Key DevelopmentsKeryx Biopharmaceuticals Announces Special Protocol Assessment Agreement With FDA For Phase 3 Trial Of KRX
8:30am EST
Keryx Biopharmaceuticals announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer. The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.
AEterna Zentaris Inc. Partner Keryx Biopharmaceuticals Announces Positive Phase 2 Results For Perifosine As A Single Agent For Treatment Of Advanced Waldenstrom's Macroglobulinemia
Friday, 29 Jan 2010 08:35am EST
AEterna Zentaris Inc. announced that an article entitled Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia, reporting Phase 2 data demonstrating the single agent activity of perifosine (KRX-0401) for the treatment of advanced Waldenstrom's Macroglobulinemia (Waldenstrom's), will appear in the February 1, 2010, issue of the Journal of Clinical Cancer Research. Perifosine, AEterna Zentaris's oral PI3K/Akt pathway inhibitor is currently being investigated in a Phase 3 trial, under Special Protocol Assessment, for the treatment of Multiple Myeloma. Like Multiple Myeloma and Non-Hodgkin's Lymphoma, Waldenstrom's is a hematologic disease in which the cancer cells target the bone marrow. Keryx Biopharmaceuticals is AEterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while AEterna Zentaris retains rights for the rest of the world. Dr. Irene Ghobrial, Assistant Professor of Medicine, Bing Center for Waldenstrom's Macroglobulinemia at Dana-Farber Cancer Institute, led the Phase 2 study in which 37 patients were treated with perifosine 150 mg daily for 6 cycles. In this study, 41% of the patients had 3 or more lines of prior therapy and 78% had 2 or more prior lines of therapy.
Keryx Biopharmaceuticals Reports Benefit In Survival From Updated Results Of Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of KRX-0401
Monday, 25 Jan 2010 08:30am EST
Keryx Biopharmaceuticals announced that it has reported updated results on the clinical activity of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colon cancer. In this randomized, double-blind, placebo controlled study conducted at 11 centers across the United States, heavily pre-treated patients with second- or third-line metastatic colon cancer were randomized to receive capecitabine (a chemotherapy used in advanced metastatic colon cancer which is marketed by Roche as Xeloda) at 825 mg/m2 BID (total daily dose of 1650 mg/m2) on days one - 14 every 21 days plus either perifosine or placebo at 50 mg daily. The study enrolled a total of 38 patients, 34 of which were third-line or greater. Of the 38 patients enrolled, 35 patients were evaluable for response (20 patients on the perifosine + capecitabine arm and 15 patients on the placebo + capecitabine arm). Three patients on the placebo + capecitabine arm were not evaluable for response (two patients were unevaluable due to toxicity (days 14, 46) and one was unevaluable due to a new malignancy on day six). All patients in the perifosine + capecitabine arm were evaluable for response. The patients in the study were heavily pre-treated, with the arms well-balanced in terms of prior treatment regimens. KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement With FDA For Phase 3 Registration Program Of Zerenex In Treatment Of Hyperphosphatemia
Tuesday, 5 Jan 2010 08:30am EST
Keryx Biopharmaceuticals announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD). The SPA provides agreement that the Phase 3 program design adequately addresses objectives in support of a regulatory submission for drug approval. In accordance with the Company's SPA agreement with the FDA, the Phase 3 clinical program for Zerenex will consist of two clinical studies, as follows: Short-term efficacy study: A multicenter, randomized, open-label clinical trial with a planned enrollment of approximately 150 patients on hemodialysis, who will be randomized to fixed doses of Zerenex, ranging from one gram per day to eight grams per day, for a treatment period of 28 days. Patients will undergo a two week washout period prior to randomization. The primary endpoint of the study will be to demonstrate a dose response in the change of serum phosphorous from baseline (end of washout period) to end of the treatment period (day 28). This short-term study is expected to commence by the end of the first quarter of 2010, with data expected in the second half of 2010.
Keryx Biopharmaceuticals Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) For Treatment Of Patients With Advanced Multiple Myeloma
Wednesday, 16 Dec 2009 08:30am EST
Keryx Biopharmaceuticals announced the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor, in relapsed or refractory multiple myeloma patients. The trial, entitled, a Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib (Velcade) and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib is a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade) and dexamethasone. The trial will enroll approximately 400 patients with relapsed or relapsed or refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication. An estimated 40 to 50 centers throughout the United States and select centers outside of the United States will be participating in this Phase 3 trial.
AEterna Zentaris Inc. Partner Keryx Biopharmaceuticals Reports Updated Phase 1/2 Data, Including New Survival Data On Perifosine (KRX-0401) In The Treatment Of Advanced Multiple Myeloma
Monday, 7 Dec 2009 08:35am EST
AEterna Zentaris Inc. announced that its partner Keryx Biopharmaceuticals reported updated efficacy and safety data as well as new survival data on the clinical activity of perifosine (KRX-0401) in combination with bortezomib (Velcade) (+/- dexamethasone) in patients with relapsed/refractory multiple myeloma. Data from the study entitled A Multicenter Phase 1/2 Study Evaluating the Safety and Efficacy of Peri