Business Week
A late-state clinical trial has started for the potential colorectal cancer treatment perifosine, according to a statement Thursday from Keryx Biopharmaceuticals Inc. and AEterna Zentaris Inc.
Keryx, which is based in New York, said the study is expected to be completed in the second half of 2011 and will involve 430 patients with refractory advanced colorectal cancer. Enrollment will take 12 to 14 months.
Keryx and AEterna Zentaris, a Canadian company, are partnering on perifosine in North America. AEterna Zentaris has the rights to the drug in the rest of the world excluding South Korea.
The companies said earlier this week the Food and Drug Administration gave perifosine a "fast track" designation, which allows for a faster review of a potential treatment intended for a serious or life-threatening disease.
In December, perifosine received a fast-track review designation as a potential treatment for multiple myeloma.
Perifosine also has orphan drug status, which is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.
Keryx and AEterna Zentaris, a Canadian company, are partnering on perifosine in North America. AEterna Zentaris has the rights to the drug in the rest of the world excluding South Korea.
The companies said earlier this week the Food and Drug Administration gave perifosine a "fast track" designation, which allows for a faster review of a potential treatment intended for a serious or life-threatening disease.
In December, perifosine received a fast-track review designation as a potential treatment for multiple myeloma.
Perifosine also has orphan drug status, which is given to drugs aimed at rare conditions or conditions that have a lack of treatments on the market. Incentives include seven years of market exclusivity following FDA approval, assistance in clinical trial design, a reduction in user fees, and tax credits.
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