NEW YORK, May 11, 2005 (PRIMEZONE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that the results of a phase II trial of KRX-0401 (perifosine) for patients with early prostate cancer will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. The presentation entitled "The AKT Inhibitor Perifosine in Biochemically Recurrent Prostate Cancer (HSPC): A Phase 2 California Consortium Trial" is scheduled for Saturday, May 14, 2005, from 8:00 a.m. to 12:00 p.m. EDT, in Hall C, level 2 of the Conference Center. KRX-0401 is a novel, oral, first-in-class inhibitor of AKT and other important signal transduction pathways.
Keryx also announced that the following combination clinical studies have now been initiated as part of its corporate-sponsored clinical program for KRX-0401:
-- Phase II combination study of KRX-0401 and Trastuzumab
(Herceptin)(r), an approved human monoclonal antibody
for the treatment of metastatic breast cancer. This
multi-center Phase II trial will evaluate KRX-0401 in
combination with Herceptin in breast cancer patients
whose tumors overexpress HER2/neu and who have failed
previous treatments with Herceptin(r) or Herceptin(r)
plus chemotherapy.
-- Phase II study of KRX-0401 in combination with endocrine
therapy for patients with estrogen receptor or progesterone
receptor positive metastatic breast cancer.
Other studies that have been initiated pursuant to the Keryx-sponsored clinical program include:
-- A single-agent phase I/II trial of Perifosine in the
treatment of non-small cell lung cancer.
-- A phase I trial of the combination of perifosine
and paclitaxel.
-- A phase I trial of the combination of perifosine and
docetaxel.
-- A phase I trial of the combination of perifosine and
gemcitabine.
-- A single-agent phase II trial of perifosine in patients
with various tumors for which no standard therapy exists
either because the tumors have become unresponsive to standard
treatments or no effective form of systemic therapy
has been established.
In addition to the corporate sponsored clinical program for KRX-0401, Keryx has ongoing clinical and preclinical collaborations with several prestigious medical institutions and universities, including Memorial Sloan-Kettering, MD Anderson, Dana Farber, UCSF, Emory, the National Cancer Institute and the Netherlands Cancer Institute.
Dr. Henderson commented, "Having been intimately involved as a principal investigator in the development of Herceptin(r), I am very enthusiastic about the Herceptin(r) -- KRX-0401 combination approach. I've also been very closely associated with the development of various endocrine therapies. Pre-clinical studies provide a strong rationale for undertaking these KRX-0401-Herceptin(r) and KRX-0401 endocrine therapy combination studies." Dr. Henderson added, "These studies represent the first non-chemotherapy combination studies that we have initiated. We look forward to commencing additional biologically designed combination trials for KRX-0401 in the near term."
Michael S. Weiss, Chairman and Chief Executive Officer of Keryx, stated, "We have been aggressively expanding our corporate sponsored clinical program for KRX-0401 and our goal is to start generating important data sets from this program later this year and into early next year. We also look forward to initiating additional KRX-0401 single-agent and combination studies in the near term as we continue to expand the breadth of our clinical program for the drug."
KRX-0401 (Perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (TSX:AEZ) (Nasdaq:AEZS), which holds ex-North American rights to the drug.
Herceptin(r) is a trademark of Genentech, Inc.
ABOUT KRX-0401 (Perifosine)
KRX-0401 (Perifosine), a novel, first-in-class, oral anticancer agent that modulates several key signal transduction pathways, including AKT, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. KRX-0401 has demonstrated single agent anti-tumor activity in Phase I and Phase II studies and is currently being studied as a single agent and in combination with several forms of anti-cancer treatments for various forms of cancer, including non-small cell lung cancer and breast cancer.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) is focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer. Keryx is developing KRX-101 (sulodexide), a novel first-in-class oral heparinoid compound for the treatment of diabetic nephropathy, which is in a Phase 2 clinical program and for which a pivotal Phase 3 and Phase 4 program is pending commencement under an SPA with the FDA. Additionally, Keryx is developing clinical-stage oncology compounds, including KRX-0401, a novel, first-in-class, oral modulator of Akt and other important signal transduction pathways, which is in Phase 2 clinical development. Keryx also has an active in-licensing and acquisition program designed to identify and acquire clinical-stage drug candidates. Keryx Biopharmaceuticals is headquartered in New York City.
Some of the statements included in this press release, particularly those anticipating future financial performance, characteristics of and prospects for the KRX-0401 clinical trial programs, timing of data from the KRX-0401 clinical trials, operating strategies and similar matters, are 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. Important factors may cause our actual results to differ materially, including: our ability to obtain regulatory approval of the use of KRX-0401 as a single-agent; our success in combining KRX-0401 with approved anti-cancer therapies in a manner that will lead to additional approaches to regulatory approval; our ability to successfully and cost-effectively complete our clinical program for KRX-101; and other risk factors identified from time to time in our SEC reports, including, but not limited to, the report on Form 10-K for the year ended December 31, 2004, and our quarterly report on Form 10-Q for the quarter ended March 31, 2005. Any forward-looking statements set forth in this news release speak only as of the date of this news 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 www.keryx.com. The information in Keryx's website is not incorporated by reference into this press release and is included as an inactive textual reference only.