CellPro Inc.'s stock was unchanged Tuesday following a 27.5percent fall last week when the FDA declined to approve the Bothell,Wash.-based company's Ceprate SC stem cell concentration systemfor autologous bone marrow transplants.
The FDA said CellPro's premarketing approval (PMA) application,submitted in December 1993, must be amended to satisfy variousconcerns about the stem cell purification system before it can bereconsidered.
The regulatory agency indicated additional studies may have to beconducted, but CellPro officials said Tuesday they won't decide howto proceed until discussing the issues with the FDA's Center forBiologics Evaluation and Research.
CellPro's stock (NASDAQ:CPRO) closed Tuesday at $9.87,unchanged from Friday when the price dropped $3.75, or 27.5percent.
Lee Parker, spokesman for CellPro, said the company expects tomeet with FDA officials this month. Among the issues raised by theFDA are safety concerns.
In a prepared statement, CellPro's president and CEO, RichardMurdock, said he expects the Ceparate SC system ultimately to beapproved by the FDA.
CellPro's Ceprate technology is designed to capture and purify rarecell populations. The Ceparate SC stem cell system targets CD34+cells, which replicate to form cells of the blood and immune system.
The PMA for the Ceprate SC system was supported by results fromPhase III trials for autologous bone marrow transplants in thetreatment of metastatic breast cancer. The trials' investigatorsconcluded the system achieved its two primary endpoints ofproviding engraftment equivalent to standard bone marrowtransplants and of reducing cardiovascular side effects from themarrow infusions.
Parker said the delay in getting the FDA approval has not resulted inany immediate changes to the company. He said the FDA's actionalso should not affect use of the Ceprate SC system in more than 60clinical trials being conducted by other companies and researchinstitutions.
The system is on the market in France, which does not regulate suchdevices, and Canada, which recently approved its use.
Parker said CellPro anticipates European Union approval in mid-1995, clearing the way for sale of the system throughout Europe.
The PMA is CellPro's first application for its Ceprate SC systemwith the FDA. n
-- Charles Craig
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