CellPro Inc. has started a Phase III trial of its Ceprate SC stem cellconcentration system for a new indication following the FDA'sdecision earlier this month not to approve the cell purificationprocedure for autologous bone marrow transplants.
In the new trial, which will take about two years to complete, theBothell, Wash.-based company will test its Ceprate stem cellpurification system in autologous peripheral blood stem celltransplants for patients with advanced multiple myeloma. The trialwill involve 134 patients at multiple sites in the U.S. and one site inToronto.
The Ceprate SC system is designed to capture and purify CD34antigen-expressing stem cells, separating them from tumor cells,before the CD34 cells are transplanted back in the patient.
Lee Parker, CellPro's spokesman, said the two primary endpoints forthe trial are to demonstrate the Ceprate system's effectiveness inreducing or eliminating tumor cells from purified peripheral bloodand to show the procedure is safe.
As for the FDA's ruling in early January on the Ceprate SC systemfor bone marrow transplants, Parker said CellPro has requested ameeting with the FDA's Center for Biologics Evaluation andResearch to discuss the regulatory agency's issues. The approvalapplication for the Ceprate SC system was supported by Phase IIItrials involving patients with metastatic breast cancer.
The Ceprate SC system is on the market in France and Canada and isbeing used by other companies and institutions in more than 60clinical trials.
CellPro's stock (NASDAQ:CPRO) closed Tuesday at $11.12, up 19cents. _ Charles Craig
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