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news.Æterna Zentaris, a late-stage drug development company specialised in oncology and endocrine therapy, has initiated Phase 3 registration clinical trial with Perifosine (KRX-0401).
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Perifosine is company’s new oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.
Reportedly, the trial is sponsored and conducted by Keryx Biopharmaceuticals, Æterna Zentaris’ partner and licensee for Perifosine in the US, Canada and Mexico. Æterna Zentaris has also out-licensed Perifosine to Handok in South Korea, while retaining rights for the rest of the world.
Æterna Zentaris said that the Phase 3 trial, entitled ‘X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) trial,’ is being conducted pursuant to a Special Protocol Assessment (SPA) with the FDA.
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.
Additionally, the X-PECT study will be powered at 90% to detect 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.
Perifosine has also been granted fast track designation for the treatment of refractory advanced colorectal cancer. Approximately 40 to 50 US 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.
Johanna Bendell, director of GI Oncology Research for the Sarah Cannon Research Institute, Nashville, Tennessee, is expected to lead the Phase 3 investigational team that includes Cathy Eng, associate medical director for the Colorectal Center at MD Anderson Cancer Center in Houston, Texas.
Juergen Engel, president and CEO of Æterna Zentaris, said: “We are very pleased with the initiation and sponsorship of this key registration Phase 3 trial in refractory advanced colorectal cancer in North America which our partner Keryx expects to complete in the second half of 2011, with product launch, in the USA, in 2012.
“These data will be very supportive of our efforts to register Perifosine in the rest of the world, where in some countries, we expect they will be sufficient to do so without any additional studies.”