NEW YORK, May 16, 2005 (PRIMEZONE) -- Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) announced today that Phase 2 data presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida demonstrated the tolerability and potential efficacy of KRX-0401 (perifosine) in the treatment of patients with biochemically recurrent hormone-sensitive prostate cancer (HSPC). This study was conducted by a consortium of cancer centers under the leadership of the University of California, Davis pursuant to a Collaborative Research and Development Agreement (CRADA) between Keryx and the National Cancer Institute. KRX-0401 is a novel, oral, anticancer agent that modulates Akt and several other important signal transduction pathways, including MAP kinase and JNK.
This single-agent Phase 2 multi-center study of KRX-0401 enrolled 25 patients with HSPC who had received prior prostatectomy and/or radiation treatment and had a rising PSA without radiographic metastasis. In the study, the patients received a loading dose of KRX-0401 of 900mg on day one, in divided doses of at least 6 hours apart, then 100mg daily. Of the 25 patients enrolled, 22 were evaluable for response. Of the evaluable patients, 18 patients (82%) had stable disease and 3 (14%) had PSA progression. While no patients had a greater than 50% reduction in PSA, 3 patients (14%) had a minor response demonstrated by a PSA reduction of less than 50%. Grade 3-4 toxicities included grade 3 hyponatremia, arthritis, hyperuricemia and vision change.
The authors concluded that KRX-0401 in HSPC patients is feasible, well-tolerated and can reduce PSA by less than 50% in some patients. Because of its inhibitory effects on the P13K/AKT pathway, further studies of KRX-0401 in combination with androgen ablation and chemotherapy are warranted.
I. Craig Henderson, M.D., President of Keryx Biopharmaceuticals, commented, "We are very encouraged by these data. The level of activity seen in this study provides us with additional evidence of the potential utility of KRX-0401 in the treatment of various forms of prostate cancer. We anticipate initiating several studies of KRX-0401 in patients with various stages of prostate cancer this year."
Michael S. Weiss, Chairman and Chief Executive Officer of Keryx, added, "We are very pleased with the results of this study. These data provide additional evidence of KRX-0401's potential anti-cancer activity and provide a strong basis for further studies in prostate cancer, which we plan to initiate this year. Our goal remains to provide data from our corporate sponsored clinical program later this year or early next year that will lead us to one or more regulatory approval pathways."
To access the abstract, entitled "The AKT Inhibitor Perifosine in Biochemically Recurrent Prostate Cancer (HSPC): A Phase 2 California Cancer Consortium Trial" please click on www.keryx.com/pr/0401abstract.pdf.
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.
ABOUT KRX-0401 (Perifosine)
KRX-0401 (Perifosine) is a novel, first-in-class, oral anticancer agent that modulates Akt and several other key signal transduction pathways, including MAPK and JNK that have been shown to be critical for the survival and proliferation 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, sarcomas 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.