that perifosine combined with sorafenib significantly increased median progression free survival (PFS) in refractory/relapsed Hodgkin's Lymphoma patients with high phosphorylation levels of Erk and Akt as compared to patients with low baseline phosphorylation levels of Erk and Akt. 

The Phase 2 Study

In abstract # 3705, entitled "Phosphorylation Levels of Extracellular-Signal Regulated Kinase (Erk) and Akt in Circulating Lymphocytes Predict Response to Targeted Therapy with Perifosine and Sorafenib in Refractory/Relapsed Hodgkin Lymphoma Patients,"  phosphorylation levels of Erk (pErk) and Akt (pAkt) were evaluated in circulating lymphocytes from patients enrolled in two consecutive Phase 2 trials evaluating the activity and safety of sorafenib as a single agent or in combination with perifosine in relapsed/refractory Hodgkin Lymphoma patients.

Four patients were treated with sorafenib alone at a dose level of 400mg BID and twenty-one patients received a 4-week treatment with perifosine alone at a dose level of 50mg BID followed by a perifosine/sorafenib combination therapy with 50mg BID and 400mg BID, respectively. Circulated lymphocytes were evaluated for their phosphorylation levels of Erk and
Akt in order to assess predictive value of the phosphokinase levels for therapy responses.

Results

Clinical response data showed that baseline pErk and pAkt levels were significantly higher in responsive patients as compared to unresponsive patients. The pErk and pAkt levels measured after 60 days of therapy with perifosine combined with sorafenib were significantly reduced in responsive patients. The median baseline value of pErk and pAkt efficiently discriminated responsive and unresponsive patients which was associated with a significantly improved median PFS for patients with baseline pErk ≥43% and/or pAkt > 23%.

Conclusions

Refractory/relapsed Hodgkin Lymphoma patients with increased baseline levels of pErk and pAkt demonstrated increased PFS when treated with perifosine in combination with sorafenib.

A copy of the above referenced abstract can be viewed online through the ASH meeting website, http://ash.confex.com/ash/2011/webprogram/start.html.

KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA).

KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.

About Hodgkin's  Lymphoma

Hodgkin's Lymphoma (HL) is a cancer of the immune system. The two major types of HL are classical HL and nodular lymphocyte-predominant HL. The most common symptom of HL is the painless swelling of the lymph nodes in the neck, underarm or chest. Other symptoms include fever, weight loss, fatigue, or night sweats. According to the National Cancer Institute, there will be 8,830 news cases of HL in the United States in 2011, resulting in 1,300 deaths.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the Food and Drug Administration (FDA). Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 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 and cost-effectively complete clinical trials for KRX-0401 (perifosine); the risk that the data (both safety and efficacy) from the ongoing Phase 3 clinical trial will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company, or will not meet the key efficacy and safety parameters specified in the Special Protocol Assessment; and 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 undertake 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 found on our website and the American Society of Hematology's meeting website is not incorporated by reference into this press release and is included for reference purposes only.

KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com


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SOURCE Keryx Biopharmaceuticals, Inc.
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