Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
NEW YORK, February 26, 2009 /PRNewswire-FirstCall/ --<!-- cpurl --> Keryx Biopharmaceuticals<!-- /cpurl -->, Inc. today announced updated clinical results from an ongoing Phase 1/2 study of <!-- ppurl -->KRX-0401<!-- /ppurl --> (<!-- ppurl -->perifosine<!-- /ppurl -->) in combination with <!-- ppurl -->bortezomib<!-- /ppurl --> (+/- <!-- ppurl -->dexamethasone<!-- /ppurl -->) in patients with relapsed/refractory multiple myeloma. The data, which was presented earlier today in a poster featured at the 12th International Multiple Myeloma Workshop in Washington, DC, highlights a subset analysis of the bortezomib-relapsed patients who were evaluable at the time of this report.
Data from this Phase 1/2 study were previously presented in December 2008 at the American Society of Hematology meeting via an oral presentation entitled "A Multicenter Phase 1/2 Study Evaluating the Safety and Efficacy of Perifosine (KRX-0401) + Bortezomib (<!-- ppurl -->VELCADE<!-- /ppurl -->(R)) in Patients with Relapsed or Relapsed / Refractory Multiple Myeloma Who Were Previously Treated with Bortezomib." Updated results from this fully enrolled study are as follows:
Eighty-four patients were enrolled in a combined Phase 1/2 study (18 patients in the Phase I component and 66 patients in the Phase II component). At the time of this analysis, 73 patients were evaluable for response. Median prior lines of therapy was 5 (range 1 - 13), including; 100% of patients had been treated with bortezomib (50% of the patients were previously treated with at least 2 bortezomib-based therapies and 81% were previously treated with bortezomib plus dexamethasone); 98% of patients were previously treated with dexamethasone; 99% of patients were previously treated with <!-- ppurl -->lenalidomide<!-- /ppurl --> (<!-- ppurl -->Revlimid<!-- /ppurl -->(R)) and/or <!-- ppurl -->thalidomide<!-- /ppurl --> (<!-- ppurl -->Thalomid<!-- /ppurl -->(R)); and 57% of patients had prior stem cell transplant. No unexpected adverse events have been seen. Toxicities were manageable with supportive care and/or dose reductions as required.
Best response (MR or better) and stable disease (no progression for 3 months) to either perifosine + bortezomib (+/-dexamethasone) for patients previously relapsed from or refractory to prior bortezomib treatment was as follows:
Evaluable Patients CR PR MR ORR SD > 3 mos Bortezomib Relapsed (n=20) 2 10% 6 30% 3 15% 11 55% 9 45% Bortezomib Refractory (n=53) 1 2% 6 11% 10 19% 17 32% 24 45% All Evaluable Patients (n=73) 3 4% 12 16% 13 18% 28 38% 33 45%
Patients who had previously relapsed on a bortezomib-based treatment had a median time to progression (TTP) of 8.5 months. The median TTP for all 73 evaluable study patients (both bortezomib relapsed and refractory) was 6.4 months. As of the report, 16 patients remain on active treatment.
Commenting on the data, Dr. Paul Richardson stated "Perifosine in combination with bortezomib and dexamethasone continues to demonstrate an impressive response rate and time to progression in a heavily pre-treated patient population, with 83% of evaluable patients achieving stable disease or better. Particularly noteworthy is the benefit observed in patients who relapsed on prior bortezomib-based therapy, as reflected by an 8.5 month median time to progression in our study. We continue to be encouraged by the data and look forward to evaluating this combination in a randomized phase 3 trial."
Michael S. Weiss, Chairman and CEO of Keryx Biopharmaceuticals, remarked, "We believe these data confirm the activity of perifosine both in patients who have relapsed following bortezomib therapy and in those patients who were refractory to bortezomib. We continue to be encouraged by the evolving data on the combination of perifosine and bortezomib in patients with multiple myeloma."
One additional multiple myeloma clinical poster was presented as follows:
Phase 1 Updated Results of Perifosine (KRX-0401) in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (MM)
Perifosine in combination with Revlimid(R) + dexamethasone continues to be well tolerated, with a median progression-free survival in responding patients of 10.9 months. Median overall survival still has not been reached now at 17 months. Nine patients remain on active treatment.
KRX-0401 (perifosine) is in-licensed by Keryx from <!-- cpurl -->Aeterna Zentaris<!-- /cpurl -->, Inc. in the United States, Canada and Mexico.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important, novel pharmaceutical products for the treatment of life-threatening diseases, including renal disease and cancer. Keryx is developing <!-- ppurl -->Serene<!-- /ppurl -->(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. Serene is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease. The Company is also developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, a protein in the body associated with tumor survival and growth. KRX-0401 also modulates a number of other key signal transduction pathways, including the JNK and MAPK pathways, which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 is currently in Phase 2 clinical development for multiple tumor types. The Company also has an in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.
Some of the statements included in this press release, particularly those anticipating future clinical 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 complete clinical trials for KRX-0401; our ability to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; 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 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 http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT: Lauren Fischer Director - Investor Relations Keryx Biopharmaceuticals, Inc. Tel: 212.531.5965 E-mail: firstname.lastname@example.org
CONTACT: Lauren Fischer, Director of Investor Relations of KeryxBiopharmaceuticals, Inc., +1-212-531-5965, or email@example.com
Web site: http://www.keryx.com/
Ticker Symbol: (Toronto:AEZ.),(NASDAQ-NMS:AEZS),(NASDAQ-NMS:KERX)
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Posted: February 2009