Keryx Biopharmaceuticals, Inc. Announces Positive Interim Phase II Data on KRX-0401 (Perifosine) in Patients with Relaps
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 (<25% reduction in M-protein) in 13 patients (39%). Dex was added in 30 of 55 patients with PD, with 23 patients evaluable for response on the combination, reported as follows: Perifosine Dex N (%) Duration (wks) PR 2 (9%) 13 , 17 MR 4 (17%) 4, 16 , 28 , 30 Stable Disease 11 (48%) 6 - 20 (median 18)* *4 pts ongoing at 16, 18, 20 and 20 weeks The most common grade 3/4 adverse events were nausea (7%); vomiting (4%); diarrhea (2%); fatigue (2%), and increased creatinine (8% in the context of PD and light chain nephropathy). Dose reduction (150 to 100 or 50 mg/d) was required in 16 patients and 7 patients discontinued treatment due to adverse events. Attributable toxicities otherwise proved manageable with appropriate supportive care. Perifosine was generally well tolerated, with no peripheral neuropathy or DVT seen. The conclusion of the investigators is that Perifosine alone or in combination with dexamethasone has activity in patients with advanced, relapsed/refractory MM, achieving response and/or stabilization of disease in 69% of evaluable patients to date. Commenting on the interim data, Dr. Richardson stated, "We are encouraged by the observed activity of perifosine in combination with dexamethasone in relapsed and refractory patients with multiple myeloma, and the manageable toxicity profile seen to date, with some of our patients remaining on active treatment over 6 months. We look forward to completing enrollment in this study while moving forward with clinical trials evaluating perifosine in combination with other novel agents, including bortezomib." Craig Henderson, MD, President of Keryx Biopharmaceuticals, commented, "We are excited with the KRX-0401 interim phase II clinical results in multiple myeloma. We are grateful to see top institutions in the field coming together led by Dr. Paul Richardson, to conduct this important clinical program for KRX-0401."