Aeterna Zentaris Announces Initiation of Phase 3 Registration Trial with Perifosine in Refractory Advanced Colorectal Cancer
Phase 3 X-PECT Trial (Xeloda(R)) + Perifosine Evaluation in Colorectal Cancer Treatment) being conducted by partner Keryx Biopharmaceuticals pursuant to Special Protocol Assessment with the Food and Drug Administration
The Phase 3 trial, entitled “X-PECT (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) trial”, is being conducted pursuant to a Special Protocol Assessment (“SPA”) with the Food and Drug Administration. Perifosine has also been granted Fast Track designation for the treatment of refractory advanced colorectal cancer. Approximately 40 to 50 U.S. sites will participate in the study. Keryx expects enrollment to take approximately 12 – 14 months, with study completion expected in the second half of 2011.
Phase 3 Trial Design
The Phase 3 X-PECT (Xeloda(R) + Perifosine Evaluation in Colorectal cancer Treatment) trial is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda(R)) vs. placebo + capecitabine in approximately 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5-fluorouracil (5-FU), oxaliplatin (Eloxatin(R)), irinotecan (Camptosar(R)), bevacizumab (Avastin(R)) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux(R)) or panitumumab (Vectibix(R)). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint is overall survival, with secondary endpoints including overall response rate (complete + partial responses), progression-free survival and safety. The median overall survival for the X-PECT study’s targeted patient population, that has failed prior therapies as described above, is approximately 5 months. The X-PECT study will be powered at 90% to detect a statistically significant difference in overall survival, with an assumed median overall survival for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the unblinding of the study.
Perifosine is a novel, potentially first-in-class, oral anti-cancer agent that modulates Akt, and a number of other key signal transduction pathways, including the JNK and MAPK pathways, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. The effects of perifosine on Akt are of particular interest because of the importance of this pathway in the development of most cancers, with evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy, and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity. High levels of activated Akt (pAkt) are seen frequently in many types of cancer and have been correlated with poor prognosis.
About Colorectal Cancer
According to the American Cancer Society, colorectal cancer is the third most common form of cancer diagnosed in
About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy. News releases and additional information are available at www.aezsinc.com.
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