Patients eligible for the Phase 3 trial must have been previously treated with both bortezomib (Velcade(R)) and an immunomodulatory agent (Revlimid(R) and/or Thalidomid(R)), and been previously treated with one to four prior lines of therapy. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. Patients can be relapsed from and refractory to all non-bortezomib based therapies, however, patients can only be relapsed (progressed more than 60 days after discontinuing therapy) from prior bortezomib-based therapies. The study is powered at 90% to demonstrate the required difference in progression-free survival between the two arms. Approximately 265 events (defined as disease progression or death) will trigger the un-blinding of the data.
The Company expects a patient recruitment period of approximately 16-18 months, with study completion expected within approximately 20-22 months from today.
About Perifosine (KRX-0401)
Perifosine is a novel oral anticancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. Perifosine has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. Perifosine is currently in a Phase 3 trial, under Special Protocol Assessment (SPA), in multiple myeloma for which it has received Orphan Drug and Fast Track designations from the FDA in this indication. Perifosine is also in Phase 2 clinical trials for several other tumor types.
About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but t
|SOURCE AETERNA ZENTARIS INC.|
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