Keryx Biopharmaceuticals, Inc. Announces Positive Interim Phase II Data on KRX-0401 (Perifosine) in Patients with Relapsed and R
December 11 2006 - 10:35AM
PR Newswire (US)
Interim data analysis show induction of response and/or disease
stabilization in 69% of evaluable patients in combination with
Dexamethasone NEW YORK, Dec. 11 /PRNewswire-FirstCall/ -- Keryx
Biopharmaceuticals, Inc. (NASDAQ:KERX) today announced that Dr.
Paul Richardson, Clinical Director of the Jerome Lipper Multiple
Myeloma Center at the Dana-Farber Cancer Institute (DFCI) in
Boston, MA reported positive interim results from the phase II
study of KRX-0401 in patients with advanced relapsed and refractory
multiple myeloma (MM) at the American Society of Hematology (ASH)
48th Annual Meeting and Exposition in Orlando, FL. KRX-0401, the
Company's lead oncology compound under development, is a novel,
oral, anticancer agent that modulates Akt and several other
important signal transduction pathways, including MAP kinase and
JNK. KRX-0401 is currently being evaluated in Phase II clinical
trials as a single agent and in combination with other anti-cancer
agents across several tumor types. Dr. Richardson, along with Dr.
Ken Anderson at DFCI and other leading investigators from MM
centers including Emory University, University of Michigan, Alta
Bates, City of Hope, University of Virginia and Northwestern
University have been instrumental in the pre-clinical and clinical
development of perifosine for MM. The poster (Abstract # 3582),
entitled "A Multicenter Phase II Study of Perifosine (KRX-0401)
Alone and in Combination with Dexamethasone (Dex) for Patients with
Relapsed or Relapsed/Refractory Multiple Myeloma (MM)," was
presented today, December 11th, 2006 at 10:30 am in the Orange
County Convention Center. In this ongoing Phase II study, patients
with relapsed or relapsed/refractory multiple myeloma are treated
with KRX-0401 (150 mg oral daily dose) to assess the single agent
activity of KRX-0401 in this patient population. If a patient
progresses on KRX-0401 alone, dexamethasone (20mg twice weekly) is
added to their KRX-0401 regimen. Results: 55 patients (30 men and
25 women, median age 63 y, range 3879) have been treated to date.
All had relapsed and refractory MM, with a median of 4 lines of
prior treatment (range 2 - 11). Prior therapy included dex (95%),
thalidomide (89%), bortezomib (78%), lenalidomide (31%) and stem
cell transplant (73%). Among 33 patients currently evaluable for
response, best response (EBMT/Blade criteria) to single agent
perifosine after 2 cycles was stable disease (